The following was published in the July 20, 2008 issue of the Manila Bulletin newspaper. The source of said info was identified as Jane Kingsu. For their own benefit, it will be wise for people not to believe said Kingsu because her street address was not visible in said newspaper. According to said Kingsu: "Guerlain, with the latest biotechnology, extracted the flowers' cells and came up with the Desert Rose Flower Complex. This new and improved Super Aqua-Serum formula stimulates natural hydration that boosts moisture, defends itself from environmental stress, and fights ageing, too. Guerlain is available at Rustan's Makati and Rustan's Shangri-La Plaza."
about breakfast
http://www.consumeraffairs.com/news04/2008/04/heart_breakfast.html
about medical clinics
http://www.lockergnome.com/forsythe/2008/07/18/a-drawback-of-walk-in-medical-clinics/
about LG Electronics:
http://www.cpsc.gov/cpscpub/prerel/prhtml05/05213.html
NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
June 29, 2005
Release #05-213 LG's Recall Hotline: (888) 294-5782
CPSC Consumer Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
CPSC, LG Electronics and Sears, Roebuck and Co. Announce Recall to Repair Refrigerators
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary retrofit of the following consumer product. Consumers should contact the manufacturer or retailer for further instruction.
Name of Product: LG and Kenmore Elite® Trio™ Three-Door Refrigerators.
Units: About 20,000
Manufacturer: LG Electronics Inc., of Lincolnshire, Ill.
Distributor: Sears, Roebuck and Co., of Hoffman Estates, Ill.
Problem: A faulty component in the condenser fan motor can short circuit. This could cause the condenser fan motor to overheat, posing a potential fire hazard to consumers.
Incidents/Injuries: LG Electronics has received 82 reports of incidents involving a condenser fan motor failure due to a failed capacitor arcing and smoking. There has been smoke damage in a few incidents. There have been no injuries.
Description: The recalled refrigerators are three-door, 21 to 25 cubic foot units with a bottom freezer. The refrigerators come in titanium, stainless steel, bisque, white or black. Brand names are identified on the door at the top right of the units and the interior data plate. The units have the following model and serial numbers located on the data plate inside the fresh food section of the refrigerator door:
Brand Product Model Number Serial Number Range
LG Three-door bottom freezer refrigerator without water dispenser
LRFC21755TT
LRFC21755SB
LRFC21755ST
LRFC25750WW LRFC25750SW
LRFC25750SB
LRFC25750TT
LRFC25750ST
405KRxxxxxxx through 410KRxxxxxxx
*Not all refrigerators within the serial number range are included in the recall. Consumers should call LG or Sears to determine whether their refrigerator is included in the recall.
Sold at: Sears stores nationwide sold the Kenmore brand exclusively and other major retailers nationwide sold the LG brand refrigerators from May 2004 through May 2005 for between $1,400 and $2,400.
Manufactured in: South Korea
Remedy: Consumers should contact Sears or LG to arrange for a free in-home repair.
Consumer Contact: Call LG toll-free at (888) 294-5782 or Sears at (800) 659-7026 between 8 a.m. and 10 p.m. CT Monday through Saturday. Consumers also can log on to http://us.lge.com or www.sears.com for further information on those models included in the repair program and to arrange for an in-home appointment.
http://www.cpsc.gov/cpscpub/prerel/prhtml01/01130.html
CPSC info re LG Electronics recall of Dehumidifiers
NEWS from CPSC
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs Washington, DC 20207
FOR IMMEDIATE RELEASE
April 19, 2001
Release # 01-130 Dehumidifier Recall Hotline: (800) 651-1602
CPSC Consumer Hotline: (800) 638-2772
CPSC Media Contact: Scott Wolfson, (301) 504-7051
CPSC, LG Electronics Inc. Announce Recall of Goldstar, General Electric, and Sears Kenmore Dehumidifiers
WASHINGTON, D.C. - In cooperation with the U.S. Consumer Product Safety Commission (CPSC), LG Electronics Inc., of Seoul, South Korea, is voluntarily recalling about 100,000 Goldstar, General Electric, and Sears Kenmore portable dehumidifiers. These dehumidifiers have an internal electrical connection that can overheat, presenting a potential fire hazard to consumers.
LG Electronics has received seven reports of dehumidifiers overheating, including four reports of fire within the units, with smoke damage to surrounding objects. No injuries have been reported.
The recalled dehumidifiers are white, with a red auto shut off button, and regulators for fan speed and humidity control. The dehumidifiers were manufactured between November 1998 and May 1999, and have the following brand names and model numbers: Goldstar DH2510, DH4010 and DH5010; General Electric AHG25LAG1, AHG40LAG1 and AHG50LAG1; and Sears Kenmore 580.59600890 (60-pint model only). The brand name is located to the left of the control unit. The model number is located behind the condensate bucket, on a sticker on the left hand side.
Mass merchandise and department stores nationwide sold the dehumidifiers from January 1999 through December 1999 for between $100 and $200.
Consumers should stop using the dehumidifiers immediately and call LG Electronics toll-free (800) 651-1602 anytime for a free repair. Consumers also can log on the company's website at www.easyrecalldehumidifier.com.
about emergency medicine
http://www.medpagetoday.com/EmergencyMedicine/EmergencyMedicine/tb/10178
tips for gardeners
http://www.consumeraffairs.com/news04/2008/04/senior_garden.html
http://www.ewg.org/book/export/html/25570
Published on Environmental Working Group (http://www.ewg.org)
EWG's Guide to Infant Formula and Baby Bottles
Summary & Findings
Published December 5, 2007
EWG's Guide to Infant Formula and Baby Bottles
Liquid infant formula from the top manufacturers is sold in cans lined with a toxic chemical linked to reproductive disorders and neurobehavioral problems in laboratory animals, according to an investigation by Environmental Working Group (EWG). The chemical is almost as common in the packaging of powdered formula, with 4 of the top 5 companies acknowledging its use.
The chemical is bisphenol A, or BPA, a component of the plastic epoxy resins used to line metal food cans. Dozens of laboratory studies show that BPA affects the developing brain and reproductive systems of animals exposed to low doses during pregnancy and early life. BPA has recently raised concerns from 2 separate expert panels of the National Institutes of Health (NIH), with 1 group of scientists warning that human exposures to BPA are already at or above the levels that harm animals and another expressing concern about impacts of BPA on infants' brains and behavior.
In October and November 2007, Environmental Working Group surveyed the 5 leading makers of baby formula sold in the U.S. to determine whether they use BPA in their packaging. We found:
* The makers of Nestlé, Similac, Enfamil and PBM (who make store-brand formulas sold at WalMart, Target, Kroger and dozens of other retailers) all said that they use BPA in the linings of metal cans holding liquid formula.
* BPA is widely used in powdered formula containers as well. Every manufacturer except Nestlé said it uses a BPA-based lining on the metal portions of their powdered formula cans. Nestlé failed to provide EWG with reliable documentation of their alternative packaging, and thus is not a clear improvement over other types.
* Powdered formulas are a better choice. Our calculations indicate that babies fed reconstituted powdered formula likely receive 8 to 20 times less BPA than those fed liquid formula from a metal can.
Liquid formula is of greatest concern, and its use could lead to high BPA exposures for babies. Recent studies documenting that BPA leaches out of plastic baby bottles prompted a run on glass bottles by concerned parents. But testing by EWG and by the Food and Drug Administration (FDA) indicates that under normal use, liquid formula itself could expose an infant to substantially more BPA than a plastic bottle.
The safest choice is clear: Breastfeed your baby whenever possible.
Breast milk is the best source of nutrition for babies. It contains essential fatty acids that help bolster babies’ bodies against the impacts of toxic chemicals. However, there are many reasons why families rely on formula for some or all of their baby’s diet. Seventy percent of babies in the U.S. receive some formula by the time they are 3 months old. These babies need a safe and healthy source of food, and formula should be manufactured in a way that avoids contamination with harmful chemicals.
If your child is fed infant formula, you can reduce BPA exposure by choosing powdered formula.
Nestlé, makers of Good Start and Mam brands, repeatedly told EWG researchers that its powdered formula cans contain no BPA. Nestlé's emails to parents repeat this claim, but the company has failed to document this in writing or provide information on their alternative to EWG, despite our numerous requests to the company. In any case, EWG cannot recommend Nestlé baby formula due to the company's long history of ethically suspect infant formula marketing practices in the developing world. Nestlé's claim that it uses BPA-free packaging, if true, would be welcome news, because it suggests that other manufacturers could switch to safer packaging materials and reduce babies' BPA exposures.
Powdered formula sold by Enfamil and Similac are reduced-risk choices, because only the metal tops and bottoms of their packages – not the cardboard sides – are metal and lined with BPA-based plastic. Earth's Best Organic and PBM (which make dozens of store brands) are more of a concern: they are sold in an entirely metal can, which means the formula has more contact with a BPA-coated surface.
If you must choose liquid formula, look for types sold in plastic containers or purchase concentrated – not ready-to-eat – types.
If you buy liquid formulas, look for those sold in plastic containers. If you must use liquid formula sold in metal cans, choose concentrated rather than ready-to-eat formula. Both FDA and EWG have tested samples of liquid formula sold in cans and found BPA in every company’s formula. Choosing a formula that requires dilution with water reduces the amount of BPA in your baby’s diet.
If you don’t know whether your brand is packaged with BPA, ask – and demand a straight answer.
During our initial calls to formula manufacturers, we asked company representatives if their packaging contains BPA, if they test for BPA levels in their products, and if they would disclose their test results to EWG. Many of the companies had a prepared response – “We comply with all FDA regulations regarding BPA and formula” – so it was clear that concerned parents are asking about BPA in formula. We later sent an email, without mentioning EWG, to see whether the information they gave to parents was consistent with what they told us.
PBM, the manufacturer of store brands, told EWG researchers their containers have a BPA lining. However, PBM later sent an EWG staff member an email stating that their packaging contains no BPA. These conflicting claims raise serious doubts about the credibility of PBM’s consumer information on BPA.
Nestlé tells parents on the phone and by email that their powdered formulas have no contact with BPA. They repeatedly told EWG researchers the same thing over the phone, but failed to put their claims in writing, making it difficult to determine if Nestlé is really a better option for babies.
Ross-Abbot, the makers of Similac, is the only company that told us they tested for BPA in their products, and that they detected none. However, both EWG and the Food and Drug Administration have found BPA in Similac cans, raising questions about either Ross-Abbot’s candor or the sensitivity of their testing methods.
Guide to Baby-Safe Bottles & Formula
Breast milk is best, but whether you’re feeding breastmilk or formula in a bottle, use this guide to feed your baby safely. Read this report's press release or go to study findings.
Nipple: Start with a clear silicone nipple.
Latex rubber nipples can cause allergic reactions and can contain impurities linked to cancer.
FORMULA BUYING GUIDE
1. Your first choice should be powdered formula in a can with as little metal as possible, such as the brands in this order:
BETTER Nestlé, Enfamil & Similac powdered
(BPA in top and bottom of can)
GOOD Earth’s Best & Bright Beginnings powdered
(BPA in entire can)
2. Second choice: concentrated liquid formulas
3. Avoid all ready-to-eat liquid formulas in metal cans
Heating: Warm bottles in a pan of hot water.
Microwaving can heat unevenly and cause chemicals to leach from plastic bottles into formula.
Details
More details for bottle-feeding parents:
Breastfeed whenever possible!
Breast milk is the best source of nutrition for babies, and contains essential fatty acids that help bolster babies' bodies against the impacts of toxic chemicals. However, there are many reasons why families rely on formula for some or all of their baby’s diet. Most babies in the US receive some formula during their first year of life, with 70 percent of babies receiving some formula by 3 months of age (CDC 2007). These babies need a safe and healthy source of food, and formula should be manufactured in a way that avoids contamination with hormone disrupting chemicals.
Formula-feeding
Powdered formulas are the best choice for parents who want to avoid bisphenol A in their baby's diet. While powdered formula has not been tested for BPA, it is diluted with much more water than liquid formulas which reduces the amount of BPA that the baby consumes in each feeding. Nestlé has made unsubstantiated claims that they don't use any BPA to line their powdered formula cans. Nestlé, Enfamil and Similac use a mixed metal and cardboard package with less BPA-coating. Second best are Earth's Best Organic and PBM's store-brand powdered formulas that use a fully metal can.
Some liquid formulas are sold in plastic, mostly polyethylene and polypropylene which do not contain any BPA. Avoid any plastic containers that are rigid and transparent, marked with "PC". All liquid formulas sold in metal cans are lined with BPA-epoxy, which has been shown to leach into the product. If you buy formula in metal cans choose the concentrated type which is diluted with water prior to feeding. Avoid ready-to-eat formula in metal cans, which has the highest BPA leaching potential.
Bottle Nipples
Choose bottle nipples made from silicon. They are the most durable and inert options. Latex rubber nipples can cause allergic reactions and can contain impurities linked to cancer (Freishtat 2002; Westin 1990). The same goes for pacifiers. Throw away any nipple or pacifier that is discolored, thinning, tacky or ripped.
Bottles
There has been a lot of attention recently about BPA leaching from baby bottles and sippy cups. It appears, however, that babies fed liquid formula could have much more intense exposure to BPA from the formula itself. Even so, parents should still choose bottles that don't leach any BPA. Glass bottles are an excellent choice. More manufacturers are also making bottles and sippy cups out of safe plastics which are polyethylene, polypropylene or polyamide. Avoid all polycarbonate which are transparent (either clear or tinted) and rigid or inflexible plastic. These bottles may be marked with the letters “PC.” Polycarbonate plastics are sometimes marked with the recycling #7, which is a miscellaneous category, so not all #7 plastics are harmful.
Your pediatrician may recommend plastic bottle liners if your baby is colicky. If not, avoid using them - the manufacture and disposal of plastic liners raise environmental concerns. And never overheat formula in a plastic liner. The soft plastic liners may leach chemicals into formula, especially
when heated.
What type of water?
If your water is fluoridated, use a reverse osmosis (RO) filter to remove fluoride, which the American Dental Association recommends avoiding when reconstituting formula (ADA 2006). If your water is not fluoridated, use a carbon filter, either a pitcher-style or one that attaches to your tap. If you choose bottled water make sure it's fluoride-free. Be aware that the cost of bottled water may add up to more money than a home reverse osmosis system.
Expressing breast milk
Medela breast pump tubes, shields, and jars are BPA and phthalate free. This is important as pump parts withstand repeated washings in hot water.
Cleaning and sterilizing
Bottles, nipples, pacifiers, breast shields, pump tubing and containers should be sterilized before first use. After that, washing with hot soapy water or the top shelf of the dishwasher should be sufficient. Avoid sterilizing in the microwave or frequent use of boiling water since both will speed the breakdown of the plastic.
Warming a bottle
Warm bottles of formula or breast milk in a bowl of hot water. Do not microwave them or place them in boiling water. In addition to creating a hazard for baby, these extreme heats weather the plastics.
Take action!
Tell Your Formula Company to Remove BPA
Formula Company Contact Info
Click the email address of your formula company below, scroll down to the bottom of the list, and copy and paste the Sample Email (remember to add your name!). Also use the Sample Email for companies with online forms instead of email addresses.
Baby Basics / Bright Beginnings / Parent’s Choice and other store brands (Target, Kroger, Albertsons, Safeway)
info@brightbeginnings.com
Earth's Best
consumerrelations@Hain-Celestial.com
Enfamil
EnfamilResourceCenter@Enfamil.com
Isomil (online form only)
http://rpdmail.com/?site=WAC_CU
Nestle Good Start or Mam (online form only)
http://www.verybestbaby.com/Public/ContactUs.aspx
ProSobee
EnfamilResourceCenter@Enfamil.com
Safeway
info@brightbeginnings.com
Similac (online form only)
http://rpdmail.com/?site=WAC_CU
Don't see your generic or store brand? Contact Bright Beginnings, the company that produces many generic and stores brands.
info@brightbeginnings.com
Sample Email
I recently learned that your company uses a hormone-disrupting chemical called bisphenol A (BPA) as a lining for the metal portions of your baby formulas. Environmental Working Group and FDA tests show that the chemical leaches into the formula and could subject babies to harmful exposures. In fact, EWG calculated that 1 in 16 children fed ready-to-eat formula from steel cans would have BPA exposures that exceed doses found harmful in animal studies.
Two separate panels sponsored by the National Institutes of Health (NIH) have expressed concerns about infant exposure to BPA. The Center for the Evaluation of Risks to Human Reproduction (CERHR) concluded that infant exposure could harm brain development and adversely affect behavior. The chairman of the CERHR panel indicted that “it might be a time for application of the precautionary principle” for BPA, suggesting that parents would be wise to avoid infant exposure to the chemical until serious outstanding questions about BPA’s potential harm are sorted out.
The second NIH panel of 38 BPA experts expressed grave concerns that human exposures are at or above the levels that cause harm in animal studies.
As a consumer of your product and concerned parent I want to know if your formula is contaminated with BPA, and at what levels. I urge you to provide consumers with infant formulas that are free of this toxic chemical.
Sincerely,
Powdered is better
BPA has been detected in every brand of liquid formula, but powdered formulas have not yet been tested. While most formula containers produced in the United States contain some BPA in the lining, we found significant differences in BPA leaching potential of liquid and powdered formulas. Our modeling suggests that powdered formulas are a better choice for babies.
We modeled three factors that determine BPA leaching potential from different types of formula containers and concluded that liquid formulas have 8 to 20 times higher potential BPA leaching than the most common powdered formulas due to smaller can sizes and the fact that the product is less diluted with water.
Even if the same amount of BPA leached from coated metals in powdered and liquid formulas, babies fed powdered formula will receive less BPA than those fed liquid formula from metal cans
Four factors govern the amount of BPA leaching from different types of formula in metal cans:
* The amount of surface area coated with BPA. Enfamil and Similac use BPA on the metal top and bottom lids of their package, approximately 30% of the container. Earth’s Best Organic, PBM/Store Brands and all liquid formula use cans with 100% BPA lining. Nestlé claims to use no BPA in their packaging but it is unclear what they use instead.
* The volume of the container. Smaller containers have a higher surface-to-volume ratio which results in potentially higher concentrations of BPA in the product than larger containers.
* How much the product is diluted with water. For powdered formula, parents mix about 34 grams of powdered formula with 8 ounces (226 grams) of water, meaning about 13% of the bottle contents came from the can. For concentrated liquid formula, parents mix with an equal amount of water, diluting the contents of the can by 50%. Ready-to-eat formulas are not diluted with any water.
* The heat intensity of the canning process. Studies measuring BPA levels in liquid formula find that the actual amount of BPA is variable, probably due to differences in the can and the processing. Since there is no available information on the BPA content of powdered formulas, we assumed that BPA is equally likely to leach from the plastic surfaces of a powdered or liquid formula can.
Our calculations also assume that parents are using bottles that don't leach any BPA into formula.
Using Enfamil and Similac cans with 30% BPA coating as the baseline we found that 100% metal cans of powdered formula (used by Earth's Best and PBM) have 3 or 4 times higher leaching potential depending on the can size. But the real difference is comparing the leaching potential of liquid and powdered formulas. The maximum leaching potential was from ready-to-eat formula in smaller 8 oz. cans. These types have the highest BPA contact per unit surface area and are not diluted with any water prior to feeding. These formulas have an estimated 21-times more BPA leaching than the most popular types of powdered formulas.
Provided that BPA leaches equally from liquid and powdered formulas during processing, powdered formulas are a better option for babies. Parents should also be advised to buy formula in the largest size available and to choose concentrated rather than ready-to-eat liquid formulas.
Type of formula and container Brands Typical container size BPA coated surfaces Amount of formula once diluted with water Relative BPA leaching potential
Powdered, cardboard-metal can Similac, Enfamil 24 oz 30% 13% 1**
Powdered, full metal can PBM 25 oz 100% 13% 3
Powdered, full metal can Earth’s Best 13 oz 100% 13% 4
Liquid concentrated Various 13 oz 100% 50% 8
Liquid ready-to-eat, large can Various 33 oz 100% Not diluted 13
Liquid ready-to-eat, small can Various 8 oz 100% Not diluted 21
**This formula was used as a baseline when comparing the potential BPA leaching from other types
BPA in baby bottles
There has been justifiable concern recently about BPA leaching from baby bottles into the baby’s formula. The available data indicate, however, that liquid formulas may be a more potent source of infant exposure to BPA.
BPA has been detected in 16 of 20 liquid formula samples tested by FDA and EWG. Concentrations range from less than 1 part per billion (ppb) to 17 ppb in these samples, with an average of 5 ppb (EWG 2007a; Biles 1997). Although the data from the FDA are now 10 years old, EWG found no information indicating that formula containers has changed significantly since then, and our recent testing finds quite similar results.
Baby bottles have been more extensively tested. We found 11 studies testing BPA leaching out of polycarbonate baby bottles, reviewed by the EU Food Safety Authority or NIH review panel (EFSA 2006; CERHR 2007b) and 1 test from an advocacy group (Environment California 2007). Baby bottle tests were often designed to measure the amount of BPA that leaches out over many washing cycles. As a result, most use water heated to 100 to 200 degrees, much hotter than any liquid fed to real babies. Thus the concentrations of BPA measured reflect aggregate exposures over time, not the amount of BPA that would be released in a typical feeding.
Three tests using water between 78 and 104 degrees found no detectable BPA in bottles. Nine tests using 122 to 212 degree water found varying amounts of BPA. Of these half measured BPA levels lower than the concentrations in liquid formula, and half had higher BPA. However, since these tests reflect BPA leaching out of bottles over many wash cycles and not necessarily in liquids fed to babies, we conclude that liquid formulas present a more direct risk of BPA exposure.
BPA leaching from baby bottles filled with 78 to 176 degree water is less intense than everyday exposures from liquid formula
Test Conditions BPA concentration in tested liquids Source
Liquid baby formula in metal cans
6 liquid formula samples Avg 5.3 ppb, max 17 ppb EWG 2007a
14 liquid formula samples Avg 5 ppb, max 13 ppb FDA 1997
Bottle tests at 78 to 176 degrees
78 F for 5 hours ND (<2 ppb) Hanai 1997
78 F for 72 hours ND (<5 ppb) FDA 1996
104 F for 24 hours ND (<2 to 5 ppb) FCPSA 2005
122 F ND (<10 ppb) in water or vinegar, high levels in bottles 95% ethanol. Simouneau 2000
158 F for 1 hour, water and acetic acid ND (<1) to 5.1 ppb CSL 2004
176 F for 30 seconds or 2 mins 1.1-2.5 ppb D'Antuono 2001
176 F for 24 hours 4 to 10 ppb, avg 7 ppb Environment California 2007
Bottles tested with >200 degree water
203 F for 30 mins ND (<0.5) to 0.75 ppb Sun 2000
203 F for 30 mins ND (<0.05) to 3.9 ppb Miyamoto 2006
212 F for 30 mins, then held 72 hours ND (<5 ppb) FDA 1996
212 F for 1 hour 0.11 to 17 ppb, Avg 7 ppb in bottles washed 50+ times prior to test Brede 2003
212 F then cool 3 to 55 ppb Hanai 1997
212 F then cool, reheat to 40 C ND (<10) to 50 ppb Earls 2000
ND = not detected, value in parentheses is the detection limit.
BPA in formula--how harmful?
Each company we contacted was quick to point out that they comply with all relevant health guidelines regarding formula packaging. It’s true. Unfortunately, the standards and guidelines of the FDA and the Environmental Protection Agency are outdated and inadequate in light of growing scientific concerns about the potential harm to infants from BPA exposure.
This year, 2 separate panels from the National Institutes of Health (NIH) have expressed concerns about infant exposure to BPA. The Center for the Evaluation of Risks to Human Reproduction (CERHR) concluded that there was “some concern” that infant exposure could harm brain development and adversely affect behavior (CERHR 2007b). The chairman of the CERHR panel indicated that “it might be a time for application of the precautionary principle” for BPA, suggesting that parents would be wise to avoid all infant exposure to the chemical until serious outstanding questions about BPA’s potential harm are sorted out (Hileman 2007).
More grave concerns were expressed by a BPA expert committee convened by the National Institute of Environmental Health Sciences, a division of NIH. A consensus statement prepared by the committee concluded that the majority of current human exposures are at or above the levels that cause harm in repeated animal studies (vom Saal 2007).
Very little is known about BPA concentrations in infant formula. EWG and FDA have both tested liquid formulas. EWG tested 6 and FDA tested 14 samples (Biles 1997, EWG 2007a). Both studies found on average 5 parts per billion of BPA, and 4 samples with more than 10 ppb. At these concentrations, lighter and hungrier babies will exceed the daily doses of BPA that have been found harmful by the most sensitive laboratory studies. Most other children have an unacceptably low margin of safety between their daily exposures and the doses that are harmful in the laboratory. Because it is very likely that some people are more sensitive to BPA, or less efficient at eliminating it from their systems, it is vital that tougher regulations are put into place to reduce BPA exposures to levels many times below those found harmful in the lab.
Powdered formula samples in the U.S. have not been tested for BPA leaching. One study in Taiwan examined BPA in three powdered soy formula samples and four ‘follow-up’ formulas which are intended for older children (Kuo 2004). They detected BPA in every sample, at concentrations higher than those found in liquid formulas tested in the United States. Tests of U.S. powdered formulas are sorely needed.
Dozens of recent studies link very low concentrations of BPA with permanent alterations of the reproductive system, brain and behavior of laboratory animals (Maffini 2006). However, FDA regulations governing BPA leaching from food containers are completely out of touch with these findings of low dose toxicity. Regulations mandate that leaching of BPA into food must not exceed 0.05 milligrams of BPA from each square inch of the can surface (FDA 2006). At the maximum allowable BPA leaching, this would result in 0.5 to 5 parts per million of BPA in standard size formula cans, and lead an average 0 to 4 month old baby to exceed EPA’s outdated safe daily dose of BPA by up to 30 times (EPA 1998).
How much is safe?
Every manufacturer we contacted also assured us that there is no evidence that babies fed from BPA lined food cans and polycarbonate bottles are harmed. This also is true because no one has looked for these effects and because the potential health impacts of BPA exposure would occur later in life, and would not likely be traced back to BPA exposures during pregnancy and early life. BPA’s impacts include insulin resistance, brain and behavioral impacts, early puberty, altered hormone levels, and other reproductive problems--conditions that occur years or decades after babies are weaned from formula.
The very low concentrations of BPA found in formula put babies at unacceptable risks of harm to their brain and nervous system, and reproductive systems. Exposure to BPA in animal studies has been linked to a number of adverse health effects at incredibly low doses. The most sensitive studies find oral BPA exposures to lab animals of about 2 micrograms per kilogram of body weight per day caused increased prostate weight in animals exposed during pregnancy, (Nagel 1997), increased aggression at eight weeks of life (Kawai 2003), signs of early puberty (Howdeshell 1999), lower body weight (Honma 2002), decline in testicular testosterone (Akingbemi 2004), and cause breast cells to be predisposed to cancer in later life (Murray 2007).
Laboratory studies consistently show that the most sensitive periods of exposure to BPA are during pregnancy and early life (Maffini 2006). BPA has also been found in American mothers’ breast milk, amniotic fluid, and cord blood, indicating widespread exposure before birth (CERHR 2007b). A recent finding by the Centers for Disease Control found detectable BPA in more than 90% of 2,500 people sampled (Calafat 2007). The study didn’t include any children younger than 6, so much less is known about current exposures for newborns and babies.
EWG’s modeling, using real-life formula sampling and a survey of baby weight and formula intake, found that one of every 16 infants exclusively fed ready-to-eat canned formula would be exposed to BPA at doses exceeding those that altered testosterone levels, affected neurodevelopment, and caused other permanent harm to male and female reproductive systems (EWG 2007b). At the highest BPA levels found in formula, 17 parts per billion (ppb), nearly 2/3rds of all infants fed ready-to-eat formula would be exposed above doses that proved harmful in animal tests (EWG 2007b).
Earlier this year, the National Institutes of Health’s Center for the Evaluation of Risks to Human Reproduction (CERHR) program led an assessment of the safety of BPA. It was a highly contentious process. During the review NIH fired the CERHR contractor, Sciences International, for potential conflicts of interest including their contracts to work for companies who manufacture BPA (Bucher 2007). The draft scientific review document considered by the panel was riddled with hundreds of errors and omissions and received sharp criticism from BPA researchers (CERHR 2006). The CERHR panel dismissed evidence that BPA impacted breast and prostate development, and linking the chemical to infertility and early puberty. Nevertheless the panel did find that there was "some concern" for BPA's impact to brain and behavior for infants and children (CERHR 2007b). In the meantime, an alternative group of 38 BPA researchers and experts published a parallel review with conclusions that diverged sharply from CERHR, determining that that BPA presents a clear risk to human health (vom Saal 2007).
Much of the controversy arises over the interpretation of dozens of studies showing BPA affecting the reproductive problems and cancer at low doses. Several reviews have dismissed studies showing low-dose toxicity (EFSA 2006; CERHR 2007b). However the 38 BPA experts came to a different conclusion:
“Importantly, much evidence suggests that these adverse effects are occurring in animals within the range of exposure to BPA of the typical human living in a developed country, where virtually everyone is exposed to measurable blood, tissue and urine levels of BPA that exceed the levels produced by doses used in the low dose animal experiments" (vom Saal 2007).
Study methods & findings
On July 31, 2007, EWG sent letters to every major formula manufacturer to inquire about their use of BPA in formula packaging and product testing. The only company who responded makes a toddler formula, intended for children older than 1 year, none of the infant formula makers responded.
In October we launched a formal inquiry into the use of BPA in formula. EWG staff contacted the 4 major formula producers--Enfamil, Nestlé, Similac and PBM--as well as the leading manufacturer of organic formula Earth’s Best Organic.
We contacted each company a minimum of 3 times, and asked company representatives a series of questions about BPA: 1) whether BPA was used in liquid and powdered formula containers; 2) whether the company had performed any analysis of BPA leaching into formula; 3) what their testing found; and 4) whether they would disclose test results to EWG. Contacts included at least 2 phone calls in which we documented all responses and at least 1 email inquiry to confirm that the information they provided parents was in synch with the information they provided environmental researchers.
We found that all liquid formulas in metal cans are lined with a BPA-based plastic epoxy. Most powdered formulas contain some BPA-based lining, but the content ranges from 30 to 100% of the can surface.
Here are the company's answers to our interviewer's questions:
* Nestlé (Good Start and Mam)
* Ross-Abbot (Similac, Isomilk, Alimentum, NeoSure)
* MeadJohnson (Enfamil, ProSobee, Latofree, and Nutramigen)
* Earth's Best Organic
* Store Brand formulas (Baby Basics, Bright Beginnings, Parent's Choice and others)
Nestlé uses a BPA-based plastic to line metal cans that hold liquid formula. They claim not to use any BPA in their powdered formula containers which, if true, would make them the only manufacturer to sell a baby formula with no risk of BPA-leaching. However, they would not provide EWG with a written statement to support this claim. Also, questions on the company’s ethical practices cause EWG to have concerns about recommending their product.
Company Nestlé
Brands Good Start, Mam
Dates contacted 9/21/07 9:38 a.m. (PDT), 10/4/07 11:15 a.m., 10/18/07 10:00 a.m. (EDT)
Phone number 1/800 284-9488
Company
representative(s) Name(s) withheld for privacy
BPA in cans of liquid formula? Yes, liquid formulas sold in metal cans.
BPA in packages of powder formula? No
Test for BPA? No
Disclose results? N/A
FDA test results for liquid samples? BPA detected in 3 of 3 samples of liquid formula
EWG test results for liquid samples? None tested
Notes Nestle is the target of an international boycott for using unethical practices to market formula in the developing world (Aguayo 2003).
Ross-Abbot uses a BPA-based plastic to line metal in their liquid cans and the metal lid and bottom of their powdered containers. They are the only company that reported periodic testing for BPA in their products, and claim that their tests do not detect any leaching. They would not give EWG test results or a description of their test methods. Both EWG and FDA tests have detect BPA in their liquid formulas which gives reason to question Ross-Abbot’s testing methods.
Company Ross-Abbot
Brands Similac, Isomil, Alimentum, NeoSure
Dates contacted 9/20/07 12:15 p.m. (PDT), 10/03/07, 4:24 p.m. (EDT)
Phone number 1/800-227-5767
Company
representative(s) Name(s) withheld for privacy
BPA in cans of liquid formula? Yes, liquid formulas sold in metal cans.
BPA in packages of powder formula? Yes, top and bottom lid of powdered containers
Test for BPA? Yes, "periodic testing detects no BPA"
Disclose results? Would not disclose test results to EWG.
FDA test results for liquid samples? BPA detected in 4 of 4 samples of liquid formula
EWG test results for liquid samples? BPA detected in 1 of 3 tests of liquid formula
Notes Given that FDA & EWG tests found BPA in cans of Similac, Ross-Abbot’s testing techniques may not be sensitive enough. Ross-Abbot also sells concentrated liquid formula in plastic containers that contain no BPA.
MeadJohnson uses a BPA-based plastic in their liquid formula packaging and in the top and bottom lids of their powdered formula containers. They do not perform tests to detect BPA in their products.
Company MeadJohnson
Brands Enfamil, Lactofree, Nutramigen, ProSobee
Dates contacted 9/20/07 12:30 p.m. (PDT) 10/03/07, 4:45 p.m. (EDT)
Phone number 1/800-222-9123
Company
representative(s) Name(s) withheld for privacy
BPA in cans of liquid formula? Yes, liquid formulas sold in metal cans. Also used to line the lids of glass or plastic bottles.
BPA in packages of powder formula? Yes, top and bottom lid of powdered containers
Test for BPA? No
Disclose results? N/A
FDA test results for liquid samples? BPA detected in 3 of 3 cans of liquid formula
EWG test results for liquid samples? BPA detected in 1 of 3 cans of liquid formula
Hain-Celestial only sells powdered formula in a fully metal can, which uses a BPA-based plastic in the entire can lining. They do not test their product for BPA leaching.
Company Hain-Celestial
Brands Earth’s Best Organic
Dates contacted 9/20/07 12:50pm (PDT), multiple email attempts
Phone number 1/800-434-4246
Company
representative(s) Name(s) withheld for privacy
BPA in cans of liquid formula? NA. The company sells only powdered formula
BPA in packages of powder formula? Yes
Test for BPA? No
Disclose results? N/A
FDA test results for liquid samples? N/A
EWG test results for liquid samples? N/A
Notes No one has tested Earth's Best formulas or any other powdered formulas sold in the U.S. for BPA
PBM manufactures infant formula for store brands and private labels. They uses a BPA-based lining on their metal cans for liquid and powder formula. EWG received copies of 2 emails PBM sent parents claiming that their product is BPA-free.
Company PBM, maker of store brand formulas
Brands Baby Basics, Babymil, Bright Beginnings, Comforts, CVS, Eckerd, Good Sense, Hill Country Fare, Home Best, Kozy Kids, Little Ones, Meijer, Nanny’s, Parent’s Choice, Perfect Choice, Shop Rite, Target, Top Care, Walgreens, Wegmans, Western Family.
Dates contacted 10/05/07, 4:00 p.m., 10/10/07 1:10 p.m., 10/12/07 1:20 p.m., 10/12/07 4:20 p.m. (EDT)
Phone number 1/800-272-5095
Company
representative(s) Name(s) withheld for privacy
BPA in cans of liquid formula? Yes, liquid formulas sold in metal cans.
BPA in packages of powder formula? Yes
Test for BPA? No
Disclose results? N/A
FDA test results for liquid samples? BPA detected in 3 of 3 cans of liquid formula
EWG test results for liquid samples? None tested
Notes PBM gave conflicting answers to queries about its use of BPA. They told EWG researchers that their packaging contained BPA, but 2 emails to parents say that the company does not use it.
References
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Aguayo VM, Ross JS, Kanon S, Ouedraogo AN. 2003. Monitoring compliance with International Code of Marketing of Breastmilk Substitutes in west Africa: multisite cross sectional survey in Togo and Burkina Faso. BMJ 326(127): 6.
Akingbemi BT, Sottas CM, Koulova AI, Klinefelter GR, Hardy MP. 2004. Inhibition of testicular steroidogenesis by the xenoestrogen bisphenol A is associated with reduced pituitary luteinizing hormone secretion and decreased steroidogenic enzyme gene expression in rat Leydig cells. Endocrinology 145(2): 592-603.
Biles JE, McNeal TP, Begley TH. 1997. FDA-Determination of bisphenol A migrating from epoxy can coatings to infant formula liquid concentrates. J Agric Food Chem 45: 4697-700.
Brede C, Fjeldal P, Skjevrak I, Herikstad H. 2003. Increased migration levels of bisphenol A from polycarbonate baby bottles after dishwashing, boiling and brushing. Food Addit Contam 20(7): 684-9.
Bucher J. 2007. Meeting Presentation: CERHR Second Expert Panel Meeting on Bisphenol A. August 6-8, 2007: NIEHS-National Toxicology Program. Alexandria, VA.
Calafat AM, Ye, X., Wong, LY, Reidy JA, Needham LL. 2007. Exposure of the U.S. Population to Bisphenol A and 4-tertiary-Octylphenol: 2003-2004. Environ Health Perspect, Advanced publication, Online 24 October 2007.
CDC. 2007. Breastfeeding Report Card, United States — 2007: Outcome Indicators. Available: http://www.cdc.gov/breastfeeding/data/report_card2.htm [accessed 11/12/07 2007].
CERHR. 2007a. 2nd DRAFT NTP-CERHR report on the Reproductive and Developmental Toxicity of Bisphenol A. Interim Draft. Research Triangle Park, NC: National Toxicology Program-Center for Evaluation for Risks to Human Reproduction. April 2007. Public comments: http://cerhr.niehs.nih.gov/chemicals/bisphenol/pubcomm-bisphenol.html
CERHR. 2007b. NTP-CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Bisphenol A. Research Triangle Park, NC: National Toxicology Program-Center for Evaluation for Risks to Human Reproduction. November 26, 2007. http://cerhr.niehs.nih.gov/chemicals/bisphenol/BPAFinalEPVF112607.pdf
CSL. 2004. A study of the migration of bisphenol A from polycarbonate feeding bottles into food simulants. Central Science Laboratory Test Report, L6BB-1008.
D'Antuono A, Dall'Orto VC, Lo Balbo A, Sobral S, Rezzano I. 2001. Determination of bisphenol A in food-simulating liquids using LCED with a chemically modified electrode. J Agric Food Chem 4: 1098-2101.
Earls AO, Clay CA, Braybrook JH. 2000. Preliminary investigation into the migration of bisphenol A from commercially-available polycarbonate baby feeding bottles. Final Report prepared by LGC Consumer Safety Team for the Consumer Affairs Directorate, Department of Trade and Industry. Technical Report LGC/DTI/2000/005.
EFSA. 2006. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to 2,2-Bis(4-Hydroxyphenyl)Propane (Bisphenol A). European Food Safety Authority. Question number EFSA-Q-2005-100. November 29, 2006.
Environment California, Gibson R. 2007. Toxic Baby Bottles--Scientific study finds leaching chemicals in clear plastic baby bottles. Available: http://www.environmentcalifornia.org/environmental-health/stop-toxic-toy... [accessed Access 2007].
EPA. 1998. Integrated Risk Information System. Oral RfD Assessment: Bisphenol A. U.S. Environmental Protection Agency. Washington, DC.
EWG. 2007a. Toxic Plastics Chemical in Infant Formula. Environmental Working Group, Washington DC. Available: http://www.ewg.org/reports/bpaformula [accessed 2007].
EWG. 2007b. Bisphenol A: Toxic Plastics Chemical in Canned Food. Environmental Working Group, Washington DC. Available: http://www.ewg.org/reports/bisphenola [accessed 2007].
FCPSA. 2005. Migration of bisphenol A and plasticizers from plastic feeding utensils for babies. Food and Consumer Product Safety Authority, Report no. ND05o410.
FDA. 1984. Sec. 500.450 Volatile N-Nitrosamines in Rubber Baby Bottle Nipples (CPG 7117.11). Food and Drug Administration.
FDA. 1996. Cumulative Exposure Estimated for Bisphenol A (BPA), Individually for Adults and Infants from Its Use in Epoxy-Based Can Coatings and Polycarbonate (PC) Articles Branch, HFS-245. (letter to G. Diachenki, Ph.D, Division of Product Manufacture and Use, HGS-245.)
FDA. 2006. Indirect food additives: Adhesives and components of coatings, 175.380 Xylene-formaldehyde resins condensed with 4,4'-isopropylidenediphenol-epichlorohydrin epoxy resins. 21CFR175.380, Revised April 1, 2006. Food and Drug Administration, 194-95.
Freishtat RJ, Goepp JG. 2002. Episodic stridor with latex nipple use in a 2-month-old infant. Ann Emerg Med 39(4): 441-3.
Hileman B. 2007. Bisphenol A Vexations--Two government-convened panels reach nearly opposite conclusions on compound's health risks. Chemical & Engineering News 85(36): 31-33.
Honma S, Suzuki, A., Buchanan, D.L., Katsu, Y., Watanabe, H., Iguchi, T. 2002. Low dose effect of in utero exposure to bisphenol A and diethylstilbestrol on female mouse reproduction. Reprod Toxicol 16(2): 117-22.
Howdeshell KL, Hotchkiss AK, Thayer KA, Vandenbergh JG, vom Saal FS. 1999. Exposure to bisphenol A advances puberty. Nature 401(6755): 763-4.
Kawai K, Nozaki T, Nishikata H, Aou S, Takii M, Kubo C. 2003. Aggressive behavior and serum testosterone concentration during the maturation process of male mice: the effects of fetal exposure to bisphenol A. Environ Health Perspect 111(2): 175-8.
Kuo HW, Ding WH. 2004. Trace determination of bisphenol A and phytoestrogens in infant formula powders by gas chromatography-mass spectrometry. J Chromatogr A 1027(1-2): 67-74.
Maffini MV, Rubin BS, Sonnenschein C, Soto AM. 2006. Endocrine disruptors and reproductive health: the case of bisphenol-A. Mol Cell Endocrinol 254-255: 8.
Murray TJ, Maffini MV, Ucci AA, Sonnenschein C, Soto AM. 2007. Induction of mammary gland ductal hyperplasias and carcinoma in situ following fetal bisphenol A exposure. Reprod Toxicol 23(3): 383-90.
Nagel SC, vom Saal FS, Welshons WV. 1999. Developmental effects of estrogenic chemicals are predicted by an in vitro assay incorporating modification of cell uptake by serum. J Steroid Biochem Mol Biol 69(1-6): 343-57.
Simoneau C, Roeder G, Anklam E. 2000. Migration of bisphenol-A from baby bottles: effect of experimental conditions and European survey. 2nd International Symposium on Food Packaging: Ensuring the Safety and Quality of Foods (ILSI conference). Vienna, Austria.
vom Saal FS, Akingbemi BT, Belcher SM, Birnbaum, LS, Crain, DA, Eriksen, M, Farabollini, F, Guillette, L.J., Hauser, R., Heindel JJ, Ho SM, Hunt PA, Iguchi T, Jobling S, Kanno J, Keri RA, Knudsen KE, Laufer H, LeBlanc GA, Marcus M, McLachlan JA, Myers JP, Nadal A, Newbold RR, Olea N, Prins GS, Richter CA, Rubin BS, Sonnenschein C, Soto AM, Talsness CE, Vandenbergh JG, Vandenberg LN, Walser-Kuntz DR, Watson CS, Welshons WV, Wetherill Y, Zoeller RT. 2007. Chapel Hill bisphenol A expert panel consensus statement: integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure. Reprod Toxicol 24(2): 131-8.
Westin JB. 1990. Ingestion of carcinogenic N-nitrosamines by infants and children. Arch Environ Health 45(6): 359-63.
BPA Levels in Canned Infant Formula Poses Higher Risk Than Baby Bottles
WASHINGTON – Many new parents are aware that the toxic chemical Bisphenol-A (BPA) leaches from plastic baby bottles found on the shelves of stores across America. But a new investigation by Environmental Working Group (EWG) reveals that BPA is also used to line nearly all infant formula cans. BPA levels found in liquid formula are likely to be far higher than those that leach from bottles under normal use.
EWG contacted company officials at Nestlé, Ross-Abbot (Similac), MeadJohnson (Enfamil), Hain-Celestial (Earth’s Best), and PBM (sold under various names at Walmart, Kroger, Target and other stores). Each company’s policy was documented a minimum of three times; twice through detailed phone interviews, and once by an e-mail questionnaire. The results reveal that all manufacturers use BPA to line the metal portions of all infant formula containers, including powdered varieties.
"Many parents have switched to BPA-free bottles for their infants. They certainly should have access to BPA-free formula as well," said Sonya Lunder, a senior analyst with EWG. “U.S. manufacturers of infant formula and baby bottles can and should do the right thing and remove this harmful chemical from their products.”
“There is mounting scientific evidence that BPA is toxic, especially to children,” said Aaron Freeman, Policy Director with Environmental Defence. “Governments should be acting quickly, starting with a ban on BPA in food and beverage containers.”
Previous formula testing by EWG and the Food and Drug Administration (FDA) has shown that BPA leaches from the plastic lining of metal cans into liquid formula, exposing formula-fed babies to potentially harmful concentrations that are higher than levels leaching from the bottles. BPA levels in powdered formula sold in the United States haven’t been tested, but this formula is diluted with water before being fed to babies, and thus poses less risk to babies.
In light of these findings, EWG has created an online guide for parents to help them make the most informed decisions about how they feed their babies.
Should Parents Be Concerned About BPA?
Two separate panels sponsored by the National Institutes of Health (NIH) have both detailed concerns within the last year about infant exposure to BPA. One of the NIH panels consisting of 38 BPA experts from around the world expressed grave concerns that human exposures are at or above the levels that cause harm in animal studies.
The other panel within NIH – The Center for the Evaluation of Risks to Human Reproduction (CERHR) - concluded that there was “some concern” that infant exposure could harm brain development and adversely affect behavior. The chairman of the CERHR panel indicted that parents would be wise to avoid infant exposure to the chemical until serious outstanding questions about BPA’s potential harm are sorted out.
EWG’s previous estimates found that BPA exposures from liquid formula add up, particularly for the smallest and hungriest babies. We found that 1 out of every 16 infants fed ready-to-eat liquid formula are exposed to BPA at doses exceeding those that caused increased aggression and significant changes in testosterone levels in laboratory animals.
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EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment.
Environmental Defence protects the environment and human health. We research. We educate. We go to court when we have to. All in order to ensure clean air, safe food and thriving ecosystems. Nationwide.
Source URL:
http://www.ewg.org/reports/infantformula
Bottle: Use glass.
Plastic bottles can leach a toxic chemical called bisphenol A (BPA)
into formula. Avoid clear, hard plastic bottles marked with a 7 or “PC.”
Plastic bottle liners: Don’t use them.
The soft plastic liners may leach chemicals into formula, especially
when heated.
Water: Use filtered tap water.
If your water is fluoridated, use a reverse osmosis filter to remove fluoride, which the American Dental Association recommends avoiding when reconstituting formula. If your water is not fluoridated use a carbon filter. If you choose bottled water make sure it’s fluoride-free.
Formula: Choose powdered.
A toxic chemical called bisphenol A (BPA) can leach from the lining of metal cans and lids. Liquid formulas have higher levels. Powdered formula is a better bet. If you're concerned about BPA, click here to tell infant formula manufacturers to remove it from their product packaging.
http://www.fda.gov/consumer/updates/fibromyalgia062107.html
Living with Fibromyalgia, Drugs Approved to Manage Pain
* Approved Drugs
* Debilitating Effects
* What Causes Fibromyalgia?
* Getting a Diagnosis
* More than Medicine
After meeting on the Internet in 1997, Lynne Matallana and Karen Lee Richards discovered they had a lot in common. They both had seen numerous doctors before being diagnosed with fibromyalgia, a chronic condition characterized by fatigue and widespread pain in muscles and joints. They both had trouble finding medical information and support for coping with the illness. Seven months after meeting, they started gathering with five other people with fibromyalgia who also wanted to bring awareness to the issue.
"We called ourselves 'the pillow posse' because we would meet and have our pillows to support our aching bodies," Matallana says. Those gatherings grew into the National Fibromyalgia Association (NFA), an organization that now provides support, research information, medical education, and messages of hope to millions.
Fibromyalgia affects 2 to 4 percent of the population, according to the American College of Rheumatology (ACR). It mostly affects women, and tends to develop in early to middle adulthood. But men and children also can have it.
"One of the challenges is that fibromyalgia hasn't always been recognized as a specific illness," says Jeffrey Siegel, M.D., clinical team leader in FDA's Division of Anesthesia, Analgesia, and Rheumatology Products. "In 1990, the American College of Rheumatology developed criteria for diagnosing it, and this marked a major step forward in helping more people understand how to recognize the symptoms and how to treat them."
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Approved Drugs
People with fibromyalgia have typically turned to pain medicines, antidepressants, muscle relaxants, and sleep medicines. In June 2007, Lyrica (pregabalin) became the first FDA-approved drug for specifically treating fibromyalgia; a year later, in June 2008, Cymbalta (duloxetine hydrochloride) became the second.
Both Lyrica and Cymbalta reduce pain and improve function in people with fibromyalgia. While those with fibromyalgia have been shown to experience pain differently from other people, the mechanism by which these drugs produce their effects is unknown. There is some data suggesting that these drugs affect the release of neurotransmitters in the brain. Neurotransmitters are chemicals that transmit signals from one neuron to another. Treatment with Lyrica or Cymbalta reduces the level of pain experienced by some people with fibromyalgia.
Lyrica, marketed by Pfizer Inc., was previously approved to treat seizures, as well as pain from damaged nerves that can happen in people with diabetes (diabetic peripheral neuropathy) and in those who develop pain following the rash of shingles. Side effects of Lyrica including sleepiness, dizziness, blurry vision, weight gain, trouble concentrating, swelling of the hands and feet, and dry mouth. Allergic reactions, although rare, can occur.
Cymbalta, marketed by Eli Lilly and Co., was previously approved to treat depression, anxiety, and diabetic peripheral neuropathy. Cymbalta's side effects include nausea, dry mouth, sleepiness, constipation, decreased appetite, and increased sweating. Like some other antidepressants, Cymbalta may increase the risk of suicidal thinking and behavior in people who take the drug for depression. Some people with fibromyalgia also experience depression.
Studies of both drugs showed that a substantial number of people with fibromyalgia received good pain relief, but there were others who didn't benefit.
Lyrica and Cymbalta are approved for use in adults 18 years and older. The drug manufacturers have agreed to study their drugs in children with fibromyalgia and in breastfeeding women.
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Debilitating Effects
Matallana, who is now president of NFA, says she was a partner in an advertising firm when her life turned completely upside down because of her symptoms. "I finally had to stop working in 1995 and spent most of the next two years in bed," she says. Her husband quit his job and became a consultant working from home so that he could care for her.
"I had a yoga instructor coming to my house three times a week to help me get out of bed. The pain and exhaustion were so bad that there were days that the only activity I was able to do was walk from my bed to the mailbox and back to bed. Each day seemed like an eternity and so I had to focus on just getting through one day at a time."
People with fibromyalgia can experience pain anywhere, but common sites of pain include the neck, shoulders, back, hips, arms, and legs. In addition to pain and fatigue, other symptoms include difficulty sleeping, morning stiffness, headaches, painful menstrual periods, tingling or numbness of hands or feet, and difficulty thinking and remembering. Some people with the condition may also experience irritable bowel syndrome, pelvic pain, restless leg syndrome, and depression.
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What Causes Fibromyalgia?
Scientists believe that the condition may be due to injury, emotional distress, or viruses that change the way the brain perceives pain, but the exact cause is unclear. People with rheumatoid arthritis, lupus, and spinal arthritis may be more likely to have the illness.
According to ACR, people with fibromyalgia can have abnormal levels of Substance P in their spinal fluid. This chemical helps transmit and amplify pain signals to and from the brain.
Researchers are looking at the role of Substance P and other neurotransmitters, and studying why people with fibromyalgia have increased sensitivity to pain and whether there is a gene or genes that make a person more likely to have it.
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Getting a Diagnosis
Matallana says she felt her suffering was being dismissed as she went from doctor to doctor looking for answers.
"Many doctors suggested that it was just stress," she says. "Some of them even made references that it was all in my head. I was eventually misdiagnosed as having lupus."
When Matallana was 39, a rheumatologist who was just starting his practice, finally diagnosed her with fibromyalgia. "With my doctor's help, I started to feel better," she says. "It made all the difference that I had a health care provider who could give me insights as to what fibromyalgia research was showing, and that there were other people feeling what I was feeling."
Family physicians, general internists, and rheumatologists are the doctors who typically treat fibromyalgia. There is no diagnostic test for it. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions. For example, fibromyalgia can be distinguished from arthritis because arthritis causes inflammation of tissues and joints and fibromyalgia does not. Another condition with similar symptoms, hypothyroidism, can be confirmed with a blood test.
Diagnostic criteria set forth by ACR include a history of widespread pain for at least three months and pain in at least 11 of 18 tender point sites.
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More than Medicine
People with fibromyalgia may find relief of symptoms with pain relievers, sleep medicines, antidepressants, muscle relaxants, and anti-seizure medications. But medication is just one part of the treatment approach.
What helped Matallana was a combination of medicines for pain and sleep, treatment for some of the overlapping conditions like migraines and irritable bowel syndrome, and a combination of water therapy, massage and yoga. Walking, jogging, biking, gently stretching muscles, and other exercises also can be helpful.
Emotional support also is essential, Matallana says. "My husband always believed me, and when you have that kind of support it makes a difference. It's really about facing chronic pain for the rest of your life. So dealing with the emotional impact and not just the physical side is very important."
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http://www.fda.gov/consumer/updates/vytorin071808.html
Making Sense of Vytorin Concerns
Q & A with Robert Temple, M.D.
Robert Temple, M.D., is Director of the Office of Medical Policy in the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research. Dr. Temple graduated from New York University School of Medicine and completed his residency in internal medicine at Columbia's College of Physicians and Surgeons in New York City. He has been with FDA for 36 years.
Q. What is Vytorin?
A. Vytorin is one tablet that combines two cholesterol-lowering drugs— simvastatin (Zocor), a statin made by Merck & Co., and ezetimibe (Zetia), made by Schering-Plough Pharmaceuticals—to help lower bad cholesterol (low-density lipoprotein, or LDL) further. Simvastatin works in the liver to prevent the formation of cholesterol (as do all statin medications), while ezetimibe works by preventing the absorption of cholesterol from the intestine.
Q. What is the ENHANCE study?
A. About four years ago, Merck and Schering-Plough began a study—Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression, or ENHANCE—that compared the effect of ezetimibe combined with simvastatin (Vytorin) to simvastatin alone. The patients in the study were people with a genetic condition of very high cholesterol called familial hypercholesterolemia. Through images taken with ultrasound, the study evaluated the thickness of the walls of the blood vessels of the neck (carotid arteries). Some studies indicate that increased thickness of the carotid artery walls is associated with an increased risk for cardiovascular disease.
ENHANCE did not try to show an effect of Vytorin on important outcomes, such as the chance of a heart attack or stroke. Rather, it was an imaging study of what is often called a biomarker—in this case, the thickness of the blood vessel walls.
Q. What were the results of the ENHANCE study?
A. While the combination drug Vytorin did better at lowering LDL cholesterol levels than treatment with simvastatin alone, the effect of Vytorin on carotid artery wall thickness was no greater than that observed with simvastatin by itself.
The results were disappointing, of course, but they do not give the answer about the value of ezetimibe. At this point we know that ezetimibe lowers cholesterol modestly (not nearly as much as a statin), but we do not have definitive evidence that it lowers the risk for cardiovascular disease. The answer to whether it does should come from a large (18,000-patient) outcome study that will examine the effect of ezetimibe added to simvastatin on cardiovascular outcomes. That study is underway but will not be completed for several years.
It is not clear why the lower levels of LDL cholesterol in patients who took Vytorin did not lead to favorable changes in carotid artery wall thickness, compared to patients treated with simvastatin alone. FDA is now reviewing the final results from the ENHANCE study.
Q. Does the Vytorin situation call into question the value of lowering cholesterol levels or the benefits of statins?
A. No. There is overwhelming evidence from many studies that people with elevated LDL cholesterol—a very well-established risk factor for heart disease—reduce their risk of a heart attack or stroke and death by lowering cholesterol with a statin. FDA's initial approval of cholesterol medications is based on a drug's ability to demonstrate successful lowering of LDL cholesterol. But every statin to date has been shown in a large outcome study to improve cardiovascular outcome, and labeling for all drugs, except for the most recently approved statin, Crestor, states this clearly. A similar finding has been reported for Crestor, but the study has not yet been reviewed by FDA.
Q. Why, then, the recent public uncertainty about the value of lowering LDL cholesterol, based on the small Vytorin study?
A. We think many people may have misunderstood both the intent and the results of ENHANCE. The study was designed to show an added benefit of ezetimibe on a biomarker and clearly failed to do so. But this does not tell you whether lower cholesterol with ezetimibe will prove useful. The results of the study were released online in the New England Journal of Medicine (NEJM) in January 2008, accompanied by news reports asking whether the results have shaken confidence in the value of lowering cholesterol, even using statins.
Although the study could perhaps lead to doubts about ezetimibe—noting again that its lack of effect was on a biomarker—it casts no doubt at all on the value of lowering cholesterol with a statin. Unfortunately, the statins, which have repeatedly been shown to give large reductions in cholesterol levels and a lower risk of dying from heart disease, were also being characterized as having uncertain benefits.
In fact, there is no basis at all for questioning the cardiovascular benefits of statins in reducing the rate of death, heart attack, and stroke in people at risk from elevated LDL cholesterol. And we are worried that some people might suddenly stop taking their statins or other preventive medicines, such as antihypertensives, either because they misunderstood news reports or are affected by a more general sense of doubt.
We already know that people tend to stop taking all long-term drugs, including statins, when they're on them. And I'm very concerned that aspects of the Vytorin discussion will lead to people becoming indifferent to an extremely important measurement—LDL cholesterol.
Q. What are the benefits of lowering your cholesterol?
A. Cholesterol is essential to the formation of certain hormones. But where LDL cholesterol levels are too high, they cause or accelerate the development of arteriosclerotic plaques (fatty deposits) in blood vessels in the heart or brain, increasing the chance of a heart attack or stroke. According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for both women and men in the United States. As mentioned, statins have been shown in numerous studies to lower the risk of heart disease and stroke. A simple blood test by your doctor will measure the different kinds of cholesterol in the body, and will allow the doctor to advise on effective treatment.
Q. What is your advice for consumers?
A. People should not misunderstand ENHANCE and think it means that elevated LDL cholesterol need not be lowered. To do so could mean significant personal and public health consequences if it drives them away from continuing to reduce their risk of heart disease through lowering their cholesterol. People should not stop taking Vytorin or any other drug containing a statin without their doctor's recommendation, even if they have concerns about the study. Patients can discuss with their doctors whether they should take a larger statin dose or add ezetimibe to control LDL cholesterol adequately. The results with statins make it overwhelmingly clear that controlling LDL cholesterol is essential.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information
Controlling Cholesterol with Statins
www.fda.gov/consumer/updates/statins051608.html
FDA Early Communication About an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)
www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm
FDA's Center for Drug Evaluation and Research
www.fda.gov/cder/
National Heart, Lung, and Blood Institute Health Information Center
www.nhlbi.nih.gov/health/infoctr/
Date Posted: July 18, 2008
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