Heart Disease Risk Factors; Food Safety for Moms To Be; FDA Alert on Tussionex; Product Advisory for Nokia branded battery

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01805.htmlFDA NewsFOR IMMEDIATE RELEASEMarch 11, 2008
FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing HydrocodoneAgency gives new safety information on proper use of Tussionex as a cough suppressantThe U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.
Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours (“extended-release”).
“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”
Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.
Highlights of the FDA’s recommendations to health care professionals include:
Tussionex should not be used (is contraindicated) in patients less than 6 years old. FDA has received reports of death in children less than 6 years of age who have been prescribed Tussionex.
Consult the prescribing information to determine the correct dose and dosing frequency of Tussionex. Tussionex is an extended-release formulation that should not be prescribed at an interval less than 12 hours.
Discuss with the patient the amount of and frequency of Tussionex to be given. Instruct patients not to take, and parents not to administer Tussionex more frequently than every 12 hours. Highlights of the FDA’s recommendations to patients include:
One of the two ingredients in this long-acting cough product is hydrocodone, a narcotic. Too much hydrocodone can cause life-threatening breathing problems and death. Call your doctor right away if you have taken this medicine and have trouble breathing, slow heartbeat, severe sleepiness or cold, clammy skin.
For Tussionex, use a medicine syringe or other device designed to measure liquid medications. A household teaspoon or tablespoon should not be used because the spoons vary in size and you may receive too much or too little of the medicine. Ask your doctor or pharmacist if you are unsure how to measure the medicine.
If the cough is not controlled despite taking the prescribed dose at the recommended interval, talk to your doctor. The manufacturer of Tussionex Pennkinetic Extended-Release Suspension (UCB Inc, Smyrna, Ga.) has agreed to update the labeling, including information that Tussionex should not be prescribed to or used in children less than 6 years of age, as well as the need for accurate dosing.
For more information and the full list of the FDA's recommendations, visit http://www.fda.gov/cder/drug/infopage/hydrocodone/default.htm
This alert does not impact short-acting cough products containing hydrocodone that can be given every 4 to 6 hours. However, the FDA is reviewing safety information on these other hydrocodone containing cough products and will provide updates as new information becomes available.
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Product Advisory for Nokia branded BL-5C battery
The following message was not seen locally by the undersigned
"http://batteryreplacement.nokia.com/batteryreplacement/en/
Dear Nokia Customer,
This is a product advisory for the Nokia-branded BL-5C battery manufactured by Matsushita Battery Industrial Co. Ltd. of Japan between December 2005 and November 2006. This product advisory does not apply to any other Nokia battery.
Nokia has identified that in very rare cases the affected batteries could potentially experience over heating initiated by a short circuit while charging, causing the battery to dislodge. Nokia is working closely with relevant local authorities to investigate this situation.
Nokia has several suppliers for BL-5C batteries that have collectively produced more than 300 million BL-5C batteries. This advisory applies only to the 46 million batteries manufactured by Matsushita between December 2005 and November 2006. There have been approximately 100 incidents of over heating reported globally. No serious injuries or property damage have been reported.
Consumers with a BL-5C battery subject to this advisory should note that all of the approximately 100 incidents have occurred while charging the battery. According to Nokia's knowledge this issue does not affect any other use of the mobile device. Concerned consumers may want to monitor a mobile device while charging that contains a BL-5C battery subject to this product advisory.
While the occurence in the BL-5C batteries produced by Matsushita in the time-period specified is very rare, for consumers wishing to do so, Nokia and Matsushita offer to replace for free any BL-5C battery subject to this product advisory.
The BL-5C batteries which are subject to the product advisory were used with the following Nokia models or separately as accessories:

Nokia 1100, Nokia 1100c, Nokia 1101, Nokia 1108, Nokia 1110, Nokia 1112, Nokia 1255, Nokia 1315, Nokia 1600, Nokia 2112, Nokia 2118, Nokia 2255, Nokia 2272, Nokia 2275, Nokia 2300, Nokia 2300c, Nokia 2310, Nokia 2355, Nokia 2600, Nokia 2610, Nokia 2610b, Nokia 2626, Nokia 3100, Nokia 3105, Nokia 3120, Nokia 3125, Nokia 6030, Nokia 6085, Nokia 6086, Nokia 6108, Nokia 6175i, Nokia 6178i, Nokia 6230, Nokia 6230i, Nokia 6270, Nokia 6600, Nokia 6620, Nokia 6630, Nokia 6631, Nokia 6670, Nokia 6680, Nokia 6681, Nokia 6682, Nokia 6820, Nokia 6822, Nokia 7610, Nokia N70, Nokia N71, Nokia N72, Nokia N91, Nokia E50, Nokia E60
This product advisory applies also to the following accessories:
Nokia Wireless GPS Module LD-1W,Nokia Wireless GPS Module LD-3W
“Nokia” and “BL-5C” are printed on the front of the battery. On the back of the battery, the Nokia mark appears at the top, and the battery identification number (consisting of 26 characters) is found at the bottom. If the battery identification number does not contain 26 characters, it is not subject to this product advisory."
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http://www.cdc.gov/HeartDisease/risk_factors.htmHeart Disease Risk FactorsSome conditions as well as some lifestyle factors can put people at a higher risk for developing heart disease. In principle, all persons can take steps to lower their risk of heart disease and heart attack by addressing these risk factors. Control of risk factors is especially need by people who already have heart disease.
Conditions Behavioral Factors Other Factors ConditionsBlood Cholesterol LevelsCholesterol is a waxy substance produced by the liver or consumed in certain foods. It is needed by the body, and the liver makes enough for the body's needs. When there is too much cholesterol in the body—because of diet and the rate at which the cholesterol is processed—it is deposited in arteries, including those of the heart. This can lead to narrowing of the arteries, heart disease, and other complications.
Some cholesterol is often termed "good," and some often termed "bad." A higher level of high–density lipoprotein cholesterol, or HDL, is considered "good," and gives some protection against heart disease. Higher levels of low–density lipoprotein, or LDL, are considered "bad" and can lead to heart disease. A lipoprotein profile can be done to measure several different forms of cholesterol, as well as triglycerides (another kind of fat) in the blood.
High Blood PressureHigh blood pressure is another major risk factor for heart disease. It is a condition where the pressure of the blood in the arteries is too high. There are often no symptoms to signal high blood pressure. Lowering blood pressure by changes in lifestyle or by medication can lower the risk of heart disease and heart attack.
Diabetes MellitusDiabetes also increases a person's risk for heart disease. With diabetes, the body either doesn't make enough insulin, can't use its own insulin as well as it should, or both. This causes sugars to build up in the blood. About three–quarters of people with diabetes die of some form of heart or blood vessel disease. For people with diabetes, it is important to work with a healthcare provider to help in managing it and controlling other risk factors.
Behavioral Factors

Tobacco Use
Tobacco use increases the risk of heart disease and heart attack. Cigarette smoking promotes atherosclerosis and increases the levels of blood clotting factors, such as fibrinogen. Also, nicotine raises blood pressure, and carbon monoxide reduces the amount of oxygen that blood can carry. Exposure to other people's smoke can increase the risk of heart disease even for nonsmokers.

Diet
Several aspects of peoples' dietary patterns have been linked to heart disease and related conditions. These include diets high in saturated fats and cholesterol, which raise blood cholesterol levels and promote atherosclerosis. High salt or sodium in the diet causes raised blood pressure levels.

Physical Inactivity
Physical inactivity is related to the development of heart disease. It also can impact other risk factors, including obesity, high blood pressure, high triglycerides, a low level of HDL (good) cholesterol, and diabetes. Regular physical activity can improve risk factor levels.

Obesity
Obesity is excess body fat. It is linked to higher LDL (bad) cholesterol and triglyceride levels and to lower HDL (good) cholesterol, high blood pressure, and diabetes.

Alcohol
Excessive alcohol use leads to an increase in blood pressure, and increases the risk for heart disease. It also increases blood levels of triglycerides which contributes to atherosclerosis.

Other Factors
HeredityHeart disease can run in the family. Genetic factors likely play some role in high blood pressure, heart disease, and other vascular conditions. However, it is also likely that people with a family history of heart disease share common environments and risk factors that increase their risk.
Page last reviewed: November 15, 2007Page last modified: November 15, 2007
Content source: Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion


http://www.cfsan.fda.gov/~pregnant/pregnant.htmlCFSAN/Office of Food Safety, Defense, and OutreachAugust 24, 2005

Food Safety for Moms-To-BeWelcome! We're glad you're here because foodborne illness is a serious health risk for pregnant women and their unborn babies. You'll find accurate, easy-to-understand information about foodborne illness. Here you'll find top line points about food safety during pregnancy. It's a great reminder of ways to keep you and your baby safe!All you need to know about food safety during pregnancy.

At-A-Glance
Before You're Pregnant
While You're Pregnant
Once Baby Arrives
Safe Eats

Highlights
Lifelong Food Safety
Resources
Educator Tools
Medical Professionals

What is foodborne illness?
It's a sickness that occurs when people eat or drink harmful microorganisms (bacteria, parasites, viruses) or chemical contaminants found in some foods or drinking water. Symptoms vary, but in general can include: stomach cramps, vomiting, diarrhea, fever, headache, or body aches. Sometimes you may not feel sick, but whether you feel sick or not, you can still pass the illness to your unborn child without even knowing it.
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Why are pregnant women at high risk? You and your growing fetus are at high risk from some foodborne illnesses because during pregnancy your immune system is weakened, which makes it harder for your body to fight off harmful foodborne microorganisms. Your unborn baby's immune system is not developed enough to fight off harmful foodborne microorganisms. For both mother and baby, foodborne illness can cause serious health problems - or even death.
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There are many bacteria that can cause foodborne illness, such as E. coli O157:H7 and Salmonella. Here are 4 Simple Steps you should follow to keep yourself and your baby healthy during pregnancy and beyond!
1. Clean Wash hands thoroughly with warm water and soap. Wash hands before and after handling food, and after using the bathroom, changing diapers, or handling pets. Wash cutting boards, dishes, utensils, and countertops with hot water and soap. Rinse raw fruits and vegetables thoroughly under running water.
2. Separate Separate raw meat, poultry, and seafood from ready-to-eat foods. If possible, use one cutting board for raw meat, poultry, and seafood and another one for fresh fruits and vegetables. Place cooked food on a clean plate. If cooked food is placed on an unwashed plate that held raw meat, poultry, or seafood, bacteria from the raw food could contaminate the cooked food.
3. Cook Cook foods thoroughly. Use a food thermometer to check the temperature. See the Apply the Heat (PDF 20.3KB - also available as JPG 44.4KB) chart for the recommended cooking times for foods. Keep foods out of the Danger Zone: The range of temperatures at which bacteria can grow - usually between 40° F and 140° F (4° C and 60° C). 2-Hour Rule: Discard foods left out at room temperature for more than two hours.
4. Chill Your refrigerator should register at 40° F (4° C) or below and the freezer at 0° F (-18° C). Place an appliance thermometer in the refrigerator, and check the temperature periodically. Refrigerate or freeze perishables (foods that can spoil or become contaminated by bacteria if left unrefrigerated). Use ready-to-eat, perishable foods (dairy, meat, poultry, seafood, produce) as soon as possible.

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3 Foodborne Risks for Pregnant WomenAs a mom-to-be, there are 3 specific foodborne risks that you need to be aware of. These risks can cause serious illness or death to you or your unborn child. Follow these steps to help ensure a healthy pregnancy.
1. Listeria What it is:A harmful bacterium that can grow at refrigerator temperatures where most other foodborne bacteria do not. It causes an illness called listeriosis.
Where it's found:Refrigerated, ready-to-eat foods and unpasteurized milk and milk products. How to prevent illness: Follow the 4 Simple Steps above. Do not eat hot dogs and luncheon meats - unless they're reheated until steaming hot. Do not eat soft cheese, such as Feta, Brie, Camembert, "blue-veined cheeses," "queso blanco," "queso fresco," and Panela - unless it's labeled as made with pasteurized milk. Check the label. Do not eat refrigerated pâtés or meat spreads. Do not eat refrigerated smoked seafood - unless it's in a cooked dish, such as a casserole. (Refrigerated smoked seafood, such as salmon, trout, whitefish, cod, tuna, or mackerel, is most often labeled as "nova-style," "lox," "kippered," "smoked," or "jerky." These types of fish are found in the refrigerator section or sold at deli counters of grocery stores and delicatessens.) Do not drink raw (unpasteurized) milk or eat foods that contain unpasteurized milk. 2. Methylmercury What it is:A metal that can be found in certain fish. At high levels, it can be harmful to an unborn baby's developing nervous system.
Where it's found:Large, long-lived fish, such as shark, tilefish, king mackerel, and swordfish. How to prevent illness: Don't eat shark, tilefish, king mackerel, and swordfish. These fish can contain high levels of methylmercury. It's okay to eat other cooked fish/seafood as long as a variety of other kinds are selected during pregnancy or while a woman is trying to become pregnant. She can eat up to 12 ounces (2 average meals) a week of a variety of fish and shellfish that are lower in mercury. Five of the most commonly eaten fish that are low in mercury are shrimp, canned light tuna, salmon, pollock, and catfish. Another commonly eaten fish, albacore ("white") tuna has more mercury than canned light tuna. So, when choosing your two meals of fish and shellfish, you may eat up to 6 ounces (one average meal) of albacore tuna per week. 3. Toxoplasma What it is:A harmful parasite. It causes an illness called toxoplasmosis that can be difficult to detect.

Where it's found:
Raw and undercooked meat; unwashed fruits and vegetables; soil; dirty cat-litter boxes; and outdoor places where cat feces can be found. How to prevent illness: Follow the 4 Simple Steps above. If possible, have someone else change the litter box. If you have to clean it, wash your hands with soap and warm water afterwards. Wear gloves when gardening or handling sand from a sandbox. Don't get a new cat while pregnant. Cook meat thoroughly: see the Apply the Heat (PDF 20.3KB - also available as JPG 44.4KB) chart for the proper temperatures.
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For More Information: See your doctor or health-care provider if you have questions about foodborne illness. FDA Food Information Line: 1-888-SAFE-FOOD. FDA Center for Food Safety and Applied Nutrition: www.cfsan.fda.gov Gateway to Government Food Safety Information: www.foodsafety.gov U.S. Partnership for Food Safety Education: www.fightbac.org
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