Advisory vs. IPixel store at the third floor of Robinsons Ermita.
On February 18, 2010, an employee, at said store, issued Sales Invoice No. 30873 where the address was not at Robinsons Ermita but at SM City San Lazaro. So, if a
customer wanted to complain regarding a product sold at IPixel at Robinsons Ermita, he/she would have to go to SM San Lazaro.

Advisory vs. Wendy's restaurant on Taft Avenue (near PGH hospital), Manila. On February 19, 2010, when I went to said restaurant, there was no visible express lane for senior citizens and no sign regarding the privileges of senior citizens, contrary to the implementing rules and regulations of the Expanded Senior Citizens Act of 2003.


Advisory vs. Chowking restaurant on Taft Avenue, corner U.N.Avenue, Manila. On February 19, 2010, when I went to said restaurant, there was no visible express lane for senior citizens and no sign regarding the privileges of senior citizens, contrary to the implementing rules and regulations of the Expanded Senior Citizens Act of 2003.



CDC Healthy Aging Topics
http://www.cdc.gov/aging/

Health Information for Older Adults
Alzheimer’s disease HIV/AIDS
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Alcohol Use Lung cancer
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Breast cancer Mental health
Cancer Motor vehicle-related injuries
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Clinical preventive services Oral health
Cholesterol Osteoporosis
Colorectal cancer Physical activity
Depression Prostate cancer
Diabetes Pneumonia vaccine
Elder abuse/neglect Sexual health
End-of-life preparedness Shingles vaccine
Epilepsy Smoking
Falls Substance abuseExternal Web Site Icon
H1N1 virus Suicide
Heart disease and stroke Tobacco use
Hearing lossExternal Web Site Icon Vision loss
High blood pressure West Nile virus



Don't Get Burned_ Stay Away From Ear Candles
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm200277.htm
On this page

* Burns and Other Risks
* Enforcement
* Concern for Children
* Reports of Injuries

A lit "candle" that can drip hot wax into your ear, usually as you lie on your side.

Sound dangerous? The Food and Drug Administration (FDA) thinks so, and is warning consumers to steer clear of products being sold as ear candles.

These "candles"—hollow cones that are about 10 inches long and made from a fabric tube soaked in beeswax, paraffin, or a mixture of the two—are being marketed as treatments for a variety of conditions. These conditions include ear wax buildup, sinus infections, hearing loss, headaches, colds, flu, and sore throats.

Marketers of ear candles claim that warmth created by the lit device produces suction that draws wax and other impurities out of the ear canal.

"Some ear candles are offered as products that purify the blood, strengthen the brain, or even 'cure' cancer," says Eric Mann, M.D., Ph.D., clinical deputy director of FDA's Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices.

He adds that some firms claim the candles are appropriate for use on children.

But FDA warns that ear candles can cause serious injuries, even when used in accordance to manufacturers' directions. "Also," says Mann, "FDA believes that there is no valid scientific evidence for any medical benefit from their use."


Burns and Other Risks

Mann says that ear candling—the procedure is also called "ear coning" and "thermal auricular therapy"—exposes the recipient to risks such as

* starting a fire
* burns to the face, ear canal, eardrum, and middle ear
* injury to the ear from dripping wax
* ears plugged by candle wax
* bleeding
* puncture of the eardrum
* delay in seeking needed medical care for underlying conditions such as sinus and ear infections, hearing loss, cancer, and temporomandibular joint (TMJ) disorders. (TMJ disorders often cause headache and painful sensations in the area of the ear, jaw, and face).

Even many promoters of ear candles warn potential users to have the procedure done by an experienced "candler," and to not use the candles on themselves.

Ear candling involves placing the candle in the outer ear, usually while the recipient lies on his or her side. It is also done with the recipient sitting upright.

Often, before being lit, the candle is placed through a hole located in the center of a plate. The plate is supposed to protect against hot wax or ash coming down the side of the device and onto the recipient.


Enforcement

FDA and the Canadian health regulatory agency Health Canada have acted against manufacturers of ear candles. These actions have included import alerts, seizures, injunctions, and warning letters. FDA import alerts identify products that are suspected of violating the law so that agency field personnel and U.S. Customs and Border Protection staff can stop these entries at the border prior to distribution in the United States.

In February 2010, FDA issued warning letters to three large manufacturers of ear candles. These firms were informed that FDA had determined that there was no agency approval or clearance, no manufacturing facility registration or device listing, and no adverse-event reporting systems in place in regard to their ear candles.

FDA will continue to take enforcement action when appropriate.


Concern for Children

Claims that ear candling is appropriate for kids have caused great concern at FDA. "Children of any age, including babies, are at increased risk for injuries and complications if they are exposed to ear candles," says Mann.

He adds that small children and infants may move while the device is being used, increasing the likelihood of wax burns and ear candle wax plugging the ear canal. "Also, their smaller ear canal size may make children more susceptible than adults to injuries from ear candles," he says.

Since FDA views ear candles as medical devices, manufacturers seeking approval to sell them must submit evidence to FDA that the products are safe and effective.


Reports of Injuries

FDA believes that injuries associated with ear candles are likely underreported, and encourages consumers and health care professionals to report such injuries to FDA's MedWatch Adverse Event Reporting program4.

Over the past decade, FDA has received reports of burns, punctured eardrums, and blockage of the ear canal which required outpatient surgery from the use of ear candles.

In its testing, Health Canada found that ear candles produce no measurable effect in the ear and have no therapeutic value.

And in a survey published in 1996, the medical journal Laryngoscope reported 13 cases of burns of the ear, seven cases of ear canal blockage due to wax, and one case of a punctured eardrum.

That study also reported that ear candles produced no measurable vacuum pressure or suction on a model of the ear, and that burning ear candles dripped candle wax onto the eardrum of test subjects and of the ear model.

This article appears on FDA's Consumer Updates page5, which features the latest on all FDA-regulated products.

Date Posted: February 18, 2010


FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm200931.htm
The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

These new requirements are based on FDA analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma. The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids. These medications improve a patient’s ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung’s airways.

The FDA will now require that the product labels reflect the following:

* The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid. Single-agent LABAs should only be used in combination with an asthma controller medication; they should not be used alone;
* LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications;
* LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
* Pediatric and adolescent patients who require a LABA in addition to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA to ensure compliance with both medications.

“Although these medicines play an important role in helping some patients control asthma symptoms, our review of the available clinical trials determined that their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary and Allergy Products in the FDA’s Center for Drug Evaluation and Research.

“The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone,” said Dianne Murphy, M.D., director of the FDA’s Office of Pediatric Therapeutics.

LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma.

The FDA will be requiring the manufacturers of LABAs to conduct additional studies to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The FDA will seek input on the design of these studies at a public advisory committee meeting in March 2010.

In addition to these actions, FDA will work with public and private partners under the agency’s ongoing Safe Use Initiative to study LABA prescribing practices.

“We will collaborate with our Safe Use partners to evaluate whether prescribing patterns adjust to the new recommendations for this class of asthma drugs. If prescribing patterns don’t adjust, we will determine the reasons and consider additional steps to support safe prescribing,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The Safe Use Initiative, launched in November, strives to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with public and private partners who are committed to safe medication use.

Advair and Serevent are marketed by Collegeville, PA-based GlaxoSmithKline.
Foradil is marketed by Lebanon, PA-based Novartis AG.
Symbicort is marketed by Wilmington, DE-based AstraZeneca.

Long-Acting Beta Agonist (LABA) Information
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm1

Safe Use Initiative
http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm2

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February 1, 2010
Mild Lung Disease Linked to Heart Function
http://www.nih.gov/researchmatters/february2010/02012010copd.htm

People with a mild form of a common lung condition—even those without symptoms—are at increased risk for heart problems, according to a new study. This is the first report that mild, often-symptomless chronic obstructive pulmonary disease (COPD) may be linked to the heart's pumping ability.

COPD is the nation's fourth leading cause of death. It affects an estimated 1 in 5 Americans over age 45, but as many as half the people who have it may not even be aware of it. The condition is strongly associated with smoking, and it often involves the destruction of lung tissue, called emphysema. COPD can bring persistent coughing, mucus production, wheezing, shortness of breath and chest tightness. Symptoms often worsen over time.

Researchers have long known that severe COPD can have harmful effects on the heart, decreasing its ability to pump blood effectively. To see if mild and even symptomless COPD might also be linked to reduced heart function, a team of scientists led by Dr. Graham Barr of Columbia University Medical Center studied 2,816 generally healthy adults ages 45 and older. About half were women. All were participants in the Multi-Ethnic Study of Atherosclerosis (MESA), a large study designed to detect early signs of heart, lung and blood diseases before symptoms appear. MESA is supported by NIH's National Heart, Lung, and Blood Institute (NHLBI).

As described in the January 21, 2010, issue of the New England Journal of Medicine, the researchers used breathing tests and imaging studies of the chest to assess the structure and function of each person's heart and lungs. None of the participants had severe COPD or heart disease, but many were found to have mild abnormalities in heart and lung function.

The scientists observed that as lung function and structure became increasingly impaired, so did the heart's ability to fill with oxygen-rich blood. The volume of blood pumped per minute also dropped as lung function declined. The link between lung and heart function was strongest in the 370 participants who were current smokers, but it was also seen in people with mild COPD who had never smoked.

The new results suggest that these changes in heart function occur much earlier than previously realized, when COPD is mild or even before symptoms appear. Because the study population was ethnically mixed and covered a broad age range of apparently healthy people, the findings may be widely applicable to the general U.S. population.

"These results raise the intriguing possibility that treating lung disease may, in the future, improve heart function," says Barr. "Further research is needed to prove whether treating mild COPD will help the heart work better."
Related Links:

* What is COPD?:
http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html
* COPD: Learn More, Breathe Better:
www.LearnAboutCOPD.org
* Breathing Problems? Learn to Recognize the Symptoms of COPD:
http://newsinhealth.nih.gov/2009/November/feature2.htm
* Emphysema:
http://www.nlm.nih.gov/medlineplus/emphysema.html
* Quit Smoking Today:
http://www.smokefree.gov/


FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199476.htm










Safety Announcement

[02-17-2010] The U.S. Food and Drug Administration (FDA) has received five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products.

Due to the potential for serious adverse events from product confusion, the maker of Maalox brand products has agreed to:

* Change the name of Maalox Total Relief to one that will not include the name "Maalox" and revise the graphics and information displayed on the front of the product container to help distinguish the active ingredients and uses of this product from the traditional Maalox antacids.
* An educational program that includes outreach to healthcare professionals and consumers to inform them about the different products sold under the Maalox brand, including how to select the appropriate Maalox brand product.
* Active safety monitoring and reporting of adverse events associated with the use of Maalox brand products.

The company expects to begin selling the renamed product in September 2010. Until that time, healthcare professionals and consumers should be aware of the following:

* Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription (OTC), but are NOT interchangeable.These products are intended to treat different medical conditions.
* Maalox Total Relief is not appropriate for individuals who want to use an antacid, especially if they have a history of gastrointestinal ulcer disease or a bleeding disorder.
* Maalox Total Relief contains the active ingredient bismuth subsalicylate and is used to treat diarrhea, upset stomach associated with nausea, heartburn, and gas due to overindulgence in food (overeating).Bismuth subsalicylate is chemically related to aspirin and may cause similar adverse effects such as bleeding. Bismuth subsalicylate has a warning statement stating that it should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder.
* Maalox Total Relief should not be used in children and teenagers if they are recovering from a viral infection. The product should also not be used in people who are taking oral anti-diabetic medications, blood thinning medications such as Coumadin (warfarin) or Plavix (clopidogrel), and non-steroidal anti-inflammatory drugs (NSAIDS) like ibuprofen and naproxen.
* The traditional Maalox liquid products including Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are well-recognized antacid drug products that contain aluminum hydroxide, magnesium hydroxide, and simethicone. Both are OTC products and are used for the relief of acid indigestion, heartburn, sour stomach, upset stomach, and pressure and bloating commonly referred to as gas.
* Maalox Total Relief should not be confused with traditional Maalox liquid antacid products.

FDA is concerned about the public health impact of medication mix-ups with products that have the same names or portions of the same name but contain different active ingredients. The agency encourages drug companies to consider the potential for name confusion when choosing OTC product names.
Additional Information for Consumers

To help avoid potentially serious health risks associated with Maalox product mix-ups, the FDA recommends that consumers:

* Check with a healthcare professional or pharmacist if they are not sure what Maalox product is right for them.
* Carefully look at the labels of all Maalox products to make sure the right product is being purchased for the right condition.
* Read the active ingredients, uses and warnings in the "Drug Facts" box prior to purchasing any Maalox product.
* Report any side effects from the use of Maalox products to the FDA MedWatch program, using the information at the bottom of this page.

Additional Information for Healthcare Professionals

* When recommending an OTC product such as Maalox, refer to the product by its full product name (for example, Maalox Total Relief, Maalox Advanced Regular Strength, or Maalox Advanced Maximum Strength) or use the active ingredient name.
* Ensure that patients know the product name and understand the uses of the product prior to purchase.
* Report adverse events or medication errors involving Maalox products, such as using the wrong product because of confusing names, to the FDA MedWatch program using the information at the bottom of this page.








Maalox Total Relief and Maalox have similar packaging, but are not interchangeable.

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Related Information

* Avoid Maalox Mix-Ups1
Read the labels carefully before buying or taking any over-the-counter products.

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Links on this page:

1. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm199331.htm
2. http://www.fda.govhttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
3. http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf

Page Last Updated: 02/18/2010
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Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
http://us.mc343.mail.yahoo.com/mc/welcome?.gx=1&.tm=1266552979&.rand=081bsnlvs9pqn#_pg=showMessage&sMid=2&&filterBy=&.rand=1265195446&midIndex=2&mid=1_26984651_AIWyo0IAAR%2BrS32v%2FwxgCARCo3o&m=1_26986114_AIiyo0IAAIjvS32zQQjLC2fBrAI,1_26985324_AIWyo0IAAS8YS32xFg24FSVx81E,1_26984651_AIWyo0IAAR%2BrS32v%2FwxgCARCo3o,1_26987613_AIayo0IAAAd%2FS327mAZNkmz1H3c,1_26984054_AIqyo0IAAKCcS32tEghg7Xj9JhQ,1_26983272_AIqyo0IAAIN3S32pYg0GA0GrjvA,1_26982561_AIuyo0IAAER3S32o2AGZZCCCrls,1_26980246_AIqyo0IAABDgS32ePwCXXA%2Biep4,&sort=date&order=down&startMid=0&hash=5ff733ae35dfad9a8f327488fda85148&.jsrand=5162769
Audience: Asthma management healthcare professionals, patients

FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all LABAs. The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.

Healthcare professionals are reminded that to ensure the safe use of these products:

* Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
* LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
* LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
* Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs.

Read the complete MedWatch 2010 Safety summary, including links to the Drug Safety Communication, Q&As and FDA news release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm