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FDA ANNOUNCES WITHDRAWAL OF FENFLURAMINE AND DEXFENFLURAMINE:

The Food and Drug Administration, acting on new evidence about significant side-effects associated with fenfluramine and dexfenfluramine, has asked the manufacturers to voluntarily withdraw both treatments for obesity from the market. Dexfenfluramine is manufactured for Interneuron Pharmaceuticals and marketed under the name of Redux by Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. of Madison, N.J., which also manufactures and markets fenfluramine under the brand name Pondimin. Both companies have agreed to voluntarily withdraw their drugs. The FDA is not requesting the withdrawal of phentermine, the third widely used medication for obesity.

The action is based on new findings from doctors who have evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results.

"These findings call for prompt action," said Michael A. Friedman, M.D., the Lead Deputy Commissioner of the FDA. "The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine, present an unacceptable risk at this time to patients who take them."

FDA recommends that patients using either of these products stop taking them. Users of these two products should contact their doctors to discuss their treatment.

These new findings suggest fenfluramine and dexfenfluramine are the likely cause of heart valve problems of the type that prompted FDA's two earlier warnings concerning "fen-phen," a combination of fenfluramine and phentermine. "Fen-phen" has been widely used off-label in recent years for the long-term management of obesity.

In July, researchers at the Mayo Clinic and Mayo Foundation reported 24 cases of rare valvular disease in women who took the "fen-phen" combination therapy. FDA alerted medical doctors that it had received nine additional reports of the same type, and requested all health care professionals to report any such cases to the agency's MedWatch program (1-800-FDA-1088/fax 1-800-FDA -0178) or to the respective pharmaceutical manufacturers.

Subsequently, FDA received 66 additional reports of heart valve disease associated mainly with "fen-phen." There were also reports of cases seen in patients taking only fenfluramine or dexfenfluramine. FDA requested that the manufacturers of fenfluramine and dexfenfluramine stress the potential risk to the heart in the drugs' labeling and patient package inserts. FDA continues to receive reports of cardiac valvular disease in persons who have taken these drugs.

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So called HERBAL FEN-PHEN is really totally different than the medication known as fen-phen (taken off the market, read above). It's name is just a marketing ploy to get consumers to think they're getting a natural substitute that is safer than the synthetic version.

The herbal "fen-phen" seen in stores is based on ephedra and other stimulants, like kola nut, a caffeine source. These work by curbing your appetite and increasing your metabolism. But all stimulants can cause dependence as well as trigger nervousness, anxiety and insomnia. Ephedra, also known as ma huang, though useful as a treatment for asthma, is not helpful for long-term weight loss. Plus it's very likely that once you stop using a substance like this, you'll gain the weight you lost right back.

Women who have regular mammograms understand what a breast mass is, but few are prepared for a diagnosis and decision about microcalcifications. A seven page article about this topic includes information about types of calcifications, recommendations for follow-up, stereotactic core biopsy and diagnostic options. For a copy, write to the Women's Cancer Resource Center, Microcalcification Awareness/Action Committee, 3023 Shattuck Avenue, Berkeley, California 94705. Send a self-addressed stamped business envelope from the US: from Canada, use a US 40 cents stamp or enclose two American quarters to cover the cost of mailing. Donations are welcome to cover printing. (The Network News, May/June 1996)


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In the 12 years that Seldane has been on the market, the antihistamine has been associated with a number of cases of potentially fatal heart-rhythm disturbances. About 40 cases, including 8 deaths, were reported when Seldane was taken with the antifungal drugs ketoconazole or itraconazole or the antibiotic erythromycin. Seldane's manufacturer, Hoechst Marion Roussel, has been required to label the product with a warning of such side effects.
   Hoechst has developed a new drug, Allegra, in which Seldane's activity was preserved but it's side effects eliminated. Like Seldane, Claritin (Ioratadine), and Hismanal (astemizole), Allegra is considered to be a second generation antihistamine. That is, it relieves the symptoms of hayfever and other allergies without causing drowsiness. None of the three drugs have been associated with any hazardous side effects.
   Recently, the FDA approved a generic terfenadine, which, as a carbon copy of Seldane, has the same potential side effects. Shortly thereafter, the FDA proposed a ban of both Seldane and its generic counterpart.
   If you need a nonsedating antihistamine, Claritin, Hismanal, or Allegra are wiser choices than Seldane or generic terfenadine.

ALPHA-HYDROXY WARNING

At least one study has indicated that the continued use of products containing a 25% concentration of alpha-hydroxy acids (AHA's) can increase collagen production to produce smoother-looking skin. However, there is increasing evidence that AHA products can also cause skin damage.

The problem stems from the classification of these products. High-concentration AHA products are used primarily by physicians for chemical face peels--- procedures that remove the outer layer of skin to reduce wrinkles, blemishes and acne scars---and are regulated as drugs by the Food and Drug Administration. They have been demonstrated to be safe and effective when used as prescribed. In contrast, preparations containing up to 30% concentrations of AHAs may be used by cosmetologists, and products containing up to 10% concentrations are available over the counter. Considered cosmetics, these are not regulated by the FDA.

All AHA products cause exfoliation, or shedding of the surface skin. The extent of the effect depends on the type and concentration of the AHA, the acidity or pH of the product, and the ingredients other than the AHAs.

A recent study, sponsored by the Cosmetic, Toiletry, and Fragrance Association, indicated that the AHAs also increase the skins sensitivity to ultraviolet radiation--in effect, making it more susceptible to sun damage. Nontheless, the association's Cosmetic Ingrediant Review Panel has concluded that the products at cosmetic counters or employed in salon treatments are safe.

The FDA is currently reviewing that report as well as other information on the effects of AHAs. Although as cosmetics, AHA products do not have to have FDA approval for marketing, the FDA can remove then from the shelves if they are demonstrated to be unsafe. In 1992 it took action against PeelAway--a product containing AHAs and other acids---after several people who used it sustained severe burns. Since then, the FDA has received approximately 100 reports of adverse effects associated with AHA products, ranging from minor irritation to blistering and burns.

For now, the problem with most over-the-counter products is the lack of information about them; manufacturers are not required to divulge either the AHA concentration or the pH of the products, but you may be able to get these figures by contacting the company. However, the lable must list the ingredients. If any of the following substances are on the lable, the product contains AHAs: glycolic acid, lactic acid, malic acid, citric acid, alpha-hedroxyethanoic acid, alpha-hydroxyocanoic acid, alphs-hydroxycaprylic acid, mixed fruit acid, tri-alpha hydroxy fruit acid, triple fruit acid, sugar cane extract, alpha hydroxy and botanical complex, L-alpha hydroxy acid, and glycomer in crosslinked fatty acids alpha nutrium.

If you are using a product with any of the above ingredients for the first time, test it on a small patch of skin before applying it to a large area. Stop if you feel stinging or burning. Always follow up with a generous application of sunscreen that has a skin protection factor (SPF) of at least 15.