Warnings on Cold and Diet Drugs Praised

      New safety alerts about popular diet drugs and cold remedies were widely applauded around the country Friday by health experts long concerned about the dangers of mass-marketed medicine.

      The U.S. Food and Drug Administration is considering an advisory panel''s recommendation to restrict sale of over-the-counter products containing the active ingredient phenylpropanolamine, known as PPA, which is feared to heighten risk of stroke in some users.

      ``People think over-the-counter medications are always safe, when in fact they are not,'' said Dr. Ravinder Singh, a Beverly Hills neurologist who specializes in treating stroke cases. ``This underscores the point that there may be effects we don''t always understand, and not all drugs are safe in everybody.''

      On Thursday, the FDA advisory panel refused to accept industry arguments that the ingredient deserves its present classification of ``generally recognized as safe'' - necessary for a medication to be sold without a doctor''s prescription.

      The move follows a decade of medical debate about PPA''s possible role in deadly hemorrhagic strokes, particularly in younger women trying to lose weight and first-time users. Exactly how PPA can lead to a stroke is unclear, but it could involve sudden changes in blood pressure.

      Some of the most heavily advertised products lining drugstore shelves may have to be reformulated or converted to prescription-only products if the FDA eventually goes along with the panel''s advice. A decision is expected in about three or four months.

      Close to 6 billion doses of PPA-containing products are sold in the United States annually. Products include the appetite suppressants AcuTrim and Dexatrim, as well as a host of decongestants and combination cold remedies, including such brand names as Alka-Seltzer Plus, Contac and Dimetapp.

      R. William Soller, senior vice president of the Consumer Healthcare Products Association, a trade group representing manufacturers of nonprescription drugs, said the FDA panel misread the evidence. He insisted that the products are safe when used according to instructions.

      Studies to the contrary point to ``very small risk,'' he said, and also do not account for underlying stroke risk factors, including alcohol and cocaine use.

      Although all the over-the-counter dietary aids contain PPA, there are several prescription-only alternatives. Most experts say that in general, long-term changes in exercise habits and diet are the only real solution to losing weight.

      As for drugstore cold remedies, most decongestants already use a different active ingredient, such as pseudoephedrine or phenylephrine. There are also several cold products on the market containing zinc as the active ingredient.

      Concern about the potential dangers of PPA-containing products are hardly new.

      Actual reports of stroke in people taking PPA number only 44 since 1969, but an FDA statistical review suggested the ingredient may be causing as many as 500 strokes a year in the United States.

      In 1996, the FDA began pushing manufacturers to modify product labels to combat overdoses and dangerous drug interactions.

      Users are warned not to take PPA with other cold remedies that can have effects similar to those of PPA. The drug also interacts with a type of antidepressant, known as monoamine oxidase inhibitors, or MAOIs, to cause life-threatening cardiovascular problems.

      Pharmacist Candy Tsouranis, an assistant clinical professor at the University of California at San Francisco School of Pharmacy, said PPA is ``certainly risky,'' particularly when used for long periods of time to lose weight, and should not be licensed for over-the-counter sale.

      ``These drugs should be pulled. When they are sold over the counter, you can''t control how much consumers take,'' she said. ``Even if you put something on the labels, people are under the impression that if a little is good, then a lot is better.''

      Beyond the catastrophic risks of stroke, she added, a far more common problem with PPA as an appetite suppressant is that the resulting weight loss tends to be small - just three to eight pounds for most people. Moreover, appetite returns to previous levels once the drug is no longer taken.

     

c.2000 San Francisco Chronicle