Wednesday, July 1, 2009

Proposed FDA Action To Cut Doses of Tylenol Shows Need for Disclosure in Ads of Active Ingredients

Advertising for over-the-counter medicines should disclose the active ingredients in them.

That should be the take-home message today in response to the news that an FDA advisory panel has recommended that Tylenol be sold in doses of no more than 325 milligrams, and that Percocet and Vicodin be banned altogether.

The sad fact is that the need for disclosure has been apparent for years. Ten years ago, The Women's Consumer Foundation conducted a face-to-face survey of 181 inner-city women that found a dangerous lack of understanding of the most basic information about over-the-counter (OTC) drugs. Many of the women--almost half--were taking medicines like Tylenol without knowing what was in them, and many were taking more than the recommended doses without realizing the danger.

Fewer than half the women knew that acetaminophen is the active ingredient in Tylenol (they were given four possible answers from which to choose) despite the fact that Tylenol was the drug that the women said they bought most often.

And, most dangerous of all, 44 percent of the women said they knew people who very often, or somewhat often, took more than the recommended dosages; 25 percent admitted to doing so themselves.

At the time we first published these findings on our not-for-profit website, SIS (now defunct, as is the Women's Consumer Foundation), the drug manufacturers claimed that our findings were wrong, that people do read and understand labels and don't take more than the recommended doses.

This latest recommendation by the FDA panel puts the lie to those assertions because it was based on statistics showing that 400 people die every year, and 42,000 are hospitalized in the U.S. because they overdosed themselves. Percocet and Vicodin contain a narcotic and acetaminophen, which is a leading cause of liver damage.

The panel members agreed that consumers need to be better educated about OTC medicines, and I concur.

The simplest way to do that is via the ads for these drugs. The FDA should require that all advertising for OTC drugs disclose the generic names of their active ingredients.

This remedy was actually proposed by a Federal Trade Commission administrative law judge more than 20 years ago. Sadly, the commission decided not to follow the recommendation.

So in all the years since, consumers have been bombarded with billions of dollars of OTC drug ads that mis-educate them, that lead them to believe that Tylenol contains some unique ingredient. Ditto for Nyquil, TheraFlu, Alka-Seltzer, etc. In reality, these expensive brand name products contain inexpensive ingredients that can be bought generically for far less--often 50 percent less.

So hundreds of people are dying, thousands are ending up in hospitals and millions are wasting their money because of advertising that misinforms and fails to provide the most necessary, basic information: the active ingredients in the medications.

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