Monday, June 27, 2011

Reported Side Effects of Prescription Drugs

Have you ever tried to read and understand the entire list of reported side effects (called Adverse Drug Events, or ADEs, by the industry) that comes with your prescription drugs? Or been able to follow the rapid-fire verbal description of possible side effects in a television commercial for a prescription drug?

If you can’t, you’re not alone. An article in the Archives of Internal Medicine reveals that the top 200 prescribed drugs list an average of over 100 ADEs each. Some drugs even have two opposite symptoms, such as diarrhea and constipation, or drowsiness and insomnia, among their possible side effects. That’s because drug companies would rather list all ADEs ever reported by any patient who ever took the drug, than risk a lawsuit later if they are accused of failing to warn the consumer adequately.

In fact, for many ADEs there is insufficient data to support a causal relationship between the drug and the reported ADE. Most of the symptoms attributed to ADEs occur in the general population from time to time anyway. Most of us have had diarrhea, for example, or felt drowsy and “lethargic” at one time or another, even when we were not taking any medications.

It would be nice if drug companies could find a way to separate out the important or frequent side effects from the unimportant or infrequent, without putting themselves at risk for failing to warn consumers adequately. But in our litigious society, this may be hard to do.

Reference: Duke, Jon, et al. A Quantitative Analysis of Adverse Events and “Overwarning” in Drug Labeling. Arch. Int. Med. 171:944-946, 2011.

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