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Be Well

New Medication Safety

by John Swartzberg, M.D.  

If you have a choice between a prescription drug that has been used with good results for years and a new one that’s boldly advertised as the latest breakthrough, do you assume that newer is better? It’s tempting to think so, especially when the new drug is pricey and the old one is, most likely, an inexpensive generic. While newer may be better with computers and cell phones, it isn’t necessarily true of medicine.

Yes, many new drugs offer improved treatment. But sometimes they’re simply additional options. They gain traction as a result of company-sponsored research, splashy marketing and wishful thinking, in equal parts.

And most of the time, until the drugs are in wide use for a few years and the dust settles, no one really knows how effective—and safe—they really are.

Does that surprise you? Many people mistakenly believe that only very effective drugs with known (and not too serious) side effects are approved by the Food and Drug Administration (FDA), and they’re unaware of the uncertainties surrounding relatively new drugs, according to a recent study in the Archives of Internal Medicine, which examined such beliefs about drugs.

The study also tested how a brief explanation about the uncertainties surrounding the safety and efficacy of new drugs can influence consumer choices. For instance, simply telling people that “it takes time to establish the safety of new drugs” or “ask for a drug with a longer track record” increased the likelihood that they would choose an older, established drug over a newly approved one. (Even so, half still chose the newer drug.)

The FDA should ensure that ads and patient educational materials be clear about the uncertainties inherent in all new drugs, the study’s authors concluded. Still, your best bet is to talk to your doctor about drug choices. As a general rule, I discourage patients from taking drugs that have been marketed for less than three years, unless there are no other options. That allows time for additional evaluation regarding benefits and harms.

If you had followed this three-year rule, you could have avoided, for instance, the prescription pain reliever Vioxx, which was supposed to be safer than aspirin, ibuprofen and similar drugs. After $2 billion in sales in its first few years, the drug was withdrawn from the market in 2003 when it was found that it increased heart attacks and strokes.

Nowhere is being tried and true more important than with medication. Older drugs are almost always cheaper, too.