How Safe Are They?

Ii's not often the FDA airs its dirty laundry in public, but when it does, boy, watch out! Appearing before a Senate committee last week, Dr. David Graham, an FDA safety officer, testified that there are five drugs on the market that he had serious concerns about and then, in a rare display of FDA indiscretion, he actually named them. Other agency officials quickly took issue with the assessment, and the next day the FDA released a statement declaring that all five drugs are quite "safe and effective." But anyone on one of the medications is bound to be confused. What are the facts? Let's take the drugs one at a time.

ACCUTANE This drug works wonders for severe acne when all else fails. Doctors have long known, however, that Accutane (generic name: isotretinoin) can cause birth defects in pregnant women. Indeed, the drug comes with a black-box warning, the strongest available to the FDA, to that effect. But each year several women still become pregnant while on it.

BEXTRA Like the other COX-2 pain relievers, Pfizer's Bextra doesn't work any better than Advil but may be easier on the stomach. Reports suggest Bextra may sometimes cause blood-pressure problems; Pfizer is working with the FDA to get to the bottom of the matter.

CRESTOR Graham cited reports that some patients on Crestor, one of the newest anticholesterol statins, have suffered kidney failure. The drug's manufacturer, AstraZeneca, says the prescription drug is safe as long as it is used properly.

MERIDIA One of the few remaining drug treatments for obesity after fen-phen and Redux were pulled from the market, Meridia has been associated with blood-pressure problems in some people. But, says the drug's maker, you have to balance that potential problem against the severe health risks of obesity.

SEREVENT Like many antiasthma drugs, Serevent can, paradoxically, trigger life-threatening spasms in the lungs. The risk from Serevent appears to be greater for African Americans, and last year the company agreed to include a black-box warning on this possible side effect.

If you're taking one of those drugs, you should definitely talk to your doctor. You might also read the package inserts that come with your prescription; you may find something your physician has overlooked. And it never hurts to ask about alternative treatments. If there are good ones, it might be prudent to switch until everything gets sorted out.