Pfizer has withdrawn the COX-2 inhibitor Bextra off the market under FDA pressure. They are also putting a “black box” warning on their older drug Celebrex, which is now the only COX-2 inhibitor left on the U.S. market, since Merck withdrew Vioxx last year under similar pressure.
The FDA is also requiring new warnings on nonspecific COX-1/2 inhibitors, more commonly known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) — the most common ones being Ibuprofen (Motrin, Advil, etc.) and Naproxen (Aleve, etc.). The public FDA statement is here.
I have my doubts that this is the right decision — that is, I’m sure all these drugs have risks, like all drugs do, but I’m not sure the risks are so severe as to justify taking them off the market completely, instead of just warning doctors to be careful to whom they prescribe them, and patients to watch for side effects. Of course, I can’t actually find out whether my doubts are valid, because the research on which these decisions are based appears not to have been published so far. (If anyone knows where I can find it, let me know!)
The fact that the information is not yet public is part of the problem. It appears that the FDA would rather have you suffer indescribable pain and be bedridden with arthritis (for example), than have you run a slight risk of a heart attack. (A risk which you might be able to mitigate with exercise, that you can’t get without athritis medicine.) Or to put it a different way, they’d rather you die of a bleeding ulcer from taking too much aspirin or ibuprofen, than die of a heart attack from taking Bextra or Vioxx. I don’t doubt that many patients, evaluating the risk-benefit trade-off with their doctors, would make the same decision. But I also don’t doubt that many would make the opposite decision, and the FDA seems to fear that — even though it’s the patients, not the FDA, who have to live with the consequences of whatever decision is made. I don’t know what the folks at the FDA actually believe, but they seem to act as if they believe that doctors and patients are too stupid to make their own decisions — and they certainly act like they believe they are able to make decisions for everybody. Not only that, but the right decision is the same one for every single patient in the country!
It is highly ironic that in this country, you have the right to make a “living will” guaranteeing yourself certain (100% chance of) death by dehydration if your health deteriorates, but if you have severe arthritis, you don’t have the right to take a 1.5% chance of death by heart attack by taking a medicine that makes you comfortable enough to get out of bed and live a somewhat normal life.