FDA Official Sews More Confusion Over Painkiller Warnings

Interesting story here about whether the FDA has been consistent in its treatment of Cox-2, NSAIDs and other painkillers. The feds recently ruled that all NSAID painkillers should carry harsher warnings, even OTCs. But naproxen (Aleve) should not have a black box warning, says Curt Furberg, who’s on the FDA’s drug safety committee, because the evidence shows its safer. On the other hand, diclofenac (Voltaren) carries the same warning as Aleve, even though Furberg says it’s as dangerous as Vioxx and Bextra—which have been taken off the market. (Thanks to Internet Drug News for digging out this one.)

My 2 cents: The dosage of Voltaren cited in this story is quite a high one—75 mg twice daily. Does every patient need that much? I think not. The bottom line is that all these drugs should be on the market, and they should all carry appropriate warnings. I've argued the same point here. Patients need options, even if those options are risky.

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I respect Sydney Wolfe's position on this matter—anecdotal evidence that some patients respond well to a risky drug is not science proving that a drug should be on the market. But, what Wolfe doesn't say is that good science doesn't prove that there will be a safe drug for every patient. As long as patients start at the safe end of the scale, and only step up to the more risky treatments when options run out, then doctors should have the right to tell their patients about drugs even when they are risky. And drug companies should have the right to sell them.

The weak link in this chain, however, are the DTC brand managers. To be credible on this issue they need to market powerful, new and risky drugs in responsible and informative ways. So far, only Pfizer, in its new Celebrex campaign, has had the cojones to be upfront about risks and benefits.

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