Another day, another warning from the Food and Drug Administration.
Such is the new paradigm for drug developers. The FDA is going to make darn sure consumers know everything about every possible side effect that a drug could cause.
The latest victim was the TNF inhibitors -- Amgen's (NASDAQ:AMGN) and Wyeth's (NYSE:WYE) Enbrel, Abbott Labs' (NYSE:ABT) Humira, UCB's Cimzia, and Johnson & Johnson's (NYSE:JNJ) Remicade, which is sold outside the U.S. by Schering-Plough (NYSE:SGP). These drugs inhibit the immune system to treat rheumatoid arthritis, Crohn's disease, and other autoimmune conditions. The FDA warning results from numerous reports of fungal infections in patients taking the TNF inhibitors, including 12 deaths.
I am shocked, shocked to find this out! You mean drugs that inhibit the immune system might also affect the immune system's ability to fight a fungal infection?
Of course, I'm being facetious. The drugs already warn about this possibility right on the label (first page, even), but apparently the FDA wants the warning to stand out more, so that doctors, hopefully, will see it and recognize the signs of infection earlier.
The same group got bad press a few months ago when the FDA started looking at the possibility that the drugs are linked to cancer. In my opinion, neither any warning for that or this new one will likely decrease the multibillion-dollar sales these blockbusters have because the drugs are so effective. Heck, even aspirin has side effects!
Ironically, the increase in warnings by the FDA could backfire. If doctors become swamped with increased numbers of warnings, from Amylin Pharmaceuticals' Byetta's potential link to pancreatitis to a response to reports of more cases of a rare brain disorder in patients taking Elan (NYSE:ELN) and Biogen Idec's (NASDAQ:BIIB) Tysabri to these new ones for TNF blockers, the doctors (and patients) may begin to tune them out.
While that's not going to benefit patients -- and drugmakers certainly don't want to do harm -- it could be beneficial to the myriad of drugmakers that are getting stuck with warning after warning for rare and known side effects.
Welcome to the new FDA -- more drug warnings and fewer drug approvals.
Warning: more Foolishness ahead:
