The FDA is asking makers of anticonvulsants to re-examine their clinical trial data to see if the drugs increase suicide risk. This is the same path that led to the placement of black box warnings on all antidepressants, making doctors warier about prescribing them.
Pfizerâ€™s Neurontin is the leading drug in the class, and is also the poster child for overly aggressive pharmaceutical market expansion efforts and dubious post-marketing research. As the Boston Globe notes, Pfizerâ€™s Warner Lambert division recently paid $430 million in fines for illegally marketing Neurontin â€œfor illnesses ranging from migraines to hiccups.â€
Itâ€™s one thing to tolerate rare but serious risks in the treatment of major illnesses such as epilepsy and bipolar disorder. But the same level of risk is unacceptable for hiccups. By marketing overzealously to people with minor illnesses who donâ€™t need their drugs, the industry has put itself in danger of having its products removed from the shelves. As Iâ€™ve written recently, thatâ€™s what appears to have happened with Vioxx and Bextra, and thereâ€™s a real risk of the same thing happening with asthma drugs.
Itâ€™s a real shame for the seriously ill patients who depend on these drugs. Rather than seeing drugs pulled from the market, Iâ€™d like to see physicians step up and take a more skeptical view of what they hear from drug reps.April 21, 2005