FDA is gunning for Neurontin

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.

Pfizer’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, Pfizer’s Warner Lambert division recently paid $430 million in fines for illegally marketing Neurontin “for illnesses ranging from migraines to hiccups.”

It’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 don’t need their drugs, the industry has put itself in danger of having its products removed from the shelves. As I’ve written recently, that’s what appears to have happened with Vioxx and Bextra, and there’s a real risk of the same thing happening with asthma drugs.

It’s a real shame for the seriously ill patients who depend on these drugs. Rather than seeing drugs pulled from the market, I’d like to see physicians step up and take a more skeptical view of what they hear from drug reps.

April 21, 2005

One thought on “FDA is gunning for Neurontin”

  1. I have A LOT to say on how the high dosages of Neurontin as a pain killer- pre and post major spine surgery -resulted in a totally debilitating depression, a suidide attempt and exhibition of bipolar symptoms, after 60 years of exhibiting little more than occassioanl depressive episodes that never prevented me from altering my high level professional career, completing a PhD at age 50 while working full time while attending to familiy and social obligations. After my Neurontin disasterous side effects my life was ruined. I started Neurontin April 04 and was kept on it till April 2005,when my symptoms exploded. A few months later at age 60 I was forced to retire, causing me to lose my home and a husband unable to cope with the vegetable who was always “super woman”. Please, I beg you get the word out. I’m the poster child for a highly successful woman blessed with a satisfying life who has been reuced to the status of a disabled senior citizen due to the temporary (but medically recorded psychotic diagnosis of suicide prone and bipolar persoality). I now attend Zen Center, volunteer with many charities read and study extensively, but continue to be urged to say on Lamictal, Effexor and Xanax “just in case” – a continued “abuse” caused by my iatrogenically induced disease, by a discounting of 60 highly successful years, and a “cautionary care” provided by my quite excellent current physicians who view my current full and productive life as perhaps only temporary.

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