Citing poor sells, Bristol-Myers Squibb said Wednesday that it will stop selling its controversial antidepressant drug Serzone in the United States as of June 14. But critics blame the drug’s risk of liver failure, which has brought many lawsuits against the company, for the withdrawal.
Public Citizen, a consumer advocate group, said the company’s action is not enough for two reasons: First because Bristol-Myers Squibb is not recalling Serzone.
“The company will be able to fill (or refill) prescriptions for many more months after June 14, because the drug will still be available in channels of commerce including wholesalers and retail pharmacies,” the group said in a prepared statement issued on Wednesday.
Second, because a number generic versions of Serzone are now available.
“The U.S. Food and Drug Administration must force those companies to remove their drugs from the market,” the group said. “Otherwise, the cases of liver failure, liver transplant and death will continue with the generic versions of” Serzone.
Public Citizen sued the FDA on March 15 over its failure to act on a petition it filed a year ago seeking a ban of Serzone because it had been linked to a mounting number of deaths and serious injuries from liver failure. That petition cited 21 cases of liver failure and 11 deaths between 1994, when Serzone was first marketed, and spring 2002, the group said.
The group submitted a supplemental petition to the FDA in October 2003, highlighting 33 additional reports of liver failure, including nine deaths, from April 1, 2002, through May 12, 2003, for a total of 55 patients with liver failure, including 20 deaths.
(via Public Citizen)
2 responses so far ↓
Cosmo Topper // Jul 16, 2004 at 5:00 pm
In the Serzone controversy, has there been any consideration of the millions of depresives who depend on its benefits? Where is the counter balance about patients who cannot get relief from depression from any other medications? In my experience I know depresives who rather die of liver falure than live without Nefazodone. Has there been a study of these links between liver disease and dosage?
Lawrence Kahn // Dec 3, 2004 at 5:22 pm
This stuff ruined my life from 1996 through 2003. I stopped taking it cold about 9 months ago when I found out - accidentally - that I was taking a very high dose. Only now are things getting back to normal. I was arrested in 1997 because I was so affected by Serzone that I thought it was MY job to punish a local electronics superstore that was advertising items they didn’t have. Now I have a damned ARREST record, and probably won’t be able to get a security clearance again. Thank you, Serzone. Without my knowing it, Serzone affected my balance to the extent that I fell and needed spinal fusion surgery in 2001 to “repair” a serious and unbelievably painful injury I sustained in November 2000. I thought I was going blind because Serzone screws up vision and causes visual hallucinations. I saw four high-powered ophthalmologists who had no idea what caused the little transitory images. Serzone CAUSES suicidal depression. I spent a year, inert, trying to think of a way to kill myself without making a mess for my wife to find. I wasted an expensive vacation to Scandinavia my wife treated me to by looking for methods of just disappearing at sea. I had no interest in doing my back exercises after spinal surgery, so I never will recover completely, plus there is much lingering pain and a great loss of flexibility. I wasn’t even depressed before I took Serzone - it was prescribed to help me deal with the extreme upset caused by sensitivity to noise at home and others BSing about sports at work. Didn’t help with that, either. As a diabetic, my liver functions are questionable anyway. I have no idea how much extra liver damage was caused. I wish I’d never heard of this junk. If you are truly depressed - and I had a mother who was, so I am not insensitive or unaware - please try SOMETHING ELSE. My doctors kept increasing the dose of Serzone to help me deal with the depression caused by taking Serzone. Seemed to make sense at the time.
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