Submit your Defective Drugs claim details for a free, no obligation case review.
Get Started:
drug_recall serzoneSerzone has been a controversial antidepressant drug in recent years, leading to a proposed class action Serzone settlement. Manufactured by Bristol-Myers Squibb, Serzone was approved by the U.S. Food and Drug Administration in December 1994. Alleged toxicity of Serzone has brought massive litigation against the company, and the Court is holding a hearing in June 2005 to decide whether a Serzone settlement will be approved.
The FDA forced Bristol-Myers Squibb to add a “black box” warning to its labeling, the most serious FDA issued drug warning short of a recall, in January 2002. According to people seeking a Serzone settlement, problems persisted despite the liver warnings and the drug, according to Public Citizen’s director Dr. Sidney Wolfe, was still sold in the U.S. exclusively because “from a financial perspective, the only reason is to make money for Bristol-Myers Squibb.”
While the company defended Serzone as “an important therapeutic option,” they even said it was a medication for patients who have not first responded to other medications. Public Citizen consumer group sued the FDA on March 15, 2004, over its failure to act on a petition the group filed over a year beforehand seeking a ban of Serzone. The group’s push for a Serzone ban was in response to the number of deaths and cases of liver failure that had been reported, which has since been a contributor to seeking a Serzone settlement on behalf of patients and family members of deceased patients.
In Public Citizen’s original FDA petition, the group cited 21 cases of liver failure and 11 deaths between 1994 and the spring of 2002. After submitting a supplemental petition to the FDA in October 2003, the petition cited an additional 33 reports of liver failure, including nine deaths, occurring between April 1, 2002 and May 12, 2003.
Serzone was taken off the market in Europe, Australia, New Zealand and Canada, and Bristol Myers said the reason for the Canadian recall was “adverse events including liver failure,” yet sales of the drug in the U.S. continued. In May 2004, Bristol Myers finally announced that as of June 14, 2004, Serzone would be withdrawn from the U.S. market, but claimed the drug withdrawal was because of “commercial reasons.”
At the time of Serzone’s removal from the market, Public Citizen issued a statement that the withdrawal was insufficient and a complete ban was needed. Serzone is still available in channels of commerce, including wholesalers and retail pharmacies and generic versions are available.
Hundreds of patients alleging Serzone adversely affected them immediately sued Bristol Myers, though later the lawsuits were condensed to a class action and are currently pending a proposed Serzone settlement. Proposed Serzone settlements emerged because of reports of deadly liver side effects and because of Bristol Myers Squibb’s failure to acknowledge sales and manufacturing discontinuations of the drug were in response to adverse events.
Qualified individuals and surviving family members will find out if they will receive Serzone settlements for the side effects suffered that they claim are the result of taking the drug.
Drug manufacturer Bristol-Meyers announced Wednesday that it will no longer make or sell Serzone, an antidepressant that has been linked to potentially deadly liver complications and has already been withdrawn in major markets including Europe and Can...
Public Citizen has sued the FDA, calling the agency "grossly negligent" for failing to issue a Serzone ban despite having already been taken off the market in Canada and Europe, with sales to end in Australia and New Zealand in May. The consumer watchd...