May 19, 2004: Bristol-Myers Squibb Announces U.S. Sales of Serzone to End in June
Bristol-Myers Squibb announced that Serzone will no longer be sold in the U.S. after June 14th, 2004. A company spokesperson indicated that this decision was made due to declining sales, not safety issues. Note that this action does not affect sales of generic versions of Serzone (nefazodone).
March 22, 2004: FDA Asks Antidepressant Manufacturers to Advise Observation of Patients
The U.S. Food and Drug Administration (FDA) issued a Public Health Advisory asking manufacturers of a number of anti-depressants (including Serzone, Prozac, Zoloft, Paxil, and more) to include in their product labeling a statement recommending close observation of adult and child users of the prescribed medication, for signs of increased depression and/or the emergence of suicidal impulses. Read the FDA’s Public Health Advisory here.
March 15, 2004: Public Citizen Group Sues FDA Over Failure to Ban Serzone
The consumer group Public Citizen sued the U.S. Food and Drug Administration (FDA) over its failure to act on the group’s petition seeking a ban on the antidepressant nefazodone, marketed as Serzone. The lawsuit asks the court to find the FDA’s failure to act illegal, and to require the agency to take regulatory action. Go here to see the Public Citizen press release. Click here to read the complaint filed by Public Citizen.
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