Case Evaluation

Serzone: Serzone Ban Finally Issued

Serzone Ban Finally Issued

Serzone has been linked to dozens of liver failures, including at least 21 U.S. deaths. In 2002, the FDA required Bristol Myers Squibb add serious liver warnings to Serzone, but this measure was not considered adequate enough as reports continued to be made. Serzone was considered so dangerous that sales in Canada, Europe, and later Australia and New Zealand were discontinued. In the U.S., a Serzone ban was not issued, despite a 2003 petition to the FDA to ban the drug issued by the Public Citizen consumer group. When the FDA still did not act on the Public Citizen's petition, the consumer group sued the federal agency. After much controversy, the manufacturer has just announced that Serzone sales will end June 14, 2004, but generic sales of versions of Serzone will still remain on the market. Public Citizen is demanding the FDA remove all versions of Serzone from the market, and the group has announced it will continue its lawsuits for failing to act on the year old petition to immediately ban Serzone. The Serzone recall has been in response to fear of massive litigation according to Public Citizen.

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