Serzone

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Serzone Withdrawal

In March 2003, Public Citizen consumer group petitioned the FDA for a Serzone withdrawal action. The consumer group noted in the petition for the Serzone withdrawal that a European Serzone withdrawal has already occurred due to the serious and deadly adverse reaction reported in Serzone patients. Since 1998, Serzone liver toxicity concerns have been associated to the drug and the consumer group has found “no justification for continuing to market this dangerous drug” based on the ongoing evidence that has led some countries to issue a Serzone withdrawal.

Serzone has also failed to show any increased efficacy than older antidepressants, though over 4.5 million prescriptions a year are written for Serzone. The failure of the FDA to issue a Serzone withdrawal despite the at least 53 cases of liver injury that includes 21 cases of liver failure resulting in 11 deaths has left the watchdog group representing 125,000 consumers nationwide to question why the U.S. is behind other countries in implementing the Serzone withdrawal. The U.S. has allowed Serzone to remain on the market while endangering a potentially high amount of Serzone patients, yet other countries have found there is enough evidence and adverse events reports to justify a Serzone withdrawal.

Defective Drugs Breaking News

"Bristol-Meyers Discontinues Serzone"

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or sell Serzone, an antidepressant that has been linked to potentially deadly liver complications and has already been withdrawn in major markets including Europe and Can...

» Read More

"FDA Sued Over Failure to Act on Petition for a Serzone Recall"

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...

» Read More

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