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Bristol-Meyers Squib acknowledges that it has known about the risk of
Serzone since its introduction in 1994. Nevertheless, the company
continued to promote the medication as an acceptable treatment for
depression while downplaying the risks of liver damage resulting in
liver failure.
Company literature states, "Rarely, patients treated with Serzone
(nefazodone HCl) can develop serious liver problems."
"Rarely" is a subjective term. According to a report in the Wall Street
Journal, about one person in 250,000 to 300,000 taking Serzone will
suffer liver failure. In a
letter to health care providers, Bristol Meyers acknowledges that
the rate of liver failure among patients taking Serzone is "about 3-4
times the estimated background rate of liver failure"'. Further,
the company admits that "This rate is an underestimate because of under
reporting and the true risk could be "considerably greater".
An investigation by an independent consumer safety group reflects the
extent of the problem. In a
letter to the FDA, the consumer watchdog group Public Citizen,
wrote, "Our search revealed 11 deaths; four of the patients that died
had liver transplants. In addition, there were 42 non-fatal hepatic
adverse events including two cases of hepatic necrosis, 11 cases of
hepatic failure, and three liver transplants. Twenty-nine of the non-fatal
reactions (71%) required hospitalization. Patients were quite young
overall: the median age was 42 years old with four patients in their teens
(14, 16, 16, and 19). Because of the well-known low rate of spontaneous
adverse event reporting, all the numbers in the AERS database can
probably be multiplied by 10, at least, as an estimate of the true
situation."
Despite the known risk, and the Serzone litigation, Bristol-Meyers continues to produce and
distribute Serzone.
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