Serzone™ (nefazodone HCl) is used to treat depression.
It is administered in tablet form, in dosages of 50 mg, 100 mg,
150 mg, 200 mg and 250 mg, and is manufactured by Bristol-Myers
Squibb Co. Worldwide sales of Serzone were $409 million in 2001.
On December 7, 2001, the Food and
Drug Administration informed
Bristol-Meyers Squib Co. that it must include a "black-box" warning
on the labels of Serzone. This warning came after it was learned
that Serzone was responsible for life-threatening liver failures
that led to death or the necessity of a liver transplant. A black-box
designation is reserved for only the most serious side effects
On January 9, 2002, Bristol-Myers Squib issued a manufacturer's
warning advising health care providers that "cases of life-threatening
liver failure have been reported in patients treated with Serzone" and
that the rate of liver failure associated with its use is "about
3-4 times the estimated background rate of liver failure." FDA
psychopharmacology team leader Thomas Laughren, commented on
the liver failure reports with Serzone patients, "We believe
that it's drug-related and that this drug is different from the
others in the class."
A new warning has being added to Serzone prescribing information,
recommending that "patients should be advised to be alert for
signs and symptoms of liver dysfunction, such as jaundice, dark
colored urine, loss of appetite, nausea, gastrointestinal complaints
and malaise, and to report them to their doctors immediately
should they occur." Cases involving liver failures were
reported after 2 weeks to 6 months of Serzone therapy.
It is strongly advised that anyone who has taken Serzone in
the past, or is currently taking Serzone, should contact a health
care professional for further information. If you or someone
you know has experienced a serious or fatal injury from the use
of Serzone, you may have a valid legal claim for this loss.