Teen Death Stirs Fresh Debate About
Bristol-Myers's Serzone, Despite
Removal Elsewhere, Is Still Available in U.S.
By BARBARA MARTINEZ Staff
Reporter of THE WALL STREET JOURNAL
April 20, 2004; Page D5
The death of a teenager last week
from liver failure is raising questions anew about an antidepressant
that continues to be available in the U.S. despite having been
removed from the market in other countries.
Co.'s Serzone was taken off the market in Europe in early
2003 and in Canada in the fall of last year. Last month, the
advocacy group Public Citizen sued the Food and Drug Administration,
seeking to halt sales of the drug, one year after the group filed a
petition to get Serzone banned in the U.S.
A spokeswoman for the FDA said the
agency is still reviewing Public Citizen's petition to remove the
drug from the market and continues to monitor reports of "adverse
events." She said the agency's previous review of the drug resulted
in a stronger warning on side effects but that the reports of liver
damage were "very rare" and "with appropriate labeling, the drug
still had a role in the U.S. in people that couldn't use" other
In 2001, the FDA required
Bristol-Myers to send a letter to doctors warning of potential liver
damage in users of the drug. A so-called black-box warning also was
added to the drug's label, highlighting the potentially dangerous
side effect on the liver. As lawsuits have piled up over the drug,
sales have declined. According to NDCHealth, a health-care
information-services company, sales of Serzone fell last year to
$170 million, down from $378 million in 2001.
About 1.5 million prescriptions were
written for the drug last year. Sidney Wolfe, director of Public
Citizen's Health Research Group, said that the still-large number of
prescriptions shows that doctors are slow to learn about black-box
warnings, particularly if they have been prescribing a certain drug
for a long time. The fact that the drug is still being prescribed,
when there are at least a dozen other options, "shows that the
company was successful in promoting the drug" since it was
introduced in 1994, Dr. Wolfe said.
Serzone works somewhat differently
from more popular antidepressants such as Prozac and Zoloft by
affecting two neurotransmitters instead of one.
In its petition to the FDA, Public
Citizen cites the FDA's own figures for Serzone's effects on
patients. According to the group, the FDA's adverse-event database
recorded 20 deaths in the U.S. from liver failure in people using
Serzone, including a six-year-old child. Dr. Wolfe said that some of
the deaths were in patients who began using Serzone after the
black-box warning went on the labels.
A spokesman for Bristol-Myers said,
"Bristol-Myers, the FDA and U.S. prescribing physicians all believe
the drug has a role in the treatment of depression." The spokesman
said the company "discontinued sales in the vast majority of
European countries due to business reasons."
Earlier this month, Cassie Jo
Geisenhof died from liver failure as a result of taking Serzone,
said her lawyer, Andy Birchfield of Beasley, Allen, Crow, Methvin
Portis and Miles, in Montgomery , Ala. Ms. Geisenhof, who lived in
Minnesota , had taken Serzone for four months to treat mild
depression when she was 15. Soon after, she had liver failure and
underwent liver-transplant surgery, Mr. Birchfield said. But her
body rejected the new liver, and she was in and out of hospitals
until her death, at age 19.
Bristol-Myers lost patent protection
for the drug last fall. According to NDCHealth, sales of the generic
version of the drug, nefazodone, totaled $23 million last year.
While liver toxicity is a separate
issue, many heavily prescribed antidepressants are now under
scrutiny for possible connections to suicidal thoughts, especially
in teenagers. Last month, the FDA asked drug makers to put warnings
on 10 antidepressants urging doctors and patients to closely monitor
teenage patients for suicidal behavior when treatment starts.