In December 7, 2001, the
U.S. Food and Drug Administration made Bristol-Meyers
change Serzone's label to show a "black box warning."
This kind of label means that this drug has the most
serious side effects. For example, Serzone has
been linked to fatal hepatic or liver failure.
Weeks later, Bristol-Myers Squibb
told health care
providers that Serzone had been linked to patients suffering
from
life-threatening liver failure.
In January 2003, the
manufacturer of Serzone pulled this medication
from the European shelves because of its connection to
twenty-five cases of liver failure and eighteen deaths.
It
has also been reported that Serzone has been prescribed
to children which lead to liver failure, jaundice, and
hepatitis. Many of these children had to undergo
liver transplants to survive.
