Americans spend billions of dollars each year on medications to treat
depression and to relieve anxiety. Depression is a real illness, and
patients who suffer from clinical depression desperately seek help for
their condition. Doctors and patients trust pharmaceutical companies to
provide safe and effective treatments. In the case of Serzone, that
trust was broken. Depressed patients who have taken Serzone have
suffered severe liver damage, resulting in liver failure, the need for a
liver transplant, and death. The FDA issued an important drug warning
in December 2001.
The FDA warning including a Black Box warning, a special designation
reserved for the FDA's most serious medication warnings. The FDA warning
stated, "Patients should be informed that Serzone therapy has been
associated with liver abnormalities ranging from asymptomatic reversible
serum transaminase increases to cases of liver failure resulting in
transplant and/or death. At present, there is no way to predict who is
likely to develop liver failure".
Other health agencies are also
concerned about the safety of Serzone.
Research from the World Health Organization found a significant
correlation between the use of Serzone and liver failure. Less
serious side effects include sleepiness, dry mouth, nausea, dizziness,
constipation, weakness, lightheadedness, problems with vision, and
The problems with Serzone are summarized in a
letter sent from the maker of Serzone to health care professionals
in Canada. In this letter, Bristol-Meyers Squib states, "Since its introduction in 1994, nefazodone has been temporally
associated with hepatic adverse events such as jaundice, hepatitis, and hepatocellular necrosis in patients receiving therapeutic doses. As of
December 2002, there were 51 Canadian reports of hepatotoxicity, ranging
from no symptoms to transplantation, suspected to be associated with
nefazodone use. One of the two transplant recipients subsequently died.
Cases of liver injury have occurred as early as a few weeks after
initiation of therapy or after continuous use for up to three years. To
date, no risk factor to predict patients who will develop irreversible
liver failure with nefazodone has been identified. Also no clinical
strategy, such as routine liver function tests, could be identified to
reduce the risk of liver failure".
information for Serzone warns patients taking the medication to
watch for signs of liver damage, including yellowing of the skin or
whites of eyes (jaundice), unusually dark urine, loss of appetite that
lasts several days or longer, nausea, and abdominal (lower stomach)
pain. Notify your doctor if you are taking Serzone and have experienced
any of these symptoms.