March 15, 2004 — A consumer advocacy group is taking the FDA to court over an antidepressant drug that the group claims should be banned due to the risk of death and serious injuries from liver failure.

The nonprofit group Public Citizen says it is suing the FDA over the agency’s failure to take action on Serzone to “protect public safety and prevent needless death and injury.”

In the lawsuit, filed yesterday in Washington, D.C., the group claims that the FDA has “acted unlawfully” by not responding to the group’s petitions to withdraw the drug from the market.

Public Citizen first sought a ban on the drug in March 2003, citing 21 cases of liver failure and 11 deaths between 1994 (when Serzone was introduced) and the spring of 2002. A supplemental petition was filed in October 2003, which included accounts of 33 additional reports of liver failure, including nine deaths, filed with the FDA’s adverse event reports database from April 1, 2002, to May 12, 2003.

Serzone has already been taken off the market in Canada and Europe.

But the FDA has maintained that the risk of liver problems associated with Serzone is rare. In 2002, the agency added its strongest “black box” warning to the prescribing information for the drug, which details these risks.

According to the warning, the rate of liver failure in the U.S. is about one case of liver failure per 250,000-300,000 patient-years of treatment with Serzone. A patient year is a summary of patient exposure to the drug expressed in years. For example, one patient-year is equivalent to two patients treated for six months, three patients treated for four months, etc.

The drug’s manufacturer, Bristol-Meyers Squibb, says it is not directly involved in the lawsuit and cannot comment on it.

But company spokesman Robert Hutchinson says that since the black box warning was issued, “There has been no new data that would alter the risk-benefit of the product.”

Where Does Serzone Fit In?

Serzone doesn’t belong to the three most commonly used classes of antidepressants (cyclic, MAOI, or SSRI) and accounts for only a small share of antidepressants used in the U.S.

Psychiatrist Ivan Goldberg, MD, says Serzone is an interesting drug because it seems to have both antidepressant and anti-anxiety activity in the brain, but it hasn’t been proven to have any significant advantages over other types of antidepressants.

“The only possible advantage is that it may let you do some things with one medication rather than putting together a cocktail of two medications,” says Goldberg, who has a private practice in New York City.

He says there is probably little cause for concern for people currently using Serzone if they are not experiencing any symptoms of liver failure, such as:

Yellowing of the skin or whites of the eyes (jaundice)

• Loss of appetite that lasts for several days or longer

• Abdominal pain

• Unusually dark urine

• Nausea

If they are experiencing any of these symptoms, they should consult a doctor immediately.

“If they are doing well on it and have been taking it for longer than six months, there is probably no reason to even think of switching,” Goldberg tells WebMD. “Most of the people who have gotten into trouble on it have gotten into trouble within the first six months.”