By Barbara Martinez of The Wall Street Journal
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.
Bristol-Myers Squibb 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 has a role in the U.S. in people that couldn’t use” other medications.
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 records 20 deaths I the U.S. from liver failure in people using Serzone, including a six-year-old child. Dr. Wolfe said the 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 that 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 reason.”
“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 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 NCDHealth, sales of 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.