- The Washington Times - Thursday, March 6, 2003

WASHINGTON, March 6 (UPI) — A consumer advocacy group Thursday filed a petition with the Food and Drug Administration requesting an anti-depressant drug be taken off the market because it can cause liver failure and death.

The drug, Serzone, which has been available to U.S. consumers since 1994 for the treatment of depression, has been associated with 28 cases of liver failure, including 18 deaths worldwide, according to the manufacturer Bristol-Myers Squibb. Some of these cases have required liver transplants.

"There is no good reason to keep this drug on the market," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, which filed the FDA petition, said in a written statement. "It is no more effective than other antidepressants, and it presents a unique health hazard for patients."

Public Citizen said it analyzed reports form the FDA and found 53 cases of liver injury, including 21 cases of liver failure and 11 deaths in the United States since 1994.

The number of cases probably is higher, Wolfe told United Press International, because the FDA has not provided data for the latter half of 2002. "The FDA has more data than we have and it is likely that more (adverse events) occurred after we stopped getting data from them," he said.

Serzone currently comes with a black box warning — the FDA's most serious warning for a drug — placed at the beginning of labeling that cautions about the possibility of "life-threatening (liver) failure."

Responding to Public Citizen's petition, Bristol-Myers Squibb maintained Serzone was safe.

The company put the black box warning on the drug's labeling in December, 2001, to notify doctors and patients of the risk of liver failure and since then "there has been no change in the rate of confirmed clinical reports of cases of acute liver failure leading to transplantation and/or death associated with Serzone," spokeswoman Julie Keenan told UPI.

In addition, there has not been "any new data that would alter the risk /benefit assessment," she said.

Wolfe said that was untrue because he had reports from the FDA showing that at least two people taking Serzone had been hospitalized last year after the black box warning was put on labeling. In addition, he said, the black box warning will do little to curtail the incidence of liver failure associated with the drug.

"There's no evidence that for liver damage black box warnings work," Wolfe said. The FDA tried it for two other drugs but those eventually had to be taken off the market, he said.

According to the separate warnings section of Serzone labeling, the rate of cases of liver failure resulting in death or the need for a liver transplant in patients taking Serzone is three-to-four times higher than that seen in the general population.

The labeling further states, "This rate is an underestimate because of under reporting, and the true risk could be considerably greater than this."

However, it adds, "A large cohort study of antidepressant users found no cases of liver failure leading to death or transplant among Serzone users in about 30,000 patient-years of exposure."

In January, BMS stopped selling the drug in several European countries. Public Citizen claims this was due to pressure from Sweden to place a warning label on the product about the possibility of liver failure.

Keenan, however, said the decision was due to "a low rate of prescribing use from several EU countries." She noted the product in Sweden carried a warning label about the liver problems "for years" prior to the company's decision to remove it from the market.

The Swedish government requested BMS instituted a program to monitor liver function in patients taking Serzone, Keenan said.

"In the absence of any clinical studies to suggest that a monitoring program can prevent those rare cases of idosyncratic liver failure … we chose, in light of the low rate of prescribing use, to remove it from the market," she said.

FDA spokeswoman Susan Cruzan told UPI: "FDA will review the petition and will respond accordingly."

Keenan said BMS had no plans "at this time … to discontinue sales in the U.S." In addition to the U.S., Serzone is available in Canada, Australia, Asia and Latin America, she said.

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