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SERZONE/ NEFAZODONE INFO - NEW FOR US USERS

Posted by Tony C. on June 15, 2004, at 14:07:45

Prescription changes loom after Serzone demise

As Bristol-Myers Squibb Co. (BMS) prepares to pull brand-name nefazodone off the market, many patients will have to start taking generic equivalents or change antidepressants.

"I have several patients on (nefazodone) who read the news reports and were concerned because it is the only antidepressant that has helped them," said Anthony Rothschild, MD, director of clinical research, department of psychiatry, University of Massachusetts Medical School. "These patients have been on it for years, and we check their liver function tests."

On June 14, BMS will stop making and selling nefazodone in the United States. The agent has been associated with liver damage and at least 20 deaths, and BMS is defending several lawsuits stemming from nefazodone therapy.

However, BMS spokesman Rob Hutchison says poor sales—not the side-effect risk—have spurred BMS' decision. He said that sales of the company's brand-name product, Serzone, have dropped precipitously since last fall, when its patent expired. Several generic equivalents are now available, Hutchison said.

FDA-approved in 1995, nefazodone has been used primarily as a second- or third-line antidepressant. W. Victor R. Vieweg, MD, professor of psychiatry and internal medicine, Medical College of Virginia, Virginia Commonwealth University, notes that psychiatrists have chosen nefazodone in many cases because of its sedating properties, efficacy in depression-related anxiety, and lack of sexual side effects.

"Patients currently taking Serzone will have to change to another antidepressant," Dr. Vieweg said. "They will be the ones most inconvenienced."

But Gordon Johnston, vice president of regulatory affairs for the Generic Pharmaceutical Association (Arlington, VA), said that as many as eight companies are manufacturing generic nefazodone.


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poster:Tony C. thread:356940
URL: http://www.dr-bob.org/babble/20040614/msgs/356940.html