SERZONE

The anti-depressant, Serzone, is made and marketed by Bristol-Myers Squibb Co. Its generic name is nefazodone hydrochloride. Since approval by the FDA in 1994, it has been used by more than 7.2 million patients in the United States alone. It works by blocking the body’s absorption of the mood-regulating hormones, serotonin and norepinephrine. Although its structure and composition put Serzone in a class all its own, it does bear some similarity to Prozac, Paxil, Zoloft and other drugs collectively known as selective serotonin reuptake inhibitors (SSRIs).
The FDA now estimates that Serzone linked to one liver failure that results in a transplant or death for every 250,000 to 300,000 patient-years of treatment. (Each patient-year is equivalent to one patient taking the drug for one year, or two patients each taking it for six months, etc.)

This rate is three to four times higher than normal, and the FDA says the drug-induced failure rate may be even higher due to under-reporting. That’s because the FDA gets reports of deaths and adverse reactions from voluntary submissions by physicians and hospitals. (Drug manufacturers, however, are required to make such reports, but they don’t always know of the adverse effects caused by their products and don’t always comply with the requirement when they do know. See “Meridia,” below.) Thus, the number of actual adverse reactions is typically thought to be 10 times higher than reported. As drug companies like to point out, however, listing a death in the FDA’s files means the drug is suspected, not that is it proven that it caused death.

Doctors are being advised to err on the side of caution by monitoring liver functioning in all patients for whom they prescribe Serzone, and to take them off the drug and keep them off - at the first sight of trouble. Because many more patients will develop transient symptoms rather than full blown jaundice, this means the drug probably may sometimes be withheld unnecessarily, but the precaution is prudent because of the inability to predict which patients are at risk of a severe reaction to the drug. Dire consequences that can arise from that reaction as about 10 percent of all types of drug-induced liver inflammation end in death.