Serzone / Nefazodone Hydrochloride

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Modified on 2009/10/14 21:33 by admin
In May 2004, Bristol-Myers Squibb pulled Serzone off the U.S. market citing diminished sales. Distribution ended on June 14, 2004. While the company insists the decision was based solely on decreased revenue, skeptics believe mounting lawsuits over the drug's link to dozens of cases of liver failure and liver toxicity forced Bristol-Myers to discontinue Serzone.

Serzone, also known as nefazodone hydrochloride, belongs to a class of medications known as antidepressants. Manufactured by Bristol-Meyers Squibb Company, Serzone fights mental depression by increasing natural substances in the brain. The U.S. Food and Drug Administration approved Serzone in 1994.

Side effects of Serzone use include, but may not be limited to, blurry vision, skin rash or itching, lightheadedness, ringing in the ears, dry mouth, nausea and fatigue.

In December 2001, the FDA ordered Bristol-Meyers to include a so-called "black box warning" on Serzone's label. The new Serzone side effects label states that "cases of life-threatening hepatic failure have been reported in patients treated with Serzone. This represents a rate of about 3-4 times the estimated background rate of liver failure. This rate is an underestimate because of under reporting, and the true risk could be considerably greater than this."

In January 2003, Bristol-Myers Squibb pulled Serzone from the European market because of its link to 25 reports of liver failure and 18 deaths.

Serzone has not undergone testing for efficacy and safety in children. Currently, no studies exist comparing use of Serzone in children up to 18 years of age with use in other age groups. The medication, however, has been prescribed to children despite a lack of evidence that the drug is safe. In fact, several patients, including children, have experienced liver failure as well as jaundice and hepatitis after taking Serzone. Many of these patients have required liver transplants in order to survive.

Researchers have linked concurrent use of Serzone and Zocor to the development of rhabdomyolysis. A March 2003 article, written by physicians at the University of Cincinnati College of Medicine and published in John Hopkins University's Advanced Studies in Medicine, discussed three recent cases of rhabdomyolysis in patients who had undergone concomitant use of Serzone and Zocor.

In October 2003, the FDA notified healthcare professionals of reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). FDA has completed a preliminary review of such reports for 8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied under the pediatric exclusivity provision, and has determined that additional data and analysis, and also a public discussion of available data, are needed.

In November 2003, Health Canada, a federal department responsible for Canada's health care system, announced that all generic medications containing nefazodone were being pulled from the market because of the drug's link to severe liver disease.

In January 2004, Bristol-Myers Squibb pulled Serzone from the Australian market citing diminished sales.

In March 2004, the Food and Drug Administration issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.

FDA is asking manufacturers to change the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine. It should be noted that the only drug that has received approval for use in children with major depressive disorder is fluoxetine (Prozac). Several of these drugs are approved for the treatment of obsessive-compulsive disorder in pediatric patients, i.e., sertraline (Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not approved as an antidepressant in the United States.

In May 2004, Bristol-Myers Squibb pulled Serzone off the U.S. market citing diminished sales. Distribution ended on June 14, 2004. While the company insists the decision was based solely on decreased revenue, skeptics believe mounting lawsuits over the drug's link to dozens of cases of liver failure and liver toxicity forced Bristol-Myers to discontinue Serzone.

See your doctor if you have experienced serious side effects associated with Serzone. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.



See Also

  1. Antidepressants & Other Psychiatric Drugs
  2. Fatigue: Overview
  3. Hepatitis: Overview
  4. Jaundice
  5. Liver Failure: Overview
  6. Nausea: Overview
  7. Priapism: Overview
  8. Rhabdomyolysis
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