Serzone and Nefazadone: News, Research, and Litigation

Bristol Myers Squibb introduced Serzone (nefazodone) to the market in 1994. This is the year the U.S. Food and Drug Administration (FDA) first approved the drug. Serzone was an antidepressant drug that doctors prescribed to treat major depressive disorder and anxiety.

Serzone was not a selective serotonin reuptake inhibitor (SSRI) like most antidepressants. So, the drug manufacturer promised it wouldn't cause as much weight gain as other antidepressants.

The drug is no longer on the market. In 2004, the drug manufacturer discontinued the medication. The company had already discontinued the prescription drug in Australia, Europe, and Canada.

Bristol Myers Squibb said it was discontinuing the drug for business reasons. But many in the healthcare community suspected that they had pulled the drug for other reasons—namely, the high rate of liver damage and liver failure in patients taking Serzone.

The generic version of the drug, nefazodone, is still available in America. Teva markets the generic version. Thousands of Americans take nefazodone even though studies show that it may also cause liver failure.

Here, we offer a brief history of Serzone, including its serious side effects and health risks. We also discuss why the drug company may have stopped selling this drug. Finally, we explain what to do if you become sick after taking nefazodone or any other antidepressant medication.

January 2002: FDA Requires New Black Box Warning on Serzone

In January 2002, the FDA ordered Bristol Myers Squibb to add a black box warning to its Serzone packaging. According to the FDA, clinical trials showed an increased risk of liver failure in patients taking Serzone. The FDA told the drugmaker to include language on the drug's label about the increased risk of liver failure.

One of the studies the FDA used when determining the need for a new warning found that people taking Serzone were three or four times more likely to develop liver disease. This is as compared to patients taking a placebo. More than 15% of the patients suffering from liver disease needed a liver transplant. Many of these patients died as a result of taking Serzone.

March 22, 2004: FDA Asks Antidepressant Manufacturers To Advise Observation of Patients

The FDA issued a Public Health Advisory asking manufacturers of antidepressants (including Serzone, Prozac, Zoloft, Paxil, and more) to add warnings to their drugs' packaging.

Specifically, the FDA wanted the drugmakers to include a statement recommending close observation of adult and child users of the medication. The FDA told patients taking the drug to look for signs of increased depression or suicidal thoughts and behavior.

March 15, 2004: Public Citizen Group Sues FDA Over Failure to Ban Serzone

Public Citizen sued the FDA for failing to act on the group's petition to ban Serzone. The lawsuit asked the court to find the FDA's failure to act illegal. It also asked the courts to require the agency to take regulatory action against the manufacturer of Serzone and nefazodone.

May 19, 2004: Bristol Myers Squibb Announces U.S. Sales of Serzone to End in June

Bristol Myers Squibb announced it would no longer sell Serzone in the U.S. after June 14, 2004. A company spokesperson indicated they decided to withdraw the drug from the market due to declining sales, not safety issues.

2005: Thousands of Patients Sue Bristol Myers Squibb Over Serzone

In 2005, thousands of plaintiffs filed suit against Bristol Myers Squibb in the Southern District Court of West Virginia. The plaintiffs' product liability attorneys alleged that Serzone caused acute liver injury and death in their clients.

The class action lawsuit settled for more than $70 million. But more than 2,500 plaintiffs chose to opt out of the settlement and continued their cases against the drug manufacturer.

Is the Generic Version of Serzone Dangerous?

Many people wonder why the generic version of Serzone is still on the market. They assume that Bristol Myers Squibb discontinued the drug for safety reasons. But the company and the FDA confirmed that this wasn't the case. They stopped selling the drug because it was no longer profitable.

You may wonder if Nefazodone is as dangerous as Serzone. This is a good question. There is evidence that the generic drug does increase your chances of developing liver failure. The drug works by increasing the production of certain enzymes to help regulate mood.

In a 2020 study, researchers found that nefazodone posed severe health risks. These health risks and adverse side effects include the following:

• Serotonin syndrome
• Glaucoma
• Angioedema
• Stevens-Johnson syndrome
• Seizures
• Suicidal thoughts and behaviors in children and adolescents
• Increased manic episodes
• Increased incidence of acute liver injury and death

While nefazodone is still available, few healthcare professionals prescribe it. Prescribing clinicians use it as a last-resort treatment of depression and other mental health disorders. Many new drugs have arrived on the market since the FDA approved nefazodone more than 30 years ago.

What To Do if You Become Sick After Taking Nefazodone

If you or a loved one becomes sick after taking nefazodone or any antidepressant, seek immediate medical attention. Some side effects and adverse events of this drug are so severe that they require hospitalization.

Once you confirm your injuries, contact an experienced product liability attorney. They can review your case and tell you if you have a valid claim. Remember that the statute of limitations period to sue for injuries from taking Serzone has passed. But you can pursue legal action if you become sick after taking nefazodone.

Visit FindLaw.com's attorney directory to find a product liability lawyer near you.