{"id":353363,"date":"2016-04-04T10:46:52","date_gmt":"2016-04-04T15:46:52","guid":{"rendered":"https:\/\/ability-fl-prod.internetbrands.com\/ability-law\/injury\/product-liability\/serzone-recent-news.html"},"modified":"2024-02-12T11:45:38","modified_gmt":"2024-02-12T16:45:38","slug":"serzone-recent-news","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/serzone-recent-news.html","title":{"rendered":"Serzone and Nefazadone: News, Research, and Litigation"},"content":{"rendered":"\n
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Serzone and Nefazadone: News, Research, and Litigation<\/h1>\n\n
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\n By Christie Nicholson, J.D.<\/a> | Legally reviewed by Oni Harton, J.D.<\/a>\n | Last updated\n
\n \n <\/i>\n Legally Reviewed\n <\/summary>\n\n
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This article has been written and reviewed for legal accuracy, clarity, and style by FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with our editorial standards<\/a>.<\/em><\/p>\n\n <\/div>\n <\/details>\n\n

\n \n <\/i>\n Fact-Checked\n <\/summary>\n\n
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The last updated date refers to the last time this article was reviewed by FindLaw or one of our contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please contact an attorney in your area<\/a>.<\/em><\/p>\n\n <\/div>\n <\/details>\n<\/section>\n\n\n

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Key Takeaways<\/h2>\n
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Serzone was discontinued by the manufacturer in 2004 for business reasons. The drug faced growing concerns over liver toxicity, prompting FDA warnings and legal action. Although the brand name is no longer on the market, the generic version remains available and continues to prompt safety concerns and legal action.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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Bristol Myers Squibb (BMS) introduced Serzone (nefazodone)\u00a0to 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.<\/p>\n

Serzone<\/a> 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.<\/p>\n

The drug manufacturer discontinued the medication in 2004.<\/a> Prior to this, BMS had already pulled the prescription drug in Australia, Europe, and Canada.<\/p>\n

BMS stated it was pulling the drug from the market for business reasons. But many in the healthcare community suspected that they had pulled the drug for other reasons\u2014namely, the high rate of liver damage and liver failure in patients taking Serzone.<\/p>\n

The generic version of the drug, nefazodone, is still available in America. Teva markets the generic version. Thousands of Americans take nefazodone even though\u00a0studies\u00a0show that it may also cause liver failure<\/a>.<\/p>\n

This article provides news updates regarding Serzone and nefazodone, including research and litigation involving the drug. You’ll also learn what to do if you develop an illness after taking nefazodone or another antidepressant medication.<\/p>\n

A product liability attorney<\/a> near you can also answer your questions and provide targeted legal advice. They can evaluate your situation, explain your legal options, and recommend next steps.<\/p>\n

January 2002: FDA Requires New Black Box Warning on Serzone<\/h2>\n

In January 2002, the FDA ordered Bristol Myers Squibb to add a\u00a0black box warning<\/a>\u00a0to 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.<\/p>\n

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.<\/p>\n

March 22, 2004: FDA Asks Antidepressant Manufacturers To Advise Observation of Patients<\/h2>\n

The FDA issued a\u00a0Public Health Advisory<\/a>\u00a0asking manufacturers of antidepressants (including Serzone, Prozac, Zoloft, Paxil, and more) to add warnings to their drugs’ packaging.<\/p>\n

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.<\/p>\n

March 15, 2004: Public Citizen Group Sues FDA Over Failure to Ban Serzone<\/h2>\n

Public Citizen<\/a>\u00a0sued 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.<\/p>\n

May 19, 2004: Bristol Myers Squibb Announces U.S. Sales of Serzone to End in June<\/h2>\n

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.<\/p>\n

2005: Thousands of Patients Sue Bristol Myers Squibb Over Serzone<\/h2>\n

In 2005, thousands of plaintiffs filed suit against Bristol Myers Squibb in the\u00a0Southern District Court of West Virginia<\/a>. The plaintiffs’ product liability attorneys alleged that Serzone caused acute liver injury and death in their clients.<\/p>\n

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.<\/p>\n

Is the Generic Version of Serzone Dangerous?<\/h2>\n

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.<\/p>\n

You may wonder if Nefazodone is as dangerous as Serzone. 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.<\/p>\n

In a\u00a02020 study<\/a>, researchers found that nefazodone posed severe health risks. These health risks and adverse side effects include the following:<\/p>\n