UPDATE: Cymbalta Withdrawal MDL Denied for 2nd Time
October 12, 2015 — Federal judges denied a 2nd motion to centralize dozens of Cymbalta withdrawal lawsuits into a Multi-District Litigation (MDL) in one federal court. Click here to read more.
August 5, 2015 — The first lawsuit against Eli Lilly & Co. involving severe withdrawal symptoms of Cymbalta has gone to trial in California, with lawyers accusing the drug-maker of downplaying the risk. Click here to read more.
December 12, 2014 — Federal judges have refused plaintiffs’ request to centralize 25 lawsuits involving withdrawal side effects of Cymbalta into a Multi-District Litigation (MDL) under one judge. Instead, the cases will proceed individually. Click here to read more.
November 12, 2014 — A federal judge in New York has tossed a Cymbalta withdrawal lawsuit, ruling that the drug-maker adequately warned about the risk of severe withdrawal symptoms. The decision could hurt plaintiffs’ chances of consolidating dozens of similar lawsuits in federal court. Click here to read more.
September 15, 2014 — Law360.com reports that Eli Lilly & Co. has asked federal judges to deny a motion to centralize 28 lawsuits involving Cymbalya in a Multi-District Litigation (MDL). Click here to read more.
August 20, 2014 — Attorneys have asked a panel of judges to centralize 28 lawsuits involving severe withdrawal symptoms from Cymbalta into a Multi-District Litigation (MDL) in federal court in California. Click here to read more.
What is Cymbalta?
Cymbalta (duloxetine) is an oral medication that is primarily used to treat depression and anxiety. It was created by the drug company Eli Lilly & Co., and it was approved by the U.S. Food and Drug Administration (FDA) in 2004. Cymbalta is a type of antidepressant called an SNRI, or “serotonin-norepinephrine reuptake inhibitor,” which inhibits hormones and neurotransmitters in the brain that influence mood, emotions, and pain. Cymbalta has mild analgesic properties, and is also prescribed to treat diabetic neuropathy, osteoarthritis pain, and fibromyalgia.
Cymbalta Withdrawal Disorder
The link between Cymbalta and withdrawal was identified in the first clinical trials, before Cymbalta was approved by the FDA. Researchers from Eli Lilly & Co selected a group of patients with depression, who were given Cymbalta for 8-9 weeks. Then they were abruptly switched to a placebo and monitored another 1-2 weeks.
According to a report from the Institute for Safe Medicine Practices (ISMP), the study found that 44-50% of patients suffered withdrawal symptoms after discontinuing Cymbalta, of which 10% were “severe” symptoms. In nearly 54% of patients, the symptoms did not resolve after the 1-2 week monitoring period was over, and researchers did not follow-up beyond that period.
The medication guide does not state specifics about the risk of withdrawal. The label only includes this warning:
“Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.”
These warnings do not explain how often “other symptoms” occur, how severe these symptoms might be, or what a patient can do to minimize their risk of symptoms when they discontinue Cymbalta (such as gradually tapering off the dosage). In the ISMP QuarterWatch report for the first quarter of 2012, there FDA received 48 reports of withdrawal. According to the ISMP, “A major lapse has occurred in the FDA-approved information for patients about the risk of stopping duloxetine.”
The ISMP was also concerned that the clinical studies of withdrawal only lasted 8-9 weeks, when most people who use Cymbalta take it for many months or years before discontinuing the drug.
Symptoms of Cymbalta Withdrawal
The symptoms of Cymbalta withdrawal may include physical and neurological symptoms. Reported symptoms include:
- Dizziness (which may include severe vertigo)
- Nausea, vomiting
- Paresthesia (or “tingling” sensations, including sensations in the brain many patients refer to as “brain zaps”)
- Abnormal sweating
- Anger, irritability
- Suicidal ideation
- Personality changes
- Changes in weight / appetite
Cymbalta and Suicide
The FDA estimated that 4% of adolescents on antidepressants experienced suicidality, compared to 2% of patients on a placebo.
Soon after the boxed warning was added, Eli Lilly was hit with a lawsuit by the family of Paul Schilf, a 16 year-old who committed suicide on Christmas Eve after taking samples of Cymbalta for one month.
The Schilf family doctor said he was told no suicides occurred during clinical trials of Cymbalta, when in fact Eli Lilly concealed five completed suicides during a clinical trial sponsored by the drug-maker.
In 2007, the FDA asked drug-makers to strengthen warnings about suicide in young adults (18-24 years old) during the first 1-2 months of treatment.
Cymbalta Class Action Lawsuit Information
In January 2013, Law360 reported that Eli Lilly & Co. asked a federal judge in California to toss a Cymbalta class action lawsuit. The class action sought compensation on behalf of everyone in California who purchased Cymbalta without adequate warnings about the risk of withdrawal symptoms, including “brain zaps.”
Our attorneys are not filing a Cymbalta class action — instead, we are reviewing cases and filing individual claims on behalf of people who were severely injured by Cymbalta. Contact us today for more information.