Almost two-dozen consumers who suffered moderate to severe side effects when they tried to stop using the antidepressant Cymbalta have recently sued drug maker, Eli Lilly & Company. The plaintiffs claim the company knew the drug caused withdrawal symptoms in almost half of those who discontinued use of the drug, but significantly downplayed the risks in warning labels.
Although the symptoms of Cymbalta withdrawal have become well documented by the U.S. Food and Drug Administration (FDA), Eli Lilly has not acknowledged that the risk of withdrawal symptoms is severe in its marketing campaigns or drug warnings. As of 2011, Eli Lilly’s Cymbalta label reads, “symptoms occurred at a greater rate than or equal to 1%” of users—a warning that, while technically is true, makes it easy for Cymbalta users and health care professionals to be unaware that symptoms were present in 44-50 percent of users.
Although the label does list the many potential symptoms of Cymbalta withdrawal, it is notably unclear on how frequent these symptoms occur to the point where plaintiffs in lawsuits against the company claim that they were mislead into thinking the drug came with little risk.
Physicians nor patients expected the severity of withdrawal from Cymbalta. in fact, it’s bad enough to warrant its own diagnosis—Cymbalta Discontinuation Syndrome. An FDA advisory committee report about Cymbalta Discontinuation Syndrome states, “Much anecdotal evidence has accumulated documenting the injury, distress and life management impacts caused by discontinuation of Cymbalta. The effects of discontinuation can be severe and extend for weeks or even months.”
Many plaintiffs are asking Lilly to add stronger warnings about “brain zaps” and other side effects, including dizziness, nausea, fatigue, headaches, vomiting, irritability, nightmares, insomnia, diarrhea, paranoia, anxiety, agitation, profuse sweating, and vertigo.
Lilly has already tried to dismiss a class action, claiming the Prescribing Information warns doctors that withdrawal “occurred at a rate greater than or equal to 1 percent.” In clinical trials, withdrawal occurred in about 50% of people who abruptly discontinued Cymbalta, and 10% of cases were severe.
Cymbalta is marketed as a treatment for depression, anxiety, fibromyalgia, and even muscular or skeletal pain. This is not the first time Eli Lilly has been accused of misleading marketing techniques. They have a history of attracting the attention of the FDA and other medical professionals before:
- In 2009 Eli Lilly was criminally prosecuted by the US Department of Justice for concealing the adverse side effects of its anti-psychotic drug Zyprexa for which they pled guilty and settled for more than $1.5 billion.
- In 2007, the FDA penalized Lilly for unlawfully promoting Cymbalta products through direct mailings. The FDA issued the penalty because Lilly’s ad was “false or misleading [and] overstated the efficacy of Cymbalta.” The FDA penalty also cited Lilly’s failure to reveal material facts including precautions relating to abrupt discontinuation of Cymbalta.
- Lilly was again penalized in 2009 for illegally marketing Cymbalta by failing to include relevant risk information of side effects associated with use of the drug.
Eli Lilly & Company has developed a documented history of misleading (or potentially misleading) marketing campaigns that both overstate the effect of Cymbalta and downplay the risks. With the drug being marketed aggressively on television ads, online advertising and mailers, users have been exposed to significant advertisements that may not provide the facts regarding Cymbalta withdrawal symptoms.
As far as suicide lawsuits, the FDA issued a warning about the potential for suicidal thinking in adults taking antidepressants, but the agency specifically singled out Cymbalta because of a higher than expected rate of suicide attempts in recent studies.
A recent lawsuit against Eli Lilly & Company alleges that the manufacturer had conducted internal clinical tests to determine that the risk of Cymbalta withdrawal symptoms was between 44-50%, with up to 30% of patients experiencing “moderate to severe” symptoms. The results of these clinical trials were submitted to the FDA in 2004 when the company was attempting to receive drug approval, however, these results were not made clear via drug labels or warnings in marketing campaigns.
In addition, Lilly has also been accused of selectively publishing studies and clinical test results to present a favorable impression that Cymbalta users were at a very low risk for withdrawal symptoms.
The FDA has acknowledged “a serious breakdown at both the FDA and the manufacturer, Eli Lilly and Company, in providing adequate warnings and instructions about how to manage [the side effects],” indicating that Lilly was aware of the severity of the risks and downplayed the side effects in its marketing campaigns and warning labels.
Lawsuits allege Cymbalta marketing has been misleading and failed to adequately warn patients of the drug’s risks and addictive qualities. The degree to which Lilly was aware of the drug’s risks and hid the facts through misleading marketing campaigns can be a significant factor in the right of Cymbalta victims to recover financial damages for pain and suffering.
If you or a loved one suffered from Cymbalta withdrawal, contact one of our experienced Gacovino Lake attorneys at 1-800-246-HURT (4878) for a free consultation.