Eli Lilly & Co., the producer of the popular antidepressant Cymbalta (duloxetine), is facing a spate of litigation over injuries associated with the drug. Plaintiffs allege that Cymbalta can cause severe withdrawal symptoms, including dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis, and vertigo within 12 hours of missing a single dose. Over 28 lawsuits have now been filed before 22 district courts and 21 different judges. Attorneys for the plaintiffs have now asked the Judicial Panel on Multidistrict Litigation (JPML) to consolidate these actions in a California federal court.
The petition filed with the JPML states that “it is likely that many hundreds of cases will be filed during the course of this litigation.” This expected amount of cases with similar facts and injuries generally warrant the creation of a Multidistrict Litigation (MDL) in order to increase the efficiency of pretrial proceedings. In an MDL, discovery and pretrial proceedings affect all cases in the MDL, leading to reduced costs for both parties, as well as consistent rulings from the Court.
Cymbalta was approved by the FDA in 2004 for the treatment of major depressive order. It was later approved in 2007 for the treatment of generalized anxiety disorder, and in 2008, for the treatment of fibromyalgia. Eli Lilly has also been accused by Plaintiffs of marketing the drug with overstated efficacy rates and understated withdrawal effects.
In fact, Eli Lilly’s own clinical studies show that at least 44.3% of Cymbalta patients exhibited side effects when they stopped taking the drug. Despite this finding, the label for Cymbalta clearly states that these withdrawal symptoms are rare and only effect 1% of users. Plaintiffs also allege that Eli Lilly’s usage of the word “discontinuation” instead of “withdrawal” when describing the effects of withdrawal from Cymbalta shows the company’s gross understatement of the side effects of Cymbalta.
Effects of Withdrawal
The effects of Cymbalta withdrawal can be very painful and disturbing for many victims of the drug. Some patients describe “brain zaps” which literally feel like the brain has been shocked. This side effect is often accompanied by severe dizziness and is seemingly random. Others report suicidal ideation, insomnia, and painful headaches. The withdrawals can last for several months.
What could cause such atypical withdrawal effects? Well, Cymbalta is not a typical antidepressant. Many older antidepressants are selective serotonin reuptake inhibitors (SSRI), like Prozac and Paxil. These drugs inhibit the reuptake of serotonin, a neurotransmitter in the brain which affects mood. SSRIs come with their own dangers and tolerability issues, but are older and better established. On the other hand, Cymbalta is in a class of drugs called selective serotonin-norepinephrine reuptake inhibitors (SNRIs) which are newer and less studied. Eli Lilly even admits (along with other SNRI manufacturers) that the precise mechanism of action for this class of drugs is not clear.
Cymbalta was only created after Eli Lilly’s patent on Prozac expired. Prozac has a very long half-life (the time it takes for the drug to be eliminated from the body) which Eli Lilly argued contributed to its low withdrawal rates. Cymbalta, on the other hand, is eliminated quickly from the body, which could be the cause of its more severe side effects from withdrawal.
Although these cases are still in the early stages of litigation, we do hope that the victims of this dangerous drug achieve the justice they deserve. Big pharmaceutical companies too often understate or downplay the risks of their drugs despite evidence to the contrary. Patients need to be informed of all of the risks before they put an unknown substance into their body.