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A federal judge has cleared the way for a lawsuit to move forward involving claims that side effects of Abilify may cause involuntary muscle movements, known as tardive dyskinesia.
U.S. District Judge Eldon Fallon issued an order (PDF) on August 21, denying a request by the drug makers Bristol-Myers Squibb and Otsuka America Pharmaceutical Inc. to dismiss a failure to warn lawsuit filed by Cory P. Jenkins, who was diagnosed with tardive dyskinesia following Abilify use.
Tardive dyskinesia is a disorder that causes repetitive and involuntary movement, usually involving the lower face and limbs. Symptoms can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the disorder, and the abnormal movements can become permanent, persisting even after use of the drug has stopped.
According to allegations raised in the complaint (PDF) filed by Jenkins pending in the U.S. District Court for the Eastern District of Louisiana, he developed “chronic and continued restlessness and twitching of the upper and lower extremities, facial tics, jaw clenching and clucking, and constant eye blinking” in 2013, after taking the antidepressant.
Jenkins asserted two separate theories of liability, including defective design and failure to warn about the Abilify tardive dyskinesia risk.
In a motion to dismiss filed by Bristol-Myers Squibb and Otsuka, the drug makers argue that the defective design claims fail to allege that there was a safer alternative design. In addition, the defendants maintained that the failure to warn claims should be dismissed because Jenkins failed to allege that his treating physician would not have prescribed the drug if different warnings had been provided.
While Judge Fallon did dismiss the design defect claim, he rejected the request to dismiss the failure to warn claim, allowing the tardive dyskinesia lawsuit over Abilify to move forward.
“Plaintiff is merely required to allege that Defendants did not adequately warn Plaintiff’s treating physician and that the inadequate warning constituted the proximate warning of Plaintiff’s injuries,” Judge Fallon ruled. “[T]he Court finds that Plaintiff’s failure-to-warn claim satisfies this standard and is sufficient to survive Defendant’s … motion.”
Abilify Side Effects
Abilify (aripiprazole) was approved by the FDA in 2002, and is one of the top selling drugs in the U.S., generating sales of $7.5 billion in 2013.
In addition to concerns about the risk of tardive dyskinesia, Abilify has also been linked to reports of impulse control problems, including gambling addictions, sex addictions and other similar behavior that has been linked to a class of drugs known as dopamine receptor agonists.
A recent study by the Institute for Safe Medication Practices, published in the medical journal JAMA Internal Medicine, found that this class of drugs was linked to impulse control problems, such as compulsive gambling, sex addiction and other issues that may have a severe impact on an individual’s life.
There are six FDA-approved dopamine agonists currently on the market in the United States. The Parkinson’s disease drugs Mirapex and Requip were most strongly linked to incidents of impulse control problems among the dopamine receptor agonists, leading to gambling addictions and hypersexuality, and even compulsive shopping. However, a safety signal was also seen for Abilify gambling and impulse control problems, with at least 37 reports found specifically involving this one medication.
Researchers have warned that drug manufacturers failed to provide adequate warnings about the risk of impulsive behavior on the drugs, indicating that information about the risk dates back to at least 2009, when a study found that approximately 18% of patients taking a dopamine agonist for treatment of Parkinsons disease could suffer from compulsive behavior side effects.
Although Abilify is a partial dopamine receptor agonists, researchers found that the same signals for gambling and other impulse control problems with Abilify were seen among users of the antipsychotic medication as well.