Drug Safety Developments

Settlements Reached for First Round of Abilify Gambling Lawsuits

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

Background

In May 2016, the U.S. Food and Drug Administration (FDA) released a Drug Safety Communication concerning the antipsychotic drugs, Abilify, Abilify Maintena, and Aristada.

This safety announcement provided the following warning:

The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk that we identified. In addition, we have become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, we are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

 

Lawsuits

Since the FDA's warning, over 800 Abilify lawsuits have been filed against the drug manufacturers, Bristol-Myers Squibb and Otsuka Pharmaceuticals.  These cases involve Plaintiffs who used Abilify, then experienced the harmful compulsory behaviors that the FDA warned about in May 2016. 

The Plaintiffs argue that the manufacturers of Abilify, Abilify Maintena, and Aristada should have known and warned about the link between their drugs and the harmful, uncontrollable urges.  If such warnings had been provided by the drug manufacturers, then the Plaintiffs claim that they would have recognized the causes of such urges and been able to seek medical help before undergoing such devastating losses.

These Abilify cases have been consolidated in the multidistrict litigation (MDL) in the Northern District of Florida.  An MDL is often created in order to centralize cases that involve the same defendants and issues.

Three test cases out of this MDL were selected by the involved parties and the judge presiding over the MDL to go to trial in June of this year.  However, these cases were recently settled after a successful mediation.  According to the Order signed by the MDL judge, once the settlement money is paid by the Defendants and dismissals are signed by the Plaintiffs, the cases will officially be taken off the trial docket.

 

Going Forward

Often times, the test cases in an MDL -- often referred to as "bellwether trials" -- will determine rulings for the remaining cases in the MDL.  Given that the original cases never went to trial, a new round of test cases will be selected.  If the second round of cases is again settled before going to trial, one could predict that the cases remaining in the MDL could also anticipate settlements instead of trial dates.

We will continue to monitor the legal news for updates on the Abilify gambling lawsuits and report significant developments as we are made aware of them.

 

 

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FDA Warns of Uncontrollable Behaviors Observed During Abilify Use

 

Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.

 

The FDA recently released a Drug Safety Communication concerning aripiprazole, which is found in popular antipsychotic drugs, Abilify, Abilify Maintena, and Aristada.  This FDA article warned of possible "compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex" among adults and children taking one of the aforementioned aripiprazole drugs.

This warning was based on the 184 case reports involving these aripiprazole drugs and impulse-control problems, of which 167 occurred in the United States.  

According to the reported cases from the past 13 years, pathological gambling was the most common uncontrollable behavior observed, but other impulsive urges -- including compulsive eating, spending or shopping, and sexual behaviors -- were also reported.

Of note, such impulsive behaviors were not previously observed in the patients, and reportedly ceased after the patient stopped taking Abilify, Abilify Maintena, or Aristada, or once they had their dose reduced.

We get this additional information from the Medpage Today article, FDA Warning: Abilify Tied to Impulse Control Problems:

The FDA did not identify a specific mechanism to account for these effects, but it hinted at one: Aripiprazole is unique among atypical antipsychotics in that, whereas others in the class are strong blockers of dopamine receptors in the central nervous system, aripiprazole is only a partial blocker, the agency said.

Though the FDA drug label for Abilify currently lists "pathological gambling" as a possible side effect, the FDA states that "this description does not entirely reflect the nature of the impulse-control risk that [they] identified."  Additionally, they "are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products," in order to more adequately warn of such side negative effects.

The FDA further cautions that such uncontrollable behaviors "may result in harm to the patient and others if not recognized."  As such, the FDA advises patients and caregivers to "be alert for uncontrollable and excessive urges and behaviors" while taking Abilify, Abilify Maintena, or Aristada.  They also state that "patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional."

We will continue to watch for the revised drug labels and Medication Guides for Abilify, Abilify Maintena, and Aristada, and report on any new developments concerning these drugs.

 

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UK study links antipsychotic drugs to clot risk

Quoted from http://www.reuters.com/article/idCNLDE68K0XS20100921

UK study links antipsychotic drugs to clot risk

Tue Sep 21, 2010 7:01pm EDT

 

By Ben Hirschler

LONDON, Sept 22 (Reuters) - Modern antipsychotic drugs, especially AstraZeneca's (AZN.L) blockbuster Seroquel, may increase the risk of patients developing life-threatening blood clots, British researchers said on Wednesday.

The finding, from a trawl of tens of thousands of patient records, adds to a growing body of evidence linking so-called atypical antipsychotics to adverse side effects.

Atypicals -- which also include Eli Lilly's (LLY.N) Zyprexa, Johnson & Johnson's (JNJ.N) Risperdal and Bristol-Myers Squibb's (BMY.N) Abilify -- dominate the antipsychotic market, which had sales of $16 billion in 2009, according to Thomson Reuters data.

First introduced more than 20 years ago, such drugs cause fewer of the involuntary-movement problems associated with older medicines but have been linked to diabetes and increased mortality in people with dementia.

There has also been limited evidence linking them with dangerous blood clots, such as deep vein thrombosis and pulmonary embolism, although previous studies have been small.

The large British study, which compared 25,000 cases of patients with venous thromboembolism (VTE) against 89,000 controls, found people prescribed antipsychotics had a 32 percent greater risk of serious blood clots, after adjusting for other potential risk factors.

 

The risk was greater for people on atypical drugs, rather than older ones, and the highest risk was seen with Seroquel, which showed a nearly three times increase on an adjusted basis.

[Article continues at original source]

US FDA panel has child weight concerns about drug

Quoted from http://www.reuters.com/article/idUSN0822035720091208

US FDA panel has child weight concerns about drug

 

ROCKVILLE, Md., Dec 8 (Reuters) - A U.S. drug regulatory advisory panel said on Tuesday current labeling for pediatric uses of Bristol-Myers Squibb Co's antipsychotic drug, Abilify, does not adequately warn of the risk of excessive weight gain.

The panel also recommended they continue to monitor pediatric use of the drug, known by the generic name of aripiprazole.

The panel voted 12-0 that the current label was inadequate and FDA staff were to work on a revised label, which staff said might include moving all information on metabolic effects of the drug in children to the warning section. Other metabolic effects could include development of type 2 diabetes or metabolic syndrome.

Abilify is used to treat schizophrenia and bipolar disorder.

Hefty Side Effect For Kids On Antipsychotics

Quoted from http://www.forbes.com/2009/10/27/antipsychotics-lilly-astrazeneca-business-healthcare-children.html

Hefty Side Effect For Kids On Antipsychotics

Robert Langreth, 10.27.09, 04:50 PM EDT

Study finds troubling weight gains in children taking brand-name psychiatric drugs.

A new study is likely to add to the furious debate over the rapid rise in the prescription of heavy-duty antipsychotic drugs to children. It found that kids' weight balloons by 10 to 19 pounds in just the first three months on the drugs, often leading to worrisome elevations of cholesterol, triglycerides and other metabolic parameters.

Weight gain is a known side effect of the drugs, but the new study is notable because it found far greater increases than had been seen in many previous trials. Researchers tracked 272 children between the ages of 4 and 19 who started taking various brand-name antipsychotic drugs for the first time between 2001 and 2007. They found weight gains varied by drug but appeared to be widespread across the entire class of medications, called atypical antipsychotic drugs.

"Weight gain was pervasive even in medications usually considered to be weight neutral in adults," says Albert Einstein College of Medicine psychiatrist Christoph Correll, who led the study, which was conducted at the Zucker Hillside Hospital in Queens, N.Y. "The worry is that weight gain sustained over long periods of time can cause adverse outcomes like diabetes and heart attacks and strokes."

Children who were prescribed Zyprexa from Eli Lilly packed on 19 pounds in three months after starting the drug. Seroquel from AstraZeneca, Risperdal from Johnson & Johnson and Abilify from Bristol-Myers Squibb were not that much better, causing kids to gain 10 to 13 pounds in the same period. Seroquel and Zyprexa caused statistically significant increases in cholesterol levels, while these two drugs and Risperdal increased levels of fatty particles in the blood called triglycerides. The findings are being published in the Journal of the American Medical Association.

[Article continues at original source]