Leadership Counsel Named in Abilify Mass Tort Litigation

abilifyUS District Judge M. Casey Rodgers appointed plaintiff and defense leadership committees in the new MDL 2734, In re: Abilify Products Liability Litigation, Case No. 3:16-md-2734, in the Northern District of Florida.

He also set a science day on Feb. 23, 2017, when the parties make presentations explaining the science behind litigation. He invited New Jersey Superior Court Judge James DeLuca to attend. DeLuca is presiding over NJ state Abilify litigation.

To date there are 48 actions filed in the federal MDL against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc. Plaintiffs allege that Abilify, an atypical anti-psychotic medication commonly prescribed to treat schizophrenia, bipolar disorder, depression, and Tourette syndrome, can cause compulsive gambling behaviors.

The lawsuits involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

For more information read FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

Plaintiffs’ Committee Structure

Plaintiffs’ Co-Lead Counsel:

Kristian Rasmussen
Cory Watson, P.C.
2131 Magnolia Avenue South, Ste. 200
Birmingham, AL 35205
Phone: (205) 328-2200
Email: Rasmussen@CoryWatson.com

Gary L. Wilson
Robins Kaplan LLP
800 LaSalle Avenue
Suite 2800
Minneapolis, MN 55402
Telephone: 612-349-8500
Email: GWilson@RobinsKaplan.com

Plaintiffs’ Liaison Counsel

Bryan Aylstock
Aylstock, Witkin, Kreis & Overholtz, PLLC
17 E. Main Street, Suite 200
Pensacola, FL 32502
Telephone: (850) 202-1010
Email: baylstock@awkolaw.com

Plaintiffs Executive Committee

J. Gordon Rudd, Jr.
Zimmerman Reed LLP
1100 IDS Center, 80 S. 8th Street
Minneapolis, MN 55402
Phone: (612) 341-0400
Email: gordon.rudd@zimmreed.com

Lexi J. Hazam
Lieff Cabraser Heimann &
Bernstein, LLP
275 Battery Street, 29th Floor
San Francisco, CA 94111-3339
415.956.1000lhazam@lchb.com

Troy A. Rafferty
Levin, Papantonio, Thomas, Mitchell
Rafferty & Proctor P.A.
316 S. Baylen Street, Suite 600
Pensacola, FL 32502
Phone: (850) 435-7000
Email: trafferty@levinlaw.com

Plaintiffs’ Steering Committee

Behram V. Parekh
Kirtland & Packard LLP
2041 Rosecrans Ave., Third Floor
El Segundo, CA 90245
Phone: 310-536-1000
Email: bvp@kirtlandpackard.com

Chris T. Hellums
Pittman, Dutton & Hellums, P.C.
2001 Park Place N., Ste 1100
Birmingham, AL 35203
Phone: (205) 322-8880
chrish@pittmandutton.com

George T. Williamson
99 Nesbit Street
Punta Gorda, Florida 33950
Phone (941) 639-1158
gwilliamson@farr.com

Jennifer Liakos
Napoli Shkolnik PLLC
525 South Douglas Street, Suite 260
El Segundo, CA 90245
Phone: (310) 331-8224
Email: jliakos@napolilaw.com

M. Brandon Smith, Esq.
Childers, Schlueter & Smith L.L.C.
1932 North Druid Hills Road, Suite 100
Atlanta, GA 30319
Phone (404) 419-9500
bsmith@cssfirm.com

Marlene J. Goldenberg
GoldenbergLaw, PLLC
800 LaSalle Avenue, Suite 2150
Minneapolis, MN 55402
Phone: (612) 333-4662
Email: mjgoldenberg@goldenberglaw.com

Shanon J. Carson
Berger & Montague, P.C.
1622 Locust Street
Philadelphia, PA 19106
Phone: 215-875-3000
Email: scarson@bm.net

Plaintiffs’ Federal/State Liaison Counsel

Munir R. Meghjee
Robins Kaplan LLP
800 LaSalle Avenue Suite 2800
Minneapolis, MN 55402
Telephone: 612-349-8500
Email: MMeghjee@RobinsKaplan.com

Plaintiffs’ Fees and Common Benefit Fund Committee

Bryan Aylstock
Aylstock, Witkin, Kreis & Overholtz, PLLC
17 E. Main Street, Suite 200
Pensacola, FL 32502
Telephone: (850) 202-1010
Email: baylstock@awkolaw.com

Chris T. Hellums
Pittman, Dutton & Hellums, P.C.
2001 Park Place N., Ste 1100
Birmingham, AL 35203
Phone: (205) 322-8880
chrish@pittmandutton.com

Defendants’ Liaison Counsel

Larry Hill
lhill@mhw-law.com
Moore, Hill & Westmoreland, P.A.
350 West Cedar Street
Maritime Place, Suite 100
Pensacola FL 32502
Telephone: (850) 434-3541

Joint Discovery Committee

Plaintiffs
Behram V. Parekh
Kirtland & Packard LLP
2041 Rosecrans Ave., Third Floor
El Segundo, CA 90245
Phone: 310-536-1000
Email: bvp@kirtlandpackard.com

George T. Williamson
99 Nesbit Street
Punta Gorda, Florida 33950
P. (941) 639-1158
gwilliamson@farr.com

Stephen H. Echsner
Aylstock, Witkin, Kreis &
Overholtz, PLLC
17 E. Main Street, Suite 200
Pensacola, FL 32502
Phone: 850-202-1010

Stephen Hunt, Jr.
Cory Watson, P.C.
2131 Magnolia Avenue South, Ste. 200
Birmingham, AL 35205
Phone: (205) 328-2200
Email: Shunt@CoryWatson.com

Bristol-Myers Squibb Company
Lauren Colton
Hogan Lovells US LLP
100 International Drive, Suite 200
Baltimore, Maryland 21202
410-659-2700
lauren.colton@hoganlovells.com

Matthew Eisenstein
Arnold & Porter LLP
601 Massachusetts Ave, NW
Washington, DC 20001
202-942-6606
matthew.eisenstein@aporter.com

Otsuka Pharmaceutical Co. Ltd. & Otsuka America Pharmaceutical Inc.
(“the Otsuka Defendants”)

Luke A. Connelly
Winston & Strawn LLP
200 Park Avenue
New York, NY 10166-4193
T: 212-294-6882
LConnell@winston.com

Matthew A. Campbell
Winston & Strawn LLP
1700 K St. NW
Washington, DC 20006-3817
T: 202-282-5848
MACampbe@winston.com

Joint Settlement Committee

By January 30, 2017, the Joint Settlement Committee must propose a settlement master or inform the Court if they are unable to reach an agreement on a settlement master, in which case, each side (Plaintiffs and Defendants) should propose a settlement master.

Plaintiffs

Ernest Cory
Cory Watson, P.C.
2131 Magnolia Avenue S., Ste. 200
Birmingham, AL 35205
Phone: (205) 328-2200
Email: ECory@CoryWatson.com

Tara D. Sutton
Robins Kaplan LLP
800 LaSalle Avenue
Suite 2800
Minneapolis, MN 55402
Telephone: 612-349-8500
Email: TSutton@RobinsKaplan.com

Bristol-Myers Squibb Company

Anand Agneshwar
Arnold & Porter LLP
399 Park Avenue
New York, NY 10022
212-715-1107
anand.agneshwar@aporter.com

The Otsuka Defendants
Matthew A. Campbell
Winston & Strawn LLP
1700 K St. NW
Washington, DC 20006-3817
T: 202-282-5848
MACampbe@winston.com

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$19.5 Million Settlement with Bristol-Meyers Squibb for Illegally Marketing Abilify

abilify-2California Attorney General Kamala D. Harris today announced that California, along with 42 other states and the District of Columbia, has reached a $19.5 million agreement with Bristol-Myers Squibb over allegations that the company illegally marketed the popular atypical antipsychotic drug Abilify.

In 2009, California and other states launched a multistate consumer protection investigation of Otsuka America Pharmaceutical, Inc., which manufactures Abilify, and Bristol-Myers Squibb, which is largely responsible for promoting Abilify.

The investigation found that Bristol-Myers Squibb engaged in off-label marketing by illegally promoting Abilify for therapeutic uses for which it was not approved, such as certain pediatric uses and to treat dementia. In addition to incentivizing sales representatives to engage in off-label marketing, the investigation found that the company misled doctors and patients about the drug’s risks and side effects and misrepresented the findings of scientific studies concerning the drug in marketing messages.

“These companies endangered and compromised the health and well-being of millions of Americans in order to turn a profit,” said Attorney General Harris. “This settlement makes clear that pharmaceutical companies using deceptive and unlawful tactics to promote drugs will not be tolerated in the United States.”

MDL created in October

Some 43 federal lawsuits against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc. are consolidated in MDL 2734, In re: Abilify Products Liability Litigation, created in October 2016 and supervised by US District Judge M. Casey Rodgers in the Northern District of Florida.

Plaintiffs allege that Abilify can cause compulsive gambling behaviors. All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

Abilify is approved by the Food and Drug Administration to treat schizophrenia, bipolar disorder, major depressive disorder, and Tourette’s disorder. Abilify, known as a blockbuster drug because of its popularity, generated $5.5 billion in sales in 2014, with Bristol-Myers Squibb receiving approximately $2.02 billion of that amount.

The settlement places strict rules on how Bristol-Myers Squibb can promote and market Abilify going forward, including prohibiting the company from promoting the drug for off-label uses, compensating health care providers for promotional activities without disclosing their connection to the company, using medical grants to promote the drug, and making unsubstantiated safety or efficacy comparisons between Abilify and other products.

In addition, under the terms of the agreement, Bristol-Myers Squibb must provide only accurate and scientifically balanced information about Abilify, conspicuously disclose risks, and take clear steps to ensure it is not creating financial incentives for promotion, sales, and marketing that would violate the law.

 

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New MDLs Consolidate Cases for Abilify, Roundup, Talc and Taxotere

Consolidating thousands of lawsuits involving Abilify schizophrenia drug, Roundup herbicide, Talc powder and Taxotere cancer drug, US Judicial Panel on Multidistrict Litigation (JPML) in Washington, DC, created new multidistrict litigation (MDL) dockets for the mass tort cases.

This is good news for plaintiffs. In due course the assigned courts will create short-form complaints and plaintiff fact sheets, facilitating the filing of new actions. Each litigation will be led by a plaintiff’s steering committee appointed by the judge, who will set a discovery schedule and select representative cases for bellwether trials.

abilifyAbilify (Aripiprazole)

Responding to a motion from all the parties, the JPML created new MDL 2734, In re: Abilify Products Liability Litigation, supervised by US District Judge M. Casey Rodgers in the Northern District of Florida. The ruling consolidates 22 actions filed in 12 district courts against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.

Plaintiffs allege that Abilify, an atypical anti-psychotic medication commonly prescribed to treat schizophrenia, bipolar disorder, depression, and Tourette syndrome, can cause compulsive gambling behaviors. All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

For more information read FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

WHO-says-Roundup-probably-causes-cancerRoundup (Glyphosate)

Granting the plaintiffs’ motion, the JPML created the new MDL No. 2741, In Re: Roundup Products Liability Litigation, supervised by Judge US District Vince Chhabria in the Northern District of California. Monsanto opposed consolidation. There are 21 actions pending in 14 districts. Including the potential tag-along actions, there are now 37 actions pending in twenty-one districts. More than ten different law firms represent plaintiffs in these actions, which are spread across the country.

These actions share common factual questions arising out of allegations that Monsanto’s Roundup herbicide, particularly its active ingredient, glyphosate, causes non-Hodgkin’s lymphoma. Plaintiffs each allege that they or their decedents developed non-Hodgkin’s lymphoma after using Roundup over the course of several or more years. Plaintiffs also allege that the use of glyphosate in conjunction with other ingredients, in particular the surfactant polyethoxylated tallow amine (POEA), renders Roundup even more toxic than glyphosate on its own.

For more information read New Illinois Lawsuit Charges Monsanto’s Roundup Causes Cancer

talc johnson & johnsonTalcum Powder

The JPML created the new MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, supervised by US District Judge Freda L. Wolfson in the District of New Jersey. There are 10 actions in 8 districts.

The plaintiffs allege that they or their decedents developed ovarian or uterine cancer following perineal application of Johnson & Johnson’s talcum powder products (namely, Johnson’s Baby Powder and Shower to Shower body powder). Two of the actions are consumer class actions brought on behalf of putative classes of women who allege that defendants deceptively marketed the talcum powder products for feminine hygienic use without disclosing talc’s carcinogenic properties. All the actions involve factual questions relating to the risk of cancer posed by talc and talc-based body powders, whether the defendants knew or should have known of this alleged risk, and whether defendants provided adequate instructions and warnings with respect to the products.

For more information read Behind the $55 Million Talc Verdict: J&J Knew About Cancer Risks Since the 1970s

taxotere hair lossTaxotere (Docetaxel)

The JPML created new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation, supervised by Chief US District Judge Chief Judge Kurt Engelhardt in the Eastern District of Louisiana. The litigation consists of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

Plaintiffs in these actions each allege that they experienced permanent hair loss as a result of using Taxotere. All actions will require discovery regarding the design, testing, manufacturing, marketing, and labeling of Taxotere. The defendant is Sanofi-Aventis U.S. LLC.

All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.

For further information read FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

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Considerations for Plaintiff Attorneys when Starting a Successful Mass Tort Practice

John Ray
John Ray

Mass Tort Litigation has emerged as the only effective check on pharmaceutical and medical device companies that make dangerous products injuring thousands of Americans. Mass tort attorneys have filed 140,000 lawsuits in 250 federal multidistrict litigation dockets as of September 2016.

Many attorneys are expanding their personal injury practices to include mass torts because the US Judicial Panel on Multidistrict Litigation has organized the litigation so effectively against the multi-billion-dollar drug and medical device industry.

“The FDA is not a check or a balance on the pharmaceutical industry,” said Mass Tort Nexus Consultant John Ray, recently teaching a four-day course about mass torts in Fort Lauderdale, FL. “Plaintiff attorneys are the only check on the pharmaceutical industry.”

In recent years mass tort lawyers have recovered $10 billion in settlements for injured Americans: $4.8 billion for Vioxx, $1.8 billion for Yaz, $1.3 billion for the Stryker hip and $2.5 billion for the DePuy hip.

“The drug companies bake these cases into their business model,” Ray said. “Defendants call it a win when they don’t put a warning on their labels, don’t get sued and don’t have to pay a judgment at all. This means they got away with it. That happens a lot.”

When a federal MDL is created, the supervising judge will approve a standard short-form or long-form complaint, plus a plaintiffs’ fact sheet which replaces interrogatories. The consolidation of cases means that a mass tort lawyer can file a notice of appearance and file cases regardless of the jurisdiction of the plaintiff, defendant company or the location of the plaintiff’s attorney.

Criteria for a viable case

Cases that are attracting many mass tort attorneys now involve Xarelto, IVC filters and Pradaxa. Among the many factors determining the viability of a mass tort are:

  • Preemption. Congress has expressly preempted certain claims. Further, courts have ruled that generic manufacturers cannot be sued.
  • Statute of limitations: State laws govern when the statute of limitations starts to run, but in most federal litigation, the date that the FDA issues a “black box warning” for a drug marks the date when the time limit begins to run.
  • Legal viability. In many cases, research will show a connection between a drug and injuries among patients, but specific causation must be proved in a trial. Experts must be found who will survive a Daubert motion to disqualify.
  • Financial viability of the defendant. While Johnson & Johnson had $46.8 billion in annual income in 2015, some small makers of IVC filters went out of business before they could sell one.
  • Average case value. The average Pradaxa case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.
  • Plaintiff numerosity. Cases in the Syngenta Corn Market Crash Litigation involve every corn producer in America, and IVC Filters have been implanted in millions of patients over the last 40 years.
  • Cost per client acquired. Costs can add up with Facebook advertising, website marketing, and lead generation companies. For example, The Sentinal Group will advertise for clients for a fee of $100,000 to obtain 250 calls for Xarelto plaintiffs, with 1 out of 5 calls leading to a signed client.
  • Case duration. Mass torts are litigation for the long haul, with the average case lasting 5 years and 4 months before settlement, according to Ray, with 7 years being a good benchmark for the duration of a case.
  • Case value. An example of a good outcome is with Pradaxa. The average settlement is $162,000. Calculating 40% in gross contingent fees would equal $64,800. Another 7% is deducted ($4,536) for the common benefit to pay the steering committee. Of the remaining fee of $60,204, a 40% referral fee of $24,015 is deducted for the co-counsel that handled the litigation. This leaves a net fee of $36,189 for the attorney who originated the case.
  • Financial resources. Costs to fund a case can be in the tens of thousands of dollars, with costs reaching hundreds of thousands for members of the plaintiffs steering committee.
  • Personnel resources. A law firm will have to train a small army of intake specialists to answer incoming calls when advertising is running. Additional personnel will be needed to obtain and review medical records.

Perfect timing

There are three phases of mass tort litigation, and perfect timing will be needed to enter a particular case.

Emerging Phase Cases. In this early phase, the cost to acquire a client is the least expensive, but there many issues of case viability. For example, the courts are still considering motions to consolidate cases involving Abilify and Roundup. With Abilify the FDA has issued a safety warning but not a black box warning. With Roundup the EPA has not classified the herbicide as a carcinogen, but foreign governments have.

Litigation Phase Cases. It is considered an ideal time to enter into a mass tort when the JPML has created a multi-litigation docket (MDL). Some 250 MDLs include mature litigation involving Benicar, Lipitor, Viagra, Xarelto and Zofran, and many legal issues have been settled. The supervising judge will schedule bellwether or test cases for trial.

Settlement Phase Cases. This is the very safest time to enter litigation because all an attorney must do is find qualified plaintiffs. Example cases involve transvaginal mesh, Levaquin and Pradaxa. However at this late phase the cost to acquire a client is at its highest.

“Whatever you do, maintain your single-event plaintiff’s practice,” Ray advised. “You will have to keep paying the costs of a mass tort case until it settles, and you will need a huge cash supply or credit line.”

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Abilify Patients Move to Consolidate Cases to Florida Federal Court

abilifyPatients who took Abilify and suffered compulsive sex, gambling and shopping side effects have requested that the US Judicial Panel on Multidistrict Litigation consolidate 26 federal lawsuits against the manufacturers into the US District Court for the Norther District of Florida.

A decision on the motion, filed on June 24, is expected soon, because the defendants are also seeking consolidation. An MDL would  centralize 26 Abilify cases filed by four different law firms, pending in 12 different federal district courts before 14 different federal judges. The case is In Re: Abilify Compulsive Behavior Products Liability Litigation.

In addition, 13 Abilify compulsive behavior lawsuits pending in New Jersey state court have been consolidated in one proceeding for pretrial coordination. In total, Plaintiffs’ counsel anticipate that hundreds of additional Abilify compulsive behavior cases will be filed.

24 million patients

Since its U.S. launch over 13 years ago, an estimated 24 million patients have used Abilify with sales in 2013 totaling $2.3 billion. Doctors widely prescribe it to treat patients with schizophrenia, bipolar disorder, and major depressive disorder. The defendants are Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.

The movants recommend the new MDL be supervised by Judge Margaret Catharine “Casey” Rodgers in Pensacola, FL, before whom two Abilify compulsive behavior cases are pending. There are no MDLs pending in the Florida courthouse.

Denise Miley and Brad Miley of Maple Grove, Minnesota, filed the first lawsuit on January 12, 2016, in the District of Minnesota, Miley v. Bristol-Myers Squibb Company, Case 0:16-cv-00067.

Abilify was introduced in 2002 as an atypical anti-psychotic prescription medicine discovered by Defendant Otsuka Pharmaceutical Co., Ltd. In November 2012, the European Medicines Agency required that the defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling.

Warnings since 2012

Agencies began issuing warnings in 2012:

  • In November 2012, the European Medicines Agency required that the defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling.
  • In November 2015 Canadian regulators concluded that there is “a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality.”
  • On May 3, 2016, the FDA, in an “FDA Safety Communication,” announced that warnings about “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex” would be added to the Abilify label. From 2005 to 2013, an FDA report showed that Abilify accounted for at least fifty-four reports of compulsive or impulsive behavior problems, including thirty reports of compulsive gambling, twelve reports of impulsive behavior, nine reports of hypersexuality, and three reports of compulsive shopping.

Among the issues that must be decided in a case are:

  1. Whether and to what extent Abilify is a substantial factor in causing the alleged compulsive behavior.
  2. When Defendants learned of any such connection between Abilify and the alleged compulsive behavior.
  3. Whether, and for how long, Defendants concealed any such knowledge from prescribing physicians.
  4. Whether Defendants failed to provide adequate and timely warnings and instruction about the alleged relationship between Abilify and compulsive behavior.
  5. Whether Defendants engaged in fraudulent and illegal marketing practices including, but not limited to, making unsubstantiated claims about the effectiveness and superiority of Abilify.
  6. Whether Defendant Otsuka Pharmaceutical Co, Ltd. is subject to personal jurisdiction in the United States courts.

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FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

Gambling alcohol sad despairThe U.S. Food and Drug Administration is warning that uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada and generics).

These uncontrollable urges stopped when the medicine was discontinued or the dose was reduced.

Current drug labels do not entirely show the nature of the impulse-control risk. “These compulsive behaviors can affect anyone who is taking the medicine. As a result, we are adding new warnings about these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products,” the FDA says.

Minnesota case

Litigation is active against manufacturers Bristol-Myers Squibb, Otsuka Pharmaceutical Co., Ltd., and Otsuka America Pharmaceutical, Inc. In a case filed by Denise and Brad Miley in federal court in Minnesota, CASE 0:16-cv-00067, Denise Miley took Abilify and as a result developed compulsive gambling behaviors. She began taking Abilify in September 2014, began compulsively gambling shortly thereafter, and stopped gambling soon after she stopped taking the drug.

The drug companies do not warn Abilify users or prescribers in the United States about the risk of compulsive gambling or other compulsive behaviors.

Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are taking aripiprazole. “Closely monitor patients with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors,” the FDA said.

Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression. Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking. It can stabilize mood, improve depression, and decrease the tics of Tourette’s disorder.

184 reports of impulse-control problems

In the 13 years since the approval of the first aripiprazole product (Abilify) in November 2002, the FDA identified a total of 184 case reports where there was an association between aripiprazole use and impulse-control problems.

  • There were 167 U.S. cases, which included adults and children.
  • Pathological gambling was the most common (164 cases), but other compulsive behaviors including compulsive eating, spending or shopping, and sexual behaviors were also reported.

Approximately 1.6 million patients received an aripiprazole prescription from U.S. outpatient retail pharmacies during 2015.

“We strongly advise health care professionals, patients, and caregivers to report side effects involving aripiprazole (Abilify, Abilify Maintena, Aristada) and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page,” the FDA said.

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FDA Warns About Abilify Causing Compulsive Sex, Eating and Gambling

infographic-side-effects-abilify-lawyerThe 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 FDA identified. In addition, FDA has 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, FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

See the FDA Drug Safety Communication for additional information, including a Data Summary.

Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression.  Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking. It can stabilize mood, improve depression, and decrease the tics of Tourette’s disorder.

Uncontrollable Urges

Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse-control problems.  These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors.  Consider reducing the dose or stopping the medicine if such urges develop.

Patients and caregivers should be alert for uncontrollable and excessive urges and behaviors while taking aripiprazole. It is important to talk with a health care professional as soon as possible if you or a family member experiences any of these uncontrollable urges, in order to prevent or limit possible harm.  Patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional.

See the FDA Drug Safety Communication for additional information for patients, caregivers, and health care professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

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