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REXULTI WARNING LABELS

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In 2016, research from the FDA linked the popular antipsychotic Abilify to severe impulse-control disorders, including pathological gambling and shopping. Now, researchers have raised similar concerns about the successor drug Rexulti.

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If you or a loved one experienced impulse-control issues after using Rexulti, contact our experienced attorneys today to learn more.

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Litigation Status: Inactive
Accepting Clients: No
Content Author: Laurence Banville
Edited By: Emily Smith
Published: June 13, 2018
Fact checked on: June 13, 2018
"The lawyers that form this alliance truly work on these cases and often take leadership positions on the steering committees that litigate them." - Laurence Banville

Did you see a TV commercial about Rexulti lawsuits? A number of law firms have begun to produce these ads, notifying Rexulti patients and their loved ones about a pending litigation centered on the powerful atypical antipsychotic drug.

Does Rexulti Cause Impulse-Control Disorders?

Some medical researchers have begun to worry that Rexulti, much like its predecessor Abilify, may increase the risk for impulse-control disorders, including compulsive gambling and shocking. Yet unlike Abilify, the warning label for Rexulti does not warn of these potential risks.

Instead of providing a full-throated warning to the public, as many legal experts believe is warranted, Rexulti’s labeling mentions uncontrollable urges only in relation to Abilify. “Post-marketing reports of impulse-control disorders,” according to Rexulti’s warning label, “including pathological gambling and hypersexuality have been reported in patients treated with another antipsychotic with partial agonist activity at dopamine receptors.”

Obviously, the label, drafted by Rexulti’s manufacturer, Otsuka Pharmaceuticals, avoids the suggestion that Rexulti could cause impulse-control disorders. And, despite the fact that Rexulti’s label warns that “patients with a prior history of impulse-control disorder may be at increased risk and should be monitored carefully,” some observers believe that the warning label leaves the impression that Rexulti is distinguished from Abilify by an utter inability to cause uncontrollable urges.

Why Otsuka Warned Of Abilify Risks

Otsuka Pharmaceutical didn’t warn patients about the full scope of Abilify’s link to impulse-control disorders of its own accord. Before May 2016, the drug’s warning label mentioned pathological gambling as a reported side effect, but said nothing of compulsive shopping, eating or sex addiction.

That year, after receiving dozens of terrifying reports from patients who had developed compulsions and uncontrollable urges after taking Abilify, the US Food & Drug Administration was forced to take action. A new section was added to Abilify’s warning label, listing pathological gambling, compulsive eating, compulsive shopping and hypersexuality among the drug’s side effects.

Reported Cases Of Pathological Gambling, Shopping

An analysis of FDA adverse event data identified 184 cases of an impulse-control disorder in Rexulti patients between November 2002 and May 2016. 167 of these case reports came from the US, the FDA said.

“In the majority of cases,” the federal agency continued, “patients with no prior history of the compulsive behaviors experienced uncontrollable urges only after starting aripiprazole treatment. Within days to weeks of reducing the dose or discontinuing aripiprazole, these uncontrollable urges stopped.”

Challenge-Dechallenge Reactions

In their last observation, FDA reviewers pointed to a challenge-dechallenge reaction, a classic marker of a causal relationship between a drug and a side effect.

Patients who took Abilify appeared to develop impulse-control disorders, even though they never had a prior history of impulse control; their bodies were “challenged” by the drug, leading to a characteristic response, an impulse-control disorder.

When the drug was stopped (the patient’s body was “dechallenged”), the response went away; the patients were freed of their compulsive ideation and behavior. That’s precisely the pattern of reactions we would expect if Abilify causes impulse-control disorders.

Do Rexulti & Abilify Share Side Effects?

But what does all this have to do with Rexulti? It’s very simple, actually. Rexulti and Abilify are extremely similar medications.

Otsuka’s History In Antipsychotics

Both drugs are manufactured by Otsuka Pharmaceutical, a Japanese pharmaceutical giant based in Tokyo.

Abilify entered the US market in 2002, first as a treatment approved for schizophrenia in adults, and quickly became a success. Over the next 12 years, the drug’s approvals were expanded to bipolar disorder, irritability in pediatric patients with autism, major depressive disorder (as an adjunct to antidepressants) and schizophrenia in children.

Otsuka’s antipsychotic was opened to numerous patient populations; it was a valuable market. Then, the patent on Abilify’s active ingredient, aripiprazole, ran out. Generic manufacturers came up with their own versions and flooded the market with cheap equivalents, taking a deep cut out of Otsuka’s revenue.

Did Otsuka “Evergreen” Abilify?

But Otsuka had prepared for this eventuality. The company’s researchers had already designed a replacement for Abilify. It was called brexpiprazole, but we know it more commonly as Rexulti.

Aripiprazole and brexpiprazole are very similar drugs and likely have a similar mechanism of action in the human body. Some observers have even accused Otsuka of “evergreening” Abilify – making negligible changes to the drug’s active ingredient in order to secure a new patent and recapture the antipsychotic market.

Does Rexulti’s Warning Label Lack Crucial Warning?

Despite their similarities, the warning labels for Abilify and Rexulti are very different. As we’ve seen, Abilify bears prominent warnings for patients about the risk of developing an impulse-control disorder, carefully noting obsessive gambling, shopping and hypersexuality. Rexulti’s warning label only mentions that “another antipsychotic” (Abilify) can cause those disorders.

The Terrible Toll Of Impulse-Control Disorders

Having an impulse-control disorder can be a life-ruining affliction. There is, first, the unspeakable torture of obsessive thinking, of living in the grips of a thought or urge that repeats and repeats, over and over again, day in and day out. The loss of control over one’s mental life is crippling.

Then, for those patients who act on their obsessive compulsions, there can be extraordinary psychological and practical consequences.

We’ve spoken with patients who lost everything to their gambling addiction, mortgaging their homes and the future of their children to feed their uncontrollable urges. We’ve spoken to men and women who have been bankrupted by compulsive shopping. This is a terrible disease, one that could be caused by the medication that you or your loved one is taking.

Free Legal Consultations

Our experienced attorneys have opened a full investigation into cases of impulse-control disorders in Rexulti patients.

If you or a loved one developed uncontrollable urges to shop or gamble after taking this drug, contact our lawyers today to learn more about your legal options. We may be able to help. To find more information, call or complete our contact form now for a free legal consultation.

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