Last week the US Food and Drug Administration (FDA) issued a warning about dangers associated with aripiprazole, an antipsychotic drug that goes by the names Abilify and Aristada.
The warning indicates that the drugs produce impulse-control problems like excessive gambling, eating, shopping, or sex. Although the FDA says these Abilify side effects are rare, they urge caution when taking the drug.
Abilify Can Create or Increase Compulsive Behaviors
Abilify’s label already comes with a warning that “pathological gambling” can be a side effect, but the FDA is now saying that additional warnings should be added to all product information for Abilify. Impulse control issues can manifest in different ways:
- Uncontrollable urges to have sex
- Binge eating or compulsive eating
- Excessive impulse shopping
These Abilify side effects can manifest in anyone who takes the drug and potentially cause harm to the patient or others. However, patients who have a family or personal history of certain disorders may be at higher risk. These disorders include:
- Obsessive-compulsive disorder (OCD)
- Bipolar disorder
- Impulsive personality
- Alcoholism, drug addiction, or other addictive behaviors
If patients or caregivers notice these signs of impulse control loss, whether newly-acquired or increased, they should contact a healthcare provider immediately. It can be dangerous to quit drugs like Abilify abruptly (or “cold turkey”) so a doctor’s advice is necessary.
Abilify Makes Billions in the US Yearly
Abilify is one of the largest selling prescription drugs in the US. In 2014, its manufacturer, Otsuka Group from Japan, listed sales at $9.3 billion, up from $7.9 billion in 2013. In 2015, 1.6 million people in the US alone were given prescriptions for aripiprazole.
Otsuka’s patent for Abilify is due to expire in 2017. Otsuka also manufactures the Nature Made brand of vitamins and supplements.
Used to Treat Hallucinations, Mood, and Autism
The added warning about Abilify side effects comes on the heels of an October 2015 announcement by the FDA that an injectable form of Abilify had been approved to treat schizophrenia.
Abilify was originally approved by the FDA for treating schizophrenia in 2002 and then in 2014 for treating some forms of bipolar disorder. Today it’s used to treat a wide array of mental disorders, including Tourette’s and autism.
New Warning Label Demanded
Even prior to last week’s FDA warning, Abilify carries a rather intimidating warning list, including special FDA “Boxed Warnings” for:
- Increased mortality in elderly dementia patients
- Increased suicide risk for children, adolescents, and young adults
- Less severe warnings such as weight gain, diabetes mellitus, low blood pressure, seizures, and cognitive impairment
The current patient information on Abilify also carries a warning about the possibility of adult suicide, but frames it as a risk already “inherent in schizophrenia and bipolar disorder.”
Drugmaker Otsuka’s Fraught Past with the FDA
The new warning requirement isn’t the first boxing match that Otsuka has had with the FDA over Abilify. Last May, Otsuka sued the FDA for allowing similar drugs from other manufacturers to enter the market by broadening the use of Abilify for Tourette’s to include adults as well as children.
Then, in October last year, Otsuka filed another complaint against the FDA claiming that by approving Aristada, another form of the drug,, the agency had violated the promised 3-year market monopoly for Otsuka’s new drug, Abilify Maintena. The FDA denied Otsuka’s request. Otsuka, however, claimed that the FDA was guilty of using “regulatory sleight of hand.”
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