A new safety warning has been issued by Food and Drug Administration (FDA) on Tuesday, May 03, 2016, regarding the anti-psychotic drug, Aripiprazole. The drug causes an unsurpassable urge to shop, gamble, binge-eat and have sex. Its use should be judicious, says the FDA report.
In its latest report, the FDA has warned the consumers and the prescribers about the impulse related problems associated with the administration of aripiprazole. Impulse Control problems include the unstoppable desire of a patient to be indulged in binge eating, shopping, gambling and having sexual activities. These problems have been observed in the patients who were on aripiprazole therapy, the symptoms of whom were over as soon as the therapy was stopped. These symptoms are unhealthy, and, if persist, can seriously hamper the patient’s mental faculties.
Aripiprazole is an antipsychotic drug used for the treatment of mental disorders.
What Are Impulse Control Disorders?
Impulse control disorders are characterized by the development of uncontrollable urges in the patient’s behavior like gambling, eating, going on a shopping spree and having sex.
The pathological gambling is a behavioral disorder in which irresistible impulses to gamble are generated in the patients. It is a reported adverse effect of aripiprazole, and can be found on the current drug labels of Aripiprazole. However, there is no information available on the drug labels and guides regarding other impulse control disorders. The other impulse control disorders that are currently observed in the patients taking aripiprazole are binge eating (irregular episodes of uncontrolled eating), compulsive buying disorder (urge for excessive buying and ultimately leading to distress) and hypersexual disorders (i.e., uncontrollable urge to have more sex). As a result of these problems, the patient may suffer serious healthcare and physiological complications.
On What Basis Has FDA Issued This Warning?
This warning has been issued on the basis of a database survey conducted through FDA Adverse Events Reporting System (FAES). Literature from the last 13 years, since the approval of first aripiprazole drug in 2002, was analyzed. Almost 184 cases related to impulse control disorders were observed in the US. 167 of the total cases including adults and the children were taken from FAES database and 17 from reported medical literature. An urge of pathological gambling was observed in 164 cases from FDA.
Similarly, other disorders of compulsive behavior like excessive eating, spending, sexual activity disorders and multiple-compulsive complications were also observed in three, four, nine, and four cases respectively. This survey only included those reports that were on the FDA drugs database, otherwise almost 1.6 million patients in the US were prescribed with this drug aripiprazole in 2015.
In all the cases, it was observed that there was development of irresistible or uncontrollable urges of the compulsive disorders. What was interesting is that none of the patients taking aripiprazole had a reported history of such disorders. It was therefore both safe and logical to assume that it was the drug imparting those characteristics in the subjects. What’s more convincing is that as soon as the drug therapy was stopped, the symptoms of compulsive urges either subsided or ended altogether.
This drug is classified as an atypical antipsychotic agent. It exhibits its therapeutic effects by exerting partial agonistic activity at dopaminergic (D-2) and serotonin (5-HT1A) receptors. The drug was approved by US FDA in 2002 for its use in the treatment of bipolar disorders, mania, schizophrenia, autistic disorder and Tourette’s disorder. It can also be used alone or in combination as a mood stabilizer and anti-depressant.
Schizophrenia is a mental disorder in which the usual thinking of the patient is disturbed and he subsequently loses interest in life. Autistic disorder is a condition in which the patient fails to communicate with others properly. This disorder is more frequently observed in the children. Another condition called Tourette’s syndrome arises when the patient is presented with tics – a condition that is characterized by repeated actions, movements and communications.
Aripiprazole comes under a number of trade names i.e., Abilify, Abilify Maintena, and Aristada. The first two are manufactured by Otsuka America Pharmaceuticals. Inc whereas the last is manufactured by Alkermes Pharmaceuticals.
The common side effects of this drug include gain in weight, dizziness, visual disturbances, constipation and sleeping problems.
Recommendations For Patients And Healthcare Providers
It is advised to the patients that while taking aripiprazole they must keep an eye on their behavior and mood changes. If they note any signs of the development of uncontrollable urges they should inform their prescriber immediately. They should stop taking medication after consulting with their physician only.
Similarly, the healthcare professionals are advised to inform their patients about all the potential impulse-control related complications that they may encounter while taking this drug. They should tell their patients to be aware of the development of any sort of uncontrollable urges. The physicians and other healthcare professionals should monitor the therapy with aripiprazole closely. They should also keep an eye on the family history of the patient, particularly impulse control and other psychological disorders like bipolar disorders, excessive alcoholism, drug abuse and misuse and addictive behaviors. If a patient reports any of these problems, healthcare providers can either reduce the dose of aripiprazole or stop its use and go for other alternatives.
The providers are also encouraged to report any kind of adverse events as per FDA regulations.