ADR that result in revision of patient information
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| The United States: Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems |
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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.
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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm498823.htm
In Hong Kong, there are 12 registered pharmaceutical products containing aripiprazole under the brand names of Abilify (6 oral and 1 injectable products), Abilify Maintena (2 injectable products) and Aripiprazole Sandoz (3 oral products). The former 9 products are registered by Otsuka Pharmaceutical (HK) Ltd, while the latter 3 products are registered by Novartis Pharmaceuticals (HK) Limited. All products are prescription-only medicines. Related news was previously issued by the Health Canada, and was posted on the Drug Office website on 3 November 2015. Letters to inform local healthcare professionals were issued on the same day. So far, the Department of Health has not received any adverse drug reaction case related to aripiprazole, as previously reported, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, May 04, 2016
Issued at HKT 15:00
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