After having published an update, the Medicines Safety Agency is setting up a monitoring of off-indication prescriptions for Abilify, indicated in schizophrenia.
The National Medicines Safety Agency (ANSM) has taken over the Abilify (aripiprazole) dossier. This antipsychotic drug, authorized in schizophrenia and bipolar disorder, is prescribed outside of the approved indications. The Agency announces that it has set up national pharmacovigilance monitoring, which consists of monitoring the occurrence of adverse effects in patients undergoing treatment.
Reduce the risks
Taking aripiprazole is associated with an increased risk of suicide in some patients. This is a documented side effect, since it is listed in the summary of product characteristics (SPC). But cases of so-called off-label prescriptions, that is to say that do not correspond to the indications, have been reported to the authorities.
The ANSM therefore asked the laboratories that produce Abilify and its generics for additional information on exposure to these off-label drugs, as well as pharmacovigilance data. It also questioned them on the measures to be taken in order to allow a prescription “in accordance with the terms of the MA for their specialty while reducing the risks associated with unjustified off-label use”.
7 suicide cases
In March, it also sent a letter reminding the precautions for use and the indications approved in France to the health professionals concerned (psychiatrists, child psychiatrists, pediatricians, general practitioners, dispensary pharmacists). Undoubtedly at the origin of this development, an open letter of the association Vaincre Autisme. She was sent after the suicide of a 13-year-old autistic child on Abilify. In his letter to the Minister of Health, Marisol Touraine, the president of the association called for an investigation into the prescription conditions of the drug in France.
Because since the start of the product’s sale in 2002, 7 cases of suicide and 137 suicidal behaviors or attempted suicides have been recorded in children or adolescents (3-17 years old). This is why, as part of such treatment, close monitoring is recommended.
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