The ANSM takes stock of the use and safety of methylphenidate in France. If no new risk has been detected, several uses pose problems.
In France, it is not yet a scourge like in the United States. But the abuses exist and are taking hold. Ritalin is the subject of a new inventory of usage and safety data, published by the National Agency for the Safety of Medicines and Health Products (ANSM).
Methylphenidate (Ritaline, Ritalin LP, Concerta LP, Quasym LP, Medikinet) is a psychostimulant indicated in attention deficit hyperactivity disorder (ADHD) in children from the age of six, “when the measures corrective psychological, educational, social and family alone are insufficient,” the agency said.
Off-label in adults
The figures show an increase in sales. However, according to the ANSM, the use of the drug remains restricted in France, if we compare it to other European countries, can we read. The new data collected by the agency did not identify any new risk, but vigilance is still required.
Indeed, problematic use has been observed. If most of the time, the prescriptions of the drug correspond to the indication (ie, before the age of 17), an off-label use (marketing authorization) has been identified. Thus, the ANSM observed “the persistence of a limited number of treatment initiations in adult patients with ADHD”.
The agency recalls that off-label use can promote the occurrence of serious adverse effects. “Indeed, adults are at greater risk of adverse cardiovascular and cerebrovascular effects due to comorbidities and the more frequent use of associated treatments than in children”. Thus, the agency observes that many adverse effects reported by pharmacovigilance centers concern adults.
30% of initiations by liberals
Furthermore, the report also highlights that approximately 30% of treatment initiations (primo-prescription) are carried out by independent doctors, both specialists and generalists. However, the first prescription of methylphenidate is supposed to be carried out by a specialist in the hospital. In fact, the conditions of prescription and delivery have been restricted for this drug in order to avoid abuse. Obviously, the message got across badly.
“This practice has already been reported in the previous report published in July 2013, even though the specific conditions for prescribing and dispensing this narcotic were reminded to health professionals in September 2012”, emphasizes the ANSM.
In France, methylphenidate is subject to a risk management plan including national pharmacovigilance and addictovigilance monitoring. The ANSM carries out a regular analysis of the data on use and safety, because of the side effects of this drug and the risk of misuse, observed in other European countries and in the United States.
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