The French National Agency for the Safety of Medicines (ANSM) acknowledged on Monday that it lacked visibility on a resumption of supplies of quetiapine, a psychiatric treatment whose shortages now affect "60% of the French market."
In this context, the ANSM has updated its recommendations to limit the impact of the shortage of this antipsychotic used in bipolar disorders and schizophrenia.
"We are facing a real lack of visibility," and "great uncertainties" regarding the availability of this treatment that will meet patients' needs, Pierre-Olivier Farenq, director of Casar, the ANSM's support center for high-risk situations, told AFP.
"Today, almost 60% of the French market is impacted" by these strong tensions which affect between "200,000 and 250,000 patients per year following long-term quetiapine-based treatment," he added.
Quetiapine is marketed under the name Xeroquel by the French laboratory Cheplapharm, as well as in generic versions by other companies. But the base molecule is largely produced by a Greek company, Pharmaten, which has been shut down since "a quality defect" emerged in the summer.
Of the 12 laboratories that market quetiapine in France, seven depend on the Greek manufacturer and are therefore "unable to resupply the market," Mr. Farenq said.
The information transmitted by manufacturers to the ANSM "would tend to indicate that the situation should improve" but, according to the official, it should be taken "with great caution."
The ANSM recalls that it initially received "rather reassuring" information from the industry before having, in December, "real concerns" regarding supplies.
At the end of January, it announced a first series of measures, including a ban on exports and, above all, a restriction on prescriptions.
In February, it introduced a system for dispensing tablets and magistral preparations prepared in pharmacies, as has already happened for certain antibiotics.
The action of magistral preparations is "increasing in power" with the objective of meeting "ideally" around "a quarter of needs", according to the ANSM, which on Monday extended the system to the 50 mg dosage in the face of "a concentration of difficulties on this dosage", in addition to the 100 mg and 150 mg dosages.
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