first instructions and Ansm action plan

Recommendations to ensure the continuity of current treatments. Mikhail Seleznev / iStock / Getty Images Plus / via Getty Images
Résumé
In psychiatry, the specialties market in Quetiapine compressed with prolonged liberation (Xeroquel LP and generics) has been under tension for several months. All references are concerned.
The first measures taken by the ANSM to avoid a total rupture are:
- the quota of distribution in city pharmacy;
- stopping treatment initiations, except
- The use of other available drug solutions: ANSM has listed them indication by indication, by removing the molecules subject to supply difficulties.
ANSM and laboratories study other tracks to allow continuity of treatments already underway:
- Importing quetiapine specialties of prolonged liberation or immediate release (galenic form not available in France);
- The use of masterful preparations in Quétiapine
En Response to the supply tensions which are subject to the specialties of Quetiapine Tablet for prolonged Liberation (LP – cf. Framed), the National Agency for the Safety of Medicines and Health Products (ANSM) issues the first instructions for prescribers [1].
In parallel, she studies several avenues to allow continuity of current treatments.
Quetiapine is an atypical antipsychotic. It is the active ingredient of Xeroquel specialties 50 mg, 300 mg and 400 mg LP tablet and their generics.
The therapeutic indications for marketing authorization (AMM) are:
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Voltage for an indefinite period
The supply tension situation that affects the Quétiapine specialties market has been going on for several months (cf. Our article of 1is October 2024) [2]. All specialties, Xeroquel LP and its generics, are concerned.
These tensions are consecutive to a production problem encountered by the manufacturer Pharmmathen International, which produces quetiapine for several laboratories.
“Upon declaration by the laboratories concerned of the difficulties of supply, we have implemented distribution measures capped of these drugs to avoid a breakup”explains the ANSM.
Distribution is subject to quantitative quota in town (pharmacies). Hospitals and overseas departments and regions (DROM) are not impacted by this contingation.
On January 30, 2025, no discount date is announced.
No longer initiate treatment with quetiapine, with some exceptions
In this context, the ANSM asks the prescribers to no longer initiate No treatment with Quétiapine, except For patients with a depressed episode characterized as part of a bipolar disorder.
In other indications, prescribers must favor other drugs. ANSM presents them by indication:
- Treatment of schizophrenia:
- Treatment of moderate to severe manic episodes in bipolar disorders:
- Prevention of recurrences of manic or depressive episodes in patients with bipolar disorder, having already responded to treatment with quetiapine (Quétiapine is not refundable in this indication):
- in prevention of manic episodes
- in prevention of depressive episodes
- in prevention of manic episodes
- Adjuvant treatment of major depressive episodes in patients with a major depressive disorder (TDM) and who responded insufficiently to an antidepressant in monotherapy (Quétiapine is not refundable in this indication):
The ANSM dismisses risperidone, paligeridone, friendly and valproate derivatives (sodium divalproate and valpride), due to supply tensions they are currently subject to. They should not be prescribed to replace Quetiapine.
Magistral import or preparations: tracks under study
To alleviate the consequences of these tensions, the ANSM studies two tracks:
- Provision of imported specialties: the agency asked the laboratories concerned to identify which medications based on immediate liberation (LI) or prolonged liberation (LP) could be imported, regardless of the dosage. Quétiapine in the form of is not marketed in France;
- Using the masterful preparations of Quétiapine Li.
In addition, the ANSM indicates that it has called on the