The recalls of the batches of the two sleeping pills Noctran and Mepronizine will be effective on October 27 and January 10, respectively.
The withdrawal of marketing authorizations for the two specialties concerned have not yet taken effect. However, Afssaps asks doctors to organize patient care for “prevent or limit a rebound effect or withdrawal syndrome“when treatment is stopped.
Patients treated with Noctran and Mepronizine are advised to consult their doctor in order to gradually stop their treatment. The weaning period can thus extend from a few weeks to several months, depending on each patient.
The Afssaps specifies that the gradual stopping of the treatment will necessarily require the prescription of a hypnotic treatment.
The French health agency has decided to withdraw the two medical specialties from the market due to an unfavorable benefit / risk ratio. The combination of the three active substances of the two drugs exposed the patients to a cumulative risk of adverse effects.