MHRA Issues Alert that Imovane Generics Didn’t Note Risk of Suicide

The UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) has issued a warning about the labeling on generic forms of the insomnia drug zoplicone manufactured by Mylan and Ratiopharm UK that fails to disclose possible suicide risks.

MHRA noted that the Patient Information Leaflet and the Summary of Product Characteristics were supposed to warn of an increased risk of suicide in patients taking sedatives and hypnotics such as zoplicone, and that the drug should be administered with caution to patients exhibiting symptoms of depression.

The agency called on healthcare providers to advise patients about the suicide risks associated with the products.