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.
Products: Zopiclone 3.75mg Tablets (Pl 15773/0028), Zopiclone 7.5mg Tablets (Pl 15773/0029) Ratiopharm Uk Limited and Zopiclone 3.75mg Tablets (Pl 04569/0450) Generics Uk T/A Mylan
The agency called on healthcare providers to advise patients about the suicide risks associated with the products.
HCPs were advised to check Marketing Authorisation Holder name while dispensing product; if any of the products listed above are being dispensed, ensure that patients are aware of the missing information by providing guidance in relation to the risk identified.
Copy of alert: https://www.cas.mhra.gov.uk/ViewAndAcknowledgment/viewAlert.aspx?AlertID=103094
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