MHRA alert: missing information on Dr Reddy’s finasteride information leaflet

According to the MHRA, the finasteride 5mg tablets produced by Dr Reddy’s do not contain certain warnings and precautions in the patient information leaflets.

Man with patient information leaflet

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the finasteride 5mg tablets PL 08553/0261 (EL (20)A/03) produced by Dr Reddy’s Laboratories are missing special warnings and precautions in the patient information leaflets.

The effects of the medicine include mood alterations including depressed mood, depression and occasionally suicidal ideation, which were identified following a post-marketing experience, documented in the Summary of Product Characteristics (SmPC).  

However, these effects were not listed on the finasteride leaflet, prompting the MHRA to issue the class 4 medicines defect information alert.

Healthcare professionals have been advised to check the Marketing Authorisation Holder (MAH) and batch number of the drugs before dispensing to patients as well as ensuring that patients are aware of any missing information.

The MHRA has advised patients taking finasteride to be monitored for psychiatric symptoms and to seek medical assistance if these occur.

The drug is intended for the treatment of hair loss in men.