The EMA will review drugs containing the two ingredients for possible links to suicidal behaviour.

The European Medicines Agency (EMA) has announced it will launch a review of medicines containing finasteride and dutasteride after concerns were raised about episodes of suicidal ideation and behavior in patients.

Medicines containing finasteride and dutasteride taken orally have a known risk of psychiatric side effects, including depression. Recently, suicidal ideation was also added as a possible side effect of unknown frequency to the product information for Propecia and Proscar, the first two finasteride-containing medications approved in several European Union (EU) countries.

To minimize risks, measures have already been taken for medications containing finasteride, including warnings in the product information for health care providers to monitor patients for psychiatric symptoms, discontinue treatment if symptoms occur, and advising patients to seek medical attention if you have psychiatric symptoms occur.

In the case of finasteride, tablets containing 1 mg of finasteride solution applied to the skin will be studied, used to treat the early stages of androgenetic alopecia (hair loss due to male hormones) in men aged 18 years at the age of 41 years. Additionally, tablets containing 5 mg of finasteride and capsules containing 0.5 mg of dutasteride are used to treat men with benign prostatic hyperplasia (BPH), a condition in which the prostate becomes enlarged and can cause problems with urine output. More information can be found in the EMA’s public health advisory.