European Medicines Agency (EMA) started reviewing assess the risk of suicidal thoughts and behavior associated with the use of drugs containing finasteride and dutasteride, present in the treatment of androgenetic alopecia in men and benign prostatic hyperplasia.
The Amsterdam-based European agency explained this Friday that its safety committee (PRAC) evaluates existing evidence linking “suicidal ideation and behavior” to drugs which contain finasteride and dutasteridetreatments available on the European market, and the actual impact of these symptoms compared to the benefit-risk ratio of the drug.
“Medicines containing finasteride and dutasteride administered orally have a known risk of psychiatric side effects, including depression. Recently, suicidal ideation was added to the product information for Propecia and Proscar as a possible side effect of unknown frequency. the first two drugs containing finasteride are approved in a number of countries European Union“, explained the EMA.
Tablets containing 1 mg of finasteride and finasteride solution applied to the skin are used to treat early stages of androgenetic alopecia (hair loss due to male hormones) in men from 18 to 41 years old.
In this case, preparations with 5 mg of finasteride and capsules containing 0.5 mg of dutasteride are used. for the treatment of men with benign prostatic hyperplasia (BPH), a condition in which the prostate is enlarged and can cause problems with the flow of urine.
Minimize risks
To minimize risks, patients are already advised Be aware of psychiatric symptoms and seek medical help if you experience any symptoms.although health care providers are asked to monitor patients receiving these substances for signs of depression and to immediately discontinue treatment if symptoms occur.
Pharmacological safety experts will now review the available data on this side effect and the EMA will make recommendations on whether European marketing authorizations for these drugs should be maintained, withdrawn, suspended or otherwise changed.