Finasteride

Androgenic alopecia is a hair loss condition that primarily affects the top and front of the scalp. Credit: PippiLongstocking via Shutterstock. The European Medicines Agency (EMA) has started a review of popular anti-baldness and enlarged prostate medicines finasteride and dutasteride over concerns about their possible impact on causing suicidal thoughts. Finasteride is marketed as Propecia for male pattern hair loss (androgenetic alopecia) and Proscar for treating benign prostatic hyperplasia (BPH), by MSD’s spin-off company Organon. BPH is a condition in which the prostate is enlarged causing problems with the flow of urine. Dutasteride, which is marketed by GSK as Avodart, has a similar mechanism of action and is used to treat BPH. Avodart is also sometimes used off label for hair loss, with generic versions of finasteride and dutasteride available in the market. The safety review was requested by the French regulatory agency, the National Agency for the Safety of Medicines and Health Products, which said that all available data on suicidal ideation and suicide related to finasteride and dutasteride-containing products as well as the impact of these possible risks on the benefit-risk balance of these products should be reviewed. Finasteride and dutasteride are linked to psychiatric side effects according to French regulators. Suicidal ideation was recently added to the patient information sheets and packaging for both Propecia and Proscar in the EU. However, French authorities argue that the new safety reports alter the risk profile of finasteride. This was highlighted in the 4 October Article-31 referral document: “Even though a causal association between finasteride and suicidal ideation has not been established, it was considered at least a reasonable possibility, given that known ADRs [adverse drug reactions] such as sexual dysfunction/impotence, depression, decreased libido, may lead to suicidal ideation.” See Also: WuXi debates sale of pharma operations as BIOSECURE Act advances Ascendis Pharma submits sBLA for growth hormone deficiency therapy This is not the first time that questions have been raised about the psychiatric symptoms of these drugs. In June 2022, the US Food and Drug Administration (FDA) ordered a warning about suicidal thoughts and behaviour on the drug’s label but rejected a request to remove Propecia from the market. This followed a 2017 petition from a patient advocacy group called the Post-Finasteride Syndrome Foundation, which ordered MSD to either stop selling the drug or require stronger warnings. In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) introduced a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects. Androgenetic alopecia or pattern balding is the main cause of hair loss in men but affects both men and women. According to GlobalData , there are 49 drugs in development for the condition. GlobalData is the parent company of Pharmaceutical Technology.

The European Medicines Agency is looking more closely at medicines used to treat hair loss and a condition caused by an enlarged prostate over concerns about suicidal thoughts. The review encompasses finasteride and dutasteride. Finasteride is the main ingredient in Organon’s hair loss product Propecia, and also its product for benign prostatic hyperplasia, Proscar. The safety review was requested by the French medicines agency, which concluded that while there is no established link between the drug and suicidal ideation, new safety assessments suggest it is “at least a reasonable possibility.” Dutasteride, also under review by the EMA , has a similar mechanism of action. Products containing the medicine include GSK’s Avodart, which is approved in the US for benign prostatic hyperplasia, but is sometimes used off-label to treat hair loss. Psychiatric side effects are a known risk of finasteride and dutasteride, according to European regulators. Suicidal ideation was recently added to the product information for both Propecia and Proscar in the EU. But despite warnings in the product information, French regulators argued that new safety reports may “seriously alter the risk profile of finasteride.” They noted that hair loss is “not a serious condition,” and the medicines are typically given to healthy men. Organon stood behind the safety of its finasteride products on Friday. The company said in a statement to Endpoints News that it will “work closely with the EMA to support this process.” “Regulatory agencies around the world thoroughly reviewed the safety and efficacy data for these medicines before their approval, and, together with the company, they have continued to review additional safety and efficacy data in the decades that these products have been on the market as part of routine post-marketing surveillance process,” Organon said. GSK didn’t respond to a request for comment as of press time. The EMA is expected to recommend whether the marketing authorizations for finasteride and dutasteride should stay the same, change, or be withdrawn. The FDA in 2o22 declined a petition to pull Propecia from the market, noting that the request “does not provide reasonable evidence to support a causal association between finasteride and depression.” However, the agency did require a label update adding suicidal ideation and behavior to the drug’s list of possible side effects. The agency didn’t respond Friday to questions about whether it will open a similar review of finasteride and dutasteride.