Oct 4 (Reuters) - The European drugs regulator said on
Friday it was reviewing anti hair-loss drugs, including
Organon's Propecia and its generic versions, over the
risks of suicidal thoughts.
The European Medicines Agency said it would recommend
whether the marketing authorisations for the drugs should be
withdrawn, suspended or maintained across the region following
its review.
Oral anti-baldness drugs called finasteride and dutasteride
have a known risk of psychiatric side effects. Finasteride,
branded as Propecia, already comes with warnings about the risk
of suicidal thoughts.
A patient advocacy group, the Post-Finasteride Syndrome
Foundation, petitioned the FDA in 2017 to order Merck ( MRK ) to either
stop selling the drug or add far stronger warnings, citing
several scientific studies.
Several years later in 2022, the U.S. Food and Drug
Administration rejected a request to remove Propecia from the
market, and ordered a warning about suicidal thoughts and
behavior on the drug's label.
Anti-baldness drugs are sold under the brand name
Propecia, from Organon, and Avodart by British drugmaker GSK
, but also have generic versions available in the market.
Organon, which was spun-off from Merck ( MRK ) in 2021,
and GSK did not immediately respond to a Reuters request for
comment.