May 8 (Reuters) - The European drugs regulator said on
Thursday its safety panel has confirmed suicidal thoughts as a
side effect of the drug finasteride and its generic versions
used as a treatment for hair loss, following an EU-wide review
of available data.
Most cases of suicidal ideation were reported in people
using 1 milligram (mg) finasteride tablets, which are used to
treat androgenetic alopecia - a condition of hair loss brought
on by male hormones.
The frequency of the side effect is unknown, meaning that it
is not possible to estimate it from available data, the health
agency added.
A patient card will be included in the packages of 1 mg
finasteride tablets to remind patients of these risks and to
advise them about the appropriate course of action, the health
regulator said.
The European Medicines Agency in October last year said
it was reviewing anti hair-loss drugs, finasteride and
dutasteride, over the risk of suicidal thoughts.
The drugs are sold under the brand name Propecia
(finasteride) by Organon, and as Avodart (dutasteride)
by British drugmaker GSK. The generic versions of these
drugs are available in the market.
The EMA, however, added that it was not possible to
establish a link between suicidal ideation and dutasteride based
on the reviewed data.
The regulator said information about the mood changes seen
with finasteride will also be added to dutasteride's product
information as a precaution.