The medicine will remain on the shelves but will come with additional warnings about the side effects, which appear to be rare.
ADVERTISEMENT
A medication to treat men’s hair loss comes with a rare risk of suicidal thoughts, the European Union’s drugs regulator has determined.
The safety committee of the European Medicines Agency (EMA) said it reviewed 313 reports of suicidal ideation among people taking the drug finasteride, which can stimulate hair growth and prevent hair loss for men aged 18 to 41.
Finasteride is sold in 1 mg tablets under brand names such as Propecia. Meanwhile, 5 mg tablets are used to treat prostate enlargement that can cause problems urinating.
Most of the reports of suicidal thoughts came from people taking the 1 mg tablets, but “the frequency of the side effect is unknown,” the EMA concluded.
Finasteride – which already comes with warnings about mood changes, such as depression and suicidal ideation – will remain on the shelves because the safety committee concluded that its benefits outweigh its risks.
But the 1 mg tablets will now come with a card that reminds people of the risks and advises them on how to handle side effects, which can also include decreased sex drive or erectile dysfunction, the EMA said.
Seek medical advice
The agency said people who experience mood changes while taking finasteride 1 mg should stop taking it and seek medical advice.
The warnings will also be added to the medicine dutasteride, which is another treatment for prostate enlargement.
The EMA safety committee did not have evidence linking the drug to suicidal thoughts, but because dutasteride works the same way as finasteride, the information will be added as a precaution.
The agency noted that there were only a few hundred reports of suicidal ideation among about 270 million patients taking finasteride and 82 million taking dutasteride.