Medicines for hair loss must be reviewed by the European Medicines Agency EMA, as they are suspected of causing side effects such as suicidal thoughts and self-harming behaviour.
– You want to look more closely at possible connections, says Ulla Wändel Liminga who is scientific leader at the Medical Products Agency.
One of the substances in question, finasteride, is approved for two areas of use, partly to treat milder forms of male pattern baldness and partly to treat enlarged prostate. The other, dutasteride, is approved for the treatment of enlarged prostate.
It has long been known that these substances can cause moodiness, depression and other psychiatric conditions, but now France has raised a warning flag and wants to review the connection between the substances and the side effect of suicidal thoughts.
– A recent investigation has found somewhat stronger support that suicidal thoughts could be a side effect, so an update of the product information was therefore made. It then led to France wanting a major investigation to be carried out to determine how it should be handled in the best way, says Ulla Wändel Liminga.
Want to assess the benefit-risk balance
From the side of France, it is believed that it can be established that suicidal thoughts can be a side effect, therefore they want to carry out a larger review.
– You want to assess what it means for the benefit-risk balance, that is, how great is the benefit of the treatment of hair loss related to that type of side effects, explains Ulla.
But at the same time, she says, people have known about that side effect for a long time. It is also not certain that it is caused by the treatment itself.
– There is not very strong evidence for it, but it has still been judged to be sufficient for one to want to look more closely at a connection.
May lead to drug withdrawal
What awaits now is that the connection is carefully investigated by the EMA. One has, among other things, to formulate a number of questions to the companies that are responsible for the medicines. The companies must then come back to EMA with answers.
The EMA will also review reports of suspected side effects and make a summary. When all questions have finally been answered, EMA will make recommendations.
– It can then lead to no action at all, to minor updates to the product information, to changing how the medicine may be used, or to it being withdrawn completely, says Ulla Wändel Liminga.