Other safety alerts
|
| |
| The United Kingdom: Isotretinoin: an expert review of suspected psychiatric and sexual side effects |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that it is currently reviewing the safety of isotretinoin.
Isotretinoin can cause side effects in some people, and in some cases these can be severe. Details about the possible side effects including psychiatric (mental health) and sexual effects are provided in the leaflet with the medicine. The safety of isotretinoin has been closely monitored throughout its lifecycle, with information for prescribers and patients being updated as significant new data has become available. There are ongoing patient concerns about the safety of isotretinoin. In particular, whether in some cases, the suspected psychiatric and sexual side effects continue after isotretinoin has been stopped. The Commission on Human Medicines has established an independent review of the available evidence by the Isotretinoin Expert Working Group (IEWG). Following completion of the review, a report of the IEWG’s conclusions and recommendations will be published. It is anticipated that the final report will be published in 2021.
MHRA is inviting interested individuals including patients, patient representatives, healthcare professionals, researchers, and organisations to provide their views.
Please refer to the following website in MHRA for details:
http://www.gov.uk/guidance/isotretinoin-an-expert-review-of-suspected-psychiatric-and-sexual-side-effects
In Hong Kong, there are 11 registered pharmaceutical products containing isotretinoin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to isotretinoin, but these cases are not related to psychiatric and sexual side effects.
Related news was previously issued by MHRA, and was posted on the Drug Office website on 27 Oct 2017 and 27 Aug 2020. Letters to inform local healthcare professionals were issued by the DH on 27 Oct 2017.
Currently, it is a requirement that package insert of local isotretinoin-containing products should include warnings about suicide and suicidal attempts. The package insert should also include safety information on sexual dysfunction including erectile dysfunction and decreased libido.
The DH will remain vigilant on safety update of the drug issued by MHRA and other overseas drug regulatory authorities.
Ends/Wednesday, Nov 11, 2020
Issued at HKT 16:00
|
| |
|
