Other safety alerts
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| European Union: Updated measures for pregnancy prevention during retinoid use: Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids |
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The European Medicines Agency (EMA) has completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur will be included in the prescribing information for oral retinoids (those taken by mouth).
Retinoids include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin. They are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including severe acne and psoriasis. Some retinoids are also used to treat certain forms of cancer.
The review confirmed that oral retinoids can harm the unborn child and must not be used during pregnancy. In addition, the oral retinoids acitretin, alitretinoin and isotretinoin, which are used to treat conditions mainly affecting the skin, must be used in accordance with the conditions of a new pregnancy prevention programme by women able to have children. Topical retinoids (those applied to the skin) must also not be used during pregnancy, and by women planning to have a baby.
Regarding the risk of neuropsychiatric disorders, the limitations of the available data did not allow to clearly establish whether this risk was due to the use of retinoids. However, considering that patients with severe skin conditions may be more vulnerable to neuropsychiatric disorders due to the nature of the disease, the prescribing information for oral retinoids will be updated to include a warning about this possible risk. Available data suggest that topical retinoids do not carry a risk of neuropsychiatric side effects, and therefore no additional warnings need to be added to the prescribing information.
The review of retinoids was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which assessed the available data including published literature, post-marketing reports of side effects and additional information collected from stakeholder meetings and written submissions. The EMA’s Committee for Medicinal Products for Human use (CHMP) has now endorsed the PRAC recommendations and adopted the Agency’s final opinion. The CHMP opinion will be sent to the European Commission, which will take a final legally binding decision valid across the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002928.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 49 registered pharmaceutical products containing retinoids, including acitretin (2 products), adapalene (14), isotretinoin (11), tazarotene (3) and tretinoin (19). All products are prescription-only medicines. There is no registered pharmaceutical product containing alitretinoin or bexarotene. Related news was previously issued by EMA, and was posted on the Drug Office website on 9 Jul 2016 and 10 Feb 2018. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction (ADR) related to isotretinoin associated with miscarriage and ectopic pregnancy. DH has also received 3 cases of ADR related to tretinoin, but none of them was related to adverse effects in pregnancy and of neuropsychiatric disorders. DH has not received any case of ADR related to other retinoids. Letters to local healthcare professionals to draw their attention to the EMA recommendation were also issued on 12 Feb 2018. In light of the above EMA’s announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, March 24, 2018
Issued at HKT 12:30
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