Other safety alerts
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| European Union: EMA starts review of retinoid medicines |
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The European Medicines Agency (EMA) has started a review of retinoid medicines to evaluate measures currently in place for pregnancy prevention and for minimising the possible risk of neuropsychiatric disorders.
Retinoids (which include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin) are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including acne and psoriasis. Some retinoids are also used to treat certain forms of cancer.
Retinoids taken by mouth can have harmful effects on the unborn child. These medicines therefore must not be used in pregnant women, and pregnancy prevention programmes (PPPs) for retinoids have been set up across the European Union (EU). For retinoids applied to the skin, the evidence of these effects is less robust; however, it is generally recommended that these medicines should not be used during pregnancy.
Although PPPs have helped reduce the number of pregnancies in women taking retinoids by mouth, pregnancies still occur. A recent analysis of the effectiveness of the isotretinoin PPP, which considered post-marketing data and published studies, raised concerns about how well PPPs are followed in practice, and about the lack of consistency at EU level. Concerns around the measures in place for pregnancy prevention have also been raised with regard to retinoids applied to the skin.
Following a request from the United Kingdom’s medicines agency, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will review the measures currently in place for pregnancy prevention, including the warnings and recommendations in the product information for all retinoid medicines, to ensure that they are effective and appropriate.
The PRAC will also review the possible risk of neuropsychiatric disorders such as depression, anxiety, psychotic disorders and suicidal behaviour with retinoids. Warnings about this possible risk are already included in the product information for some of these medicines. The Committee will review the extent and nature of these warnings to ensure that they reflect the available evidence for retinoids taken by mouth, as well as for those applied to the skin.
While the review is ongoing, patients who have any concerns about their medication should discuss them with their healthcare professional.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../human_referral_prac_000061.jsp&mid=WC0b01ac05805c516f
In Hong Kong, there are 52 registered pharmaceutical products containing retinoids, including 2 acitretin, 15 adapalene, 12 isotretinoin, 3 tazarotene and 20 tretinoin products. All these products are prescription only medicines. There are no registered products containing alitretinoin or bexarotene. So far, DH has received 1 adverse drug reaction case related to isotretinoin associated with miscarriage during pregnancy. In Hong Kong, warnings on the teratogenic effects and pregnancy preventive measures are included in the package inserts of products containing retinoids, e.g. isotretinoin and acitretin. In view of the above EMA announcement, DH will remain vigilance on the future review results by the EMA.
Ends/ Saturday, July 9, 2016
Issued at HKT 12:00
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