Other safety alerts
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| European Union: European Medicines Agency recommendation on the use of Linoladiol N and Linoladiol HN estradiol-containing creams |
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The EMA’s Committee for Medicinal Products for Human Use (CHMP) has updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.
In December 2013, the CHMP had concluded a review of the benefits and risks of both creams and made recommendations on their use. Following a request by the company for a re-examination of Linoladiol N, the recommendations for this cream have now been updated, taking into account new measures to manage the potential risk of side effects.
The CHMP reiterates the need to limit treatment with both creams to 4 weeks because of their relatively high estradiol content and the potential risks of side effects from estradiol being absorbed systemically (throughout the body). Systemic absorption of estradiol may be associated with risks similar to those seen in systemic hormone replacement therapy (HRT), including blood clots, stroke and endometrial (womb) cancer. The product information of Linoladiol N and Linoladiol HN have been updated to inform patients and healthcare professionals about these potential risks.
In addition, for Linoladiol N, the cream with the higher amount of estradiol, the CHMP has required the company to limit the amount of cream available in the packs to prevent patients from using them for longer than recommended.
The EMA has concluded a review of Linoladiol N and Linoladiol HN estradiol-containing creams and has updated recommendations on their use. The product information for both creams will be updated with the following recommendations:
• Linoladiol N is indicated for the treatment of vaginal atrophy due to estrogen deficiency in postmenopausal women.
• Linoladiol HN is indicated in the short-term treatment of acute, mild inflammatory skin diseases of the external genital area in postmenopausal women.
• Linoladiol HN should no longer be prescribed for lichen sclerosus.
• Both Linoladiol N and Linoladiol HN should not be used beyond four weeks due to the risks associated with possible systemic exposure to estradiol.
The CHMP’s recommendations will now be sent to the European Commission for the adoption of a final, legally binding decision to be valid throughout the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002086.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, the above products are not registered pharmaceutical products. Related news has been released by the EU EMA and was posted on the website of Drug Office on 21 December 2013.
Ends/ Saturday, April 26, 2014
Issued at HKT 12:30
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