Other safety alerts
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| Updates on the use of Diane 35 and generics |
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1. European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Agency for the Safety of Medicine and Health Products (ANSM) unexpectedly announced today the decision to suspend the marketing authorisations of these medicines in France.
The French decision comes at a time, when the process is not yet complete as the PRAC recommendation is the first step towards a common EU approach.
The European Medicines Agency reiterates the PRAC recommendation that, provided a number of measures are taken to minimise the risk of thromboembolism, Diane 35 and its generics can be used in the treatment of moderate to severe acne related to androgen-sensitivity and/or hirsutism (excessive unwanted growth of hair) in women of reproductive age. Furthermore, Diane 35 should only be used for the treatment of acne when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed.
The PRAC recommendation will now be considered by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). If a position by this group is not reached by consensus, it will then be considered by the European Commission, who will adopt a final decision. Once a final decision is adopted, all Member States must follow it.
Please refer to the following website in EMA for details:
http://www.emea.europa.eu/../news_detail_001794.jsp&mid=WC0b01ac058004d5c1
2. Health Canada's review of Diane-35 supports current labelling and use
Health Canada’s review of the safety of the anti-acne medication Diane-35 has found that the drug’s benefits continue to outweigh the risks, when used as authorized.
In Canada, Diane-35 is approved for the temporary treatment of severe acne – with associated symptoms of high levels of male hormone, including seborrhea (oily skin) and mild hirsutism (excessive body hair) – in women who are unresponsive to other available treatments. It should not be used in patients with a history that puts them at risk for blood clots, and is not approved for use as an oral contraceptive.
Health Canada began its current review in February 2013, following the decision by France to suspend the marketing authorization for Diane-35. Health Canada found that the available scientific information supported the authorized use and the safety information provided in the Canadian Product Monograph for Diane-35.
The Department recognizes that the European Medicines Agency (EMA) has also been evaluating the safety of Diane-35. The EMA Pharmacovigilance Risk Assessment Committee has posted today its recommendations for consideration by their decision making body. The Committee proposed an update to the authorized use in Europe that is similar to the drug's authorized use in Canada.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../29283a-eng.php
3. UK Medicines and Healthcare Products Regulatory Agency issued a statement on Dianette (Same composition as Diane-35)
The MHRA have responded to the recommendations of the European Medicines Agency’s (EMA) pharmacovigilance risk assessment committee (PRAC) on Diane 35 – known as Dianette.
Dr Sarah Branch, the MHRA’s Deputy Director for Vigilance and Risk Management of Medicines, said:
"In the UK, Dianette is an effective medicine for treating the distressing conditions of severe acne and excessive undesirable hair in women. Our advice is that there is no need for a woman who is feeling well to stop taking her medicine. If any woman has concerns about her treatment she should contact her doctor."
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/NewsCentre/Whatsnew/CON273741
In Hong Kong, Diane-35 Tab (HK-43330) is registered by Bayer Healthcare Ltd and there are other nine generic products with same ingredients registered in Hong Kong. All are prescription-only medicines and have package inserts including precaution of blood clot. Related news has been released by the European Medicines Agency, Health Canada and Therapeutic Goods Administration of Australia, and was posted on the website of Drug Office on 31 January, 1 February, 6 February and 9 February 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 31 January 2013. In light of the announcements by EMA, Health Canada, and UKMHRA, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The Department of Health will continue to keep vigilant on any safety updates of the drug and actions taken by other overseas regulatory authorities.
Ends/ Saturday, May 18, 2013
Issued at HKT 12:30
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