Other safety alerts
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| Canada: Health Canada to review safety of drug Diane-35 |
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Health Canada is currently conducting a review of all available safety information on the drug Diane-35. Health Canada has been monitoring the safety of Diane-35 on an ongoing basis, as it does for all drugs on the market and is aware of the decision by France to suspend the marketing authorization of Diane-35 within the next three months. In Canada, Diane-35 is approved for the temporary treatment of severe acne in women who are unresponsive to other available treatments.
Blood clots are a rare but well-known side-effect associated with oral birth control pills and other hormonal products such as Diane-35. The current Canadian Product Monograph, including the patient information section, contains clear warnings regarding this issue. Health professionals are reminded that Diane-35 should not be used in patients with a history that puts them at risk for blood clots. Known factors that increase the risk of blood clots include smoking, being overweight (obesity), and a family history of blood clots.
Health Canada has previously communicated with Canadians regarding this product. On December 19, 2002, April 10, 2003 and May 12, 2005, Health Canada issued communications advising of the increased risk of blood clots in users of Diane-35 compared to estrogen/progestogene combinations used for contraception. Health Canada also cautioned against using Diane-35 as an oral contraceptive.
Patients who think they are experiencing symptoms of a blood clot should seek immediate medical attention and mention any medications they may be taking, including Diane-35. Symptoms of a blood clot may include persistent leg swelling, leg pain or tenderness, chest pain, or sudden shortness of breath or difficulty breathing. Health Canada will take appropriate action as necessary once the review is complete.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/../2013_17-eng.php
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 and was posted on the website of Drug Office on 31 January 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 the same day. The Department of Health will keep vigilance on any safety updates of the drug and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Friday, February 01, 2013
Issued at HKT 14:30
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