Health Canada to Review Diane-35 [Canada]


Canada/Ottawa: Health Canada to review safety of Diane-35, a hormonal treatment for severe acne in women. HCSC: http://ht.ly/hlHYK

Direct link:
http://hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2013/2013_17-eng.php

Additional information:
Health Canada has been monitoring the safety of Diane-35 on an ongoing basis and is aware of the decision by France’s Health Department to suspend the marketing authorization of Diane-35 within the next three months. On three separate occasions, Health Canada has 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 previously cautioned against using Diane-35 as an oral contraceptive.

HCSC recall number: 2013-17
Recalls Direct RIN: 2013-1506

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