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Information update

Health Canada's review of Diane-35 supports current labelling and use

Starting date:
May 17, 2013
Posting date:
May 17, 2013
Type of communication:
Information Update
Source of recall:
Health Canada
Important Safety Information
General Public
Identification number:


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.

Blood clots are a rare but well-known side-effect associated with hormonal products such as Diane-35. The “boxed warning” in the Product Monograph for Diane-35 highlights this risk. Known factors that increase the risk of blood clots include smoking, being overweight (obesity), and a family history of blood clots.

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/progestogen combinations used for contraception. Health Canada also repeated that Diane-35 should not be used as an oral contraceptive.

What you should do

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.

Report health or safety concerns

  • Call toll-free at 1-866-234-2345
  • Visit Health Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
(613) 957-2983

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(613) 957-2991
1-866 225-0709