The Canadian Press - ONLINE EDITION

Health Canada reviewing safety of drug Diane-35, known to cause blood clots

  • Print

OTTAWA - Health Canada says it is reviewing all available safety information on the drug Diane-35 following France's decision to ban the medication in response to the deaths of four women over the last 25 years.

The women died of blood clots linked to their use of Diane-35, an acne drug that is also widely prescribed as an oral contraceptive because it halts ovulation. It has been sold in France since 1987.

France's National Agency for the Safety of Drugs and Health Products said this week that Diane-35, made by Bayer and licensed in 135 countries, would be withdrawn from sale in three months. Meanwhile, doctors are banned from prescribing the medication.

Available since 1998 in Canada, Diane-35 is approved only for the temporary treatment of severe acne in women who are unresponsive to other treatments, Health Canada said Thursday.

However, the drug is often prescribed "off-label" as a contraceptive.

Blood clots are a rare but well-known side-effect of oral birth control pills and other hormonal products such as Diane-35, said the federal department, noting that the product monograph for the drug contains clear warnings about this potential adverse effect.

Health Canada said Diane-35 should not be used in patients with a medical history that puts them at risk for blood clots, including smoking, being overweight or a family history of the condition.

The department has issued previous warnings about the increased risk of blood clots associated with Diane-35 compared with estrogen/progestogen contraceptives, and has cautioned against using the acne drug for birth control.

Consumers experiencing symptoms of a possible blood clot — including persistent leg swelling, leg pain or tenderness, chest pain, or sudden shortness of breath or difficulty breathing — should seek immediate medical attention.

Doctors should be told about any medications being taken, including Diane-35, Health Canada said.

Fact Check

Fact Check

Have you found an error, or know of something we’ve missed in one of our stories?
Please use the form below and let us know.

* Required
  • Please post the headline of the story or the title of the video with the error.

  • Please post exactly what was wrong with the story.

  • Please indicate your source for the correct information.

  • Yes

    No

  • This will only be used to contact you if we have a question about your submission, it will not be used to identify you or be published.

  • Cancel

Having problems with the form?

Contact Us Directly
  • Print

You can comment on most stories on winnipegfreepress.com. You can also agree or disagree with other comments. All you need to do is be a Winnipeg Free Press print or e-edition subscriber to join the conversation and give your feedback.

You can comment on most stories on winnipegfreepress.com. You can also agree or disagree with other comments. All you need to do is be a Winnipeg Free Press print or e-edition subscriber to join the conversation and give your feedback.

Have Your Say

New to commenting? Check out our Frequently Asked Questions.

Have Your Say

Comments are open to Winnipeg Free Press print or e-edition subscribers only. why?

Have Your Say

Comments are open to Winnipeg Free Press Subscribers only. why?

The Winnipeg Free Press does not necessarily endorse any of the views posted. By submitting your comment, you agree to our Terms and Conditions. These terms were revised effective April 16, 2010.

letters

Make text: Larger | Smaller

LATEST VIDEO

OT Glenn January and RB Nic Grigsby disappointed in loss to Riders

View more like this

Photo Store Gallery

  • KEN GIGLIOTTI  WINNIPEG FREE PRESS / July 23 2009 - 090723 - Bart Kives story - Harry Lazarenko Annual River Bank Tour - receding water from summer rains and erosion  damage by flood  and ice  during spring flooding -  Red River , Lyndale Dr. damage to tree roots , river bank damage  , high water marks after 2009 Flood - POY
  • Marc Gallant/Winnipeg Free Press. Local- Peregrine Falcon Recovery Project. Baby peregrine falcons. 21 days old. Three baby falcons. Born on ledge on roof of Radisson hotel on Portage Avenue. Project Coordinator Tracy Maconachie said that these are third generation falcons to call the hotel home. Maconachie banded the legs of the birds for future identification as seen on this adult bird swooping just metres above. June 16, 2004.

View More Gallery Photos

Poll

What do you think of the new Blue Bombers uniforms?

View Results

View Related Story

Ads by Google