OTTAWA, Jan. 31, 2013 /CNW/ - 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. The Department 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
SOURCE: Health Canada
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