Health Canada to post medication safety reviews online

First safety review to be made public relates to acne drug Diane-35

TORONTO – Health Canada says it will begin posting summaries of drug safety reviews on its website to better inform the public about potential harms associated with certain medications.

Federal Health Minister Rona Ambrose announced the program — called the regulatory transparency and openness framework and action plan — on Tuesday in Ottawa.

Health Canada conducts a review of a drug when a safety issue is identified by patients, health-care providers or the manufacturer.

The safety review summaries will detail the department’s findings and decisions in plain language, with the aim of helping consumers make informed decisions about taking a drug.

Toronto pharmacology expert Dr. David Juurlink says the initiative is a good start, but he questions how complete and transparent the information will be.

Ambrose says the first safety review to be made public relates to the acne drug Diane-35, which can cause potentially fatal blood clots in some patients.

The Diane-35 summary also includes a checklist to guide health providers through the decision to prescribe the drug to their patients. The checklist also will reinforce existing warnings and precautions for the drug, Health Canada said.

While approved in Canada for the treatment of severe acne, Diane-35 is often prescribed to women “off-label” as a contraceptive

While approved in Canada for the treatment of severe acne, Diane-35 is often prescribed to women “off-label” as a contraceptive because it halts ovulation. The drug has been linked to a number of deaths worldwide.




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