SHERYL UBELACKER
From Thursday's Globe and Mail Published on Thursday, Sep. 22, 2005 3:41AM EDT Last updated on Wednesday, Apr. 08, 2009 12:40AM EDT
There is no need for Canada to follow the U.S. lead and create a registry of patients taking an anti-acne drug that causes severe birth defects, an expert advisory panel has told Health Canada.
In its question-and-answer report posted on Health Canada's website this week, the 10-member panel said it "unanimously rejected" the notion of a U.S.-style registry, which requires enrolment by thousands of American patients taking isotretinoin, the doctors who prescribe the drug and the pharmacists who dispense it.
Panel member Stuart Maddin, an emeritus professor of dermatology at the University of British Columbia, said the panel decided against recommending a registry because its operation would have to be financed by boosting the cost of the drug to patients.
A registry also would lead to fewer people being prescribed the drug -- sold in Canada as Accutane and Clarus -- because of the inconvenience of enrolment for patients, doctors and pharmacists, he said.
"[If a registry is created,] fewer people will be given the opportunity of using this medication, which is really the gold standard, the best treatment there is for the management of moderate to severe acne," Dr. Maddin said Tuesday from Vancouver. "People are not prepared today to spend the rest of their lives with scars on their face."
Furthermore, he said, the panel believes a registry is unnecessary because the number of unwanted pregnancies among Canadians taking the acne drug is low.
However, Gideon Koren, head of the Motherisk program at Toronto's Hospital for Sick Children, said of the panel's recommendations, "We are just writing ourselves a new disaster."
Dr. Koren said his program deals each year with about 14 children born to mothers who became pregnant while on Accutane -- a number he believes is only a fraction of those across Canada.
"About 50 per cent of kids exposed to Accutane in early pregnancy, which is the time when a woman may not know she's pregnant, had major malformations -- brain malformations, a lack of ears, other organ deficiencies -- very serious stuff," Dr. Koren said.
He said the panel is trying "to solve the problem by saying it does not exist or based on false numbers."
It is now up to the federal government to decide whether it will adopt some or all of the panel's recommendations, which include a call to beef up current programs aimed at eliminating the risk of unwanted pregnancy for women using the drug.
Risk management programs include educating women to take double protection during sex, including use of both a birth control pill and barrier protection, such as a condom.
Dr. Maddin said newer contraceptive measures need to be included in the patient-education programs provided by doctors and pharmacists to women using the drug. That information should be provided by the Society of Obstetricians and Gynecologists, the panel said.
"The program for pregnancy prevention is going to be tweaked and brought up to date," Dr. Maddin said, speculating that the controversial morning-after pill could be included as an option for women.
The panel also said that information on Accutane and related drugs should be made available on the Internet and perhaps through women's-health clinics.
Physician education should be expanded to ensure a greater number of family doctors are aware of risk-reduction programs, the panel said. Such programs should also be made available to pharmacists.
Dr. Koren said physician education on the drug should be mandatory.
"Unless something much more affirmatory is done, I don't think what they did will change," he said of the panel's report. "And unfortunately, more Canadian kids will be born with terrible malformations."
The panel also advised that companies bringing new generic versions of isotretinoin to the market should be obliged to provide risk-prevention programs, and a mechanism should be in place to ensure all companies comply.
Current warnings on the potential association between isotretinoin and suicide or thoughts of suicide are adequate, the panel concluded.
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