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We feel that the commentary by Gideon Koren and associates1 regarding safety concerns related to isotretinoin has the potential to serve as a catalyst for safer use of this drug.
We concur that proper measures to prevent pregnancy in patients taking isotretinoin must be in place and that such measures must be user-friendly for both the health care provider and the patient. Implementation of safety measures should be consistent and universal, regardless of whether (or how many) generic forms of the drug have been authorized on the Canadian market. Currently, no approved generic isotretinoin products are available on the Canadian market, but approval of such generics would require a patient information program equivalent to the program now in effect for Accutane.
Health Canada attended the US Food and Drug Administration (FDA) advisory committee meeting on this subject in February 2004 and is aware of the FDA's proposal for tighter control of prescription of these drugs. Although the FDA had access to information suggesting a significant rate of pregnancy among women taking isotretinoin in the United States,2,3 Health Canada's pharmacovigilance program, which includes but is not restricted to spontaneous reporting of adverse drug reactions and review of periodic safety update reports by the manufacturer, has shown no evidence of a comparable situation in Canada.
Part of Health Canada's mandate is to convey information that will minimize the risks and maximize the benefits of pharmaceutical products on the Canadian market. However, it will take more than regulatory due diligence to solve safety problems related to isotretinoin: endorsement of existing recommendations through physicians' daily practice remains an essential ingredient. Patients must also play an active role: once informed of a potential risk, their behaviour and compliance with the contraceptive methods become part of the equation, and closer follow-up must be planned if there is suspicion of noncompliance. The patient–physician–regulator triad is pivotal in optimizing the safe use of isotretinoin, as for any pharmaceutical product.
Footnotes
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Competing interests: None declared. The views expressed are those of the authors and do not necessarily reflect those of Health Canada.