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Drugs, chemicals, radiation & herbal products in pregnancy: Panel seeks more action on Accutane

MD says better program could protect unborn babies of women on drug

By Celia Milne

TORONTO | Canada is not adequately protecting unborn babies from the dangers of Accutane.

So ruled a Scientific Advisory Panel on Isotretinoin set up by Health Canada, which recommended this country beef up its risk management programs for the teratogenic acne drug. But it rejected the idea of establishing a registry for users and prescribers of isotretinoin like the one in the U.S.

The panel suggested late last month that the core elements of a better program include a physicians' checklist, a patient consent form, a toll-free number, a Web site, pregnancy testing and voluntary education for family doctors. Dr. Gideon Koren, director of the Motherisk program at the Hospital for Sick Children in Toronto, said the recommendations do not go far enough. "This is disappointing because special education and better labelling is beating on dead horses."

Special education of physicians should be mandatory, according to Motherisk. "Voluntary education won't do it," said Dr. Koren. "We are seeing increasing numbers of babies malformed."

He suggested that doctors interested in prescribing isotretinoin (sold in Canada under the names Accutane and Clarus) take a brief educational program culminating in a test, which could be offered online. "If you pass, you print your own certificate; if you fail, you have to spend more time," he said.

The course would be similar to that required to get a Canadian boating licence. "Why not have this for such a drug that damages unborn babies? For a typical physician it would take about 20 minutes and then 10 minutes to answer questions," said Dr. Koren. Rules for prescribing isotretinoin would be similar to those for methadone.

Prescriptions of isotretinoin have more than doubled in the last decade, a statistic that worries Dr. Koren because about 50% of fetuses exposed to isotretinoin in the first trimester will have major malformations. Cognitive defects are another possible effect.

Isotretinoin is a drug of particular concern to Motherisk for several reasons: the exclusive patent for Accutane has run out, allowing generics to enter the market; prescribing the drug is increasingly being done by family physicians; and new off-label uses for the drug have emerged.

In the last year and a half, Motherisk received 14 calls from women who had become pregnant while on the drug. Not all cases are reported to Motherisk, so the numbers may be higher. "This is a totally unacceptable risk," he said.

The next step is for Health Canada to decide if it will adopt some or all of the recommendations of the panel. This will be done "in the coming months," according to a spokesperson for Health Canada.

Currently, the government requires that women taking isotretinoin give written informed consent, be made aware of the teratogenicity of the drug and agree to using two contraceptive methods while on the drug.

A similar program in the U.S. was ruled by the FDA to be insufficient, and today physicians and patients must be registered before prescribing or using isotretinoin. The Canadian panel unanimously rejected the idea of adopting such a registry here.

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