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CBC MARKETPLACE: HEALTH » ACCUTANE
American Accutane rules tightened
Producer: Christian Côté | Researcher: Colman Jones
Broadcast: February 6, 2001
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"At the present time we have not made any decision. It is still under review." says Dr. Brian Gillespie, Health Canada's senior medical advisor

The numbers in the United States are more dramatic than those in Canada. In the U.S., more than 1,300 psychiatric side effects and as many as 66 suicides have been reported since Accutane arrived on the market. The numbers prompted the Food and Drug Administration to take another look at Accutane.

The FDA did take another look, and changed its rules regarding the drug. American doctors must now get patients to sign a consent form - a form produced by Accutane's maker, Hoffman LaRoche.

The form says the patient understands all the risks associated with Accutane, including depression and suicide.

Pharmacists must also hand out a detailed warning brochure from the FDA, called a 'Medguide.'

Accutane is one of just three drugs in the United States that has ever been required to come with a Medguide.

The rules in Canada aren't nearly as stringent. In 1998, Hoffmann LaRoche sent out a letter to dermatologists and updated the drug monograph for doctors, warning that reports of depression, psychotic symptoms and -in rare cases- suicide attempts and suicide had been reported in patients treated with Accutane.

A brochure put out by Accutane's maker for patients still makes no mention of the reports of depression or suicide. The brochure does caution those who feel depressed or suicidal to contact their doctor.

Marketplace invited Hoffmann LaRoche to speak with us on camera for this story. They refused. But in a letter to Marketplace they explained their product information "is approved and regulated by Health Canada."

Health Canada information out of date

So what does Health Canada tell consumers about Accutane? Its website includes information that is more than eleven years old. There is no warning about the reports of depression or suicide.

Dr. Brian Gillespie, Health Canada's senior medical advisor, says there are plans to update the information on the website. The department, he says, is also in the process of determining whether Hoffman LaRoche will have to strengthen the warnings on Accutane sold in Canada.

"We're examining that issue, and as to whether or not in the Canadian context it would enhance adherence to the warnings and precautions that are in the Accutane prescribing information," Gillespie told Marketplace. "At the present time we have not made any decision, it is still under review."

Ottawa dermatologist Dr. Elgin Duke says it's ultimately up to doctors who prescribe Accutane to make their patients aware of the risks.

"As far as the depression is concerned, I discuss it with the patient, but I now ask a member of the family to be present when we discuss it," Duke explained.

"I want a father, brother, mother, somebody to be aware that a personality change and depression may occur. It's an extremely rare risk and it's not a reason to not take the drug, but if they notice any change then we would stop the drug and look for some alternative."

Duke believes dermatologists in Canada are warning their patients, but he's not so sure about the increasing number of family doctors who are prescribing Accutane.

Marketplace conducted a small survey of Toronto area doctors who prescribe Accutane to find out what kinds of warnings they are giving their patients.


"I think that people should know about it ... I don't want people to make the same mistake I did"
Erin Daines, who overdosed on Tylenol while on Accutane treatment

Of ten doctors, only one said he warned patients about the link to depression and suicide. Some said they weren't aware of such a link and others did not think it was that serious. (For Canadian Medical Association response to the Marketplace survey of doctors, click here.)

Nancy Daines says doctors should know better. She wants Health Canada and Hoffmann LaRoche to offer the same warnings to Canadians now being given Americans.

"Some kids could die," Daines told Marketplace. "Depression … runs high with teens on a normal basis, so if they do happen to be taking this medication, they should definitely be very cautious about it."

Her daughter Erin agrees. "I think that people should know about it," Erin says. "I don't want people to make the same mistake I did."

NEXT: Accutane facts and figures »


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ACCUTANE: MAIN PAGE AMERICAN ACCUTANE RULES TIGHTENED ACCUTANE FACTS AND FIGURES CMA RESPONSE TO OUR SURVEY U.S. AND CANADIAN WARNINGS

MORE MARKETPLACE: MARKETPLACE ARCHIVES: YOUR HEALTH
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EXTERNAL LINKS:

CBC does not endorse and is not responsible for the content of external sites. Links will open in new window.

Hoffman LaRoche Canada

Information about Accutane for patients [PDF] - from Hoffman LaRoche

Letter from Roche Laboratories, Inc. to healthcare providers and pharmacists

New Accutane Medication Guide (U.S.), January 22, 2001 [Roche Laboratories, Inc.]

Revised Informed Consent Form (U.S.), January 22, 2001 [Roche Laboratories, Inc.]

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee meeting on isotretinoin (Accutane)

Accutane/RoAccutane Action Group

"Accutane avengers", discussion group on adverse side effects linked to Accutane/RoAccutane

Accutane Discussion Board

Absolute Acne - information about 'natural acne treatment'

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