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
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Health Canada information out of date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?
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
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.
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.
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."