Sharon Kirkey
CanWest News Service
Monday, April 17, 2006
Health Canada is investigating reports of strokes and heart attacks in people taking Accutane, the controversial acne drug that causes birth defects and has been linked with psychiatric problems.
Twenty-nine cases of patients who developed a vascular disorder after
taking isotretinoin, the generic name for Accutane, have been reported since the
drug was approved in Canada in 1983.
Eleven involved strokes, blood clots or a heart attack, none of which are labelled as possible reactions in the drug's prescribing information. The patients ranged in age from 15 to 48.
One 18-year-old with no known risk factors suffered a stroke two months after starting the drug.
"Health-care professionals are encouraged to report any cases of myocardial infarction, cerebrovascular and thromboembolic disorders suspected of being associated with isotretinoin," a new Health Canada report on adverse drug reactions says.
Canadian retail pharmacies filled 224,515 prescriptions for Accutane last year, worth $33.8 million, according to IMS Health Canada. Isotretinoin's use is expected to grow as cheaper generic versions reach the market.
Beginning in December 2005, new regulations will require doctors and patients to register in an electronic database before the drug can be dispensed. The plan also includes two pregnancy tests, two birth control methods and other previously recommended safeguards.
On August 12th the FDA announced that starting December 31, 2005, thousands of Accutane users, plus the doctors who prescribe it and stores that sell it, must enroll in a national registry that ensures they understand all the drug’s risks, and take special steps to avoid the most notorious one, Accutane-damaged pregnancies.
If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities. The drug may also trigger or worsen depression or suicidal thoughts, according to a warning on the pills’ label that the FDA strengthened Friday and that patients are to receive as part of the new program.