It's helped countless Canadians struggling with severe acne, but now Health Canada is issuing a warning about potentially serious side effects associated with a popular prescription medication.
Isotretinoin, sold under the brand name Accutane has been linked to rare, but severe, skin reactions that could lead to hospitalization, disability or death.
Health Canada said it will require the drug maker to update the product label to include the new warning, but that it doesn't believe the risks are significant enough to warrant further action.
"Health care professionals should monitor their patients closely and consider discontinuing Accutane if warranted," Health Canada spokesman Dave Thomas wrote in an e-mail. "The benefits of Accutane continue to outweigh the risks if used appropriately, as directed in the Canadian Product Monograph."
Roche Canada, which sells Accutane in this country, said it has received 66 reports globally of severe skin reactions associated with the drug, such as Stevens-Johnson Syndrome, in which the outer layer of skin becomes separated from the dermis, or underlying skin layers. Two of the cases resulted in death.
The drug, which is also available in generic forms in Canada, is also associated with erytheme multiforme and toxic epidermal necrolysis.
Health Canada said it has received two reports of "serious skin-related adverse reactions" since the drug was put on the market here in 1983.
While the reactions are rare, officials are warning the public to immediately stop taking Accutane and see their doctor if they develop a rash, particularly if it's associated with fever, malaise or irritated eyes, blisters or sores on the legs, arms or face, as well as sores in the mouth, throat, nose or eyes, as well as peeling skin.
"If patients notice any of these early signs, they should remain vigilant," Mr. Thomas wrote in an e-mail. "If concerned, patients may stop the medication and consult a doctor at any time, even in the absence of a skin reaction."
It's just the latest in a string of problems associated with the popular acne medication. Some pregnant women who were taking the medication in the early 1980s had miscarriages, premature births or children born with birth defects. The problems led to warnings and restrictions on how the drug is prescribed to women.
Accutane has also been linked to depression and suicide in some patients, although there has been no definitive link proven.
The drug has been the subject of several lawsuits from individuals and families who say it led to suicide. Perhaps the best known case is that of U.S. Congressman Bart Stupak, who blamed the drug for his 17-year-old son's suicide.
Samantha Ouimet, director of corporate affairs for Roche Canada, said that it's often difficult to identify the cause of depression and pointed out that people struggling with severe acne may be more vulnerable.
Ms. Ouimet said that Accutane has been taken by millions of people around the world since it was first introduced. While the risks need to be taken seriously, she highlighted the fact problems are typically rare.
"It has helped a lot of people and been very valuable for people," she said.
Carly Weeks