Health Canada Warns Accutane Patients About SJS

February 19, 2010, 8:00AM. By Gordon Gibb

Ottawa, ONA number medications have been linked to the serious skin disease Stevens Johnson Syndrome (SJS). This week the Canadian government added one more potential medicinal hazard to the list.

Health Canada has issued a warning about Isotretinoin, which is marketed as Accutane and is also available in generic form. Used to treat acne, Accutane is extremely effective and quite popular. However, health officials are concerned that in rare cases isotretinoin can cause serious damage to the skin it is prescribed to treat.

According to the 2/16/10 issue of the Globe and Mail, Roche Canada has received 66 reports globally of severe skin reactions to isotretinoin, including several cases of Stevens Johnson Syndrome. SJS causes the outer layer of the skin to blister and separate in large sloughs from the dermis, or underlying layers of skin, similar to a severe burn. Roche Canada reports two of those cases resulted in death.

Health Canada has even fewer reports to go on. It cites just two cases of skin-related adverse reactions in the 27 years since Accutane first became available in Canada in 1983. Agency spokesperson Dave Thomas reiterated in an email that "the benefits of Accutane continue to outweigh the risks if used appropriately, as directed in the Canadian Product Monograph."

Still, health officials in Canada thought there was sufficient risk to warrant an alert. "If patients notice any of the 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."

Early signs include the development of a rash, peeling skin, fever, malaise and irritated eyes. Blisters or sores can develop on the legs, arms or face, as well as sores in the mouth, throat, nose or eyes.

Accutane has been in the news before, according to the Globe and Mail report. Some pregnant women who were taking the medication in the early 1980s suffered 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, most famously the late 17-year-old son of Bart Stupak, a well-known US Congressman and crusader who blamed isotretinoin for his son's suicide.

There has been no definitive link established between Accutane and suicide. A spokesperson for Roche Canada stressed that millions around the world have taken the drug successfully—and that while adverse reactions should be taken seriously, they remain rare.

Meanwhile, a jury in New Jersey has awarded an Alabama man $25.16 million after he alleged that the Accutane he took for acne in his 20s was responsible for his inflammatory bowel disorder. Andrew McCarrell, now 38, eventually had to get his colon removed. McCarrel was initially awarded $2.6 million in May 2007, but the judgment was overturned on appeal. In a retrial, a jury issued a compensatory damages judgment against Accutane manufacturer Hoffmann-La Roche Inc. for $25.16 million. The manufacturer has said it will appeal the judgment, according to the New York Times,

While Hoffman-La Roche stopped selling Accutane in June of last year, it is still available in Canada. The US-based manufacturer cited generic competition and the costs associated with lawsuits alleging suicidal behavior and birth defects.