Accutane linked to severe skin reactions

Rare but potentially deadly skin reactions have been found in people using Accutane to treat severe acne, Health Canada says.

The department, in consultation with the drug's manufacturer, Hoffmann-La Roche, released the public advisory on Tuesday.

"There have been very rare post-marketing reports of severe skin reactions," Health Canada said in a letter to health-care professionals.

"These events may be serious in nature and can result in hospitalization, disability or death," it added in its advisory to the public.

Accutane (isotretinoin) was approved in 1982 to treat the worst cases of acne that cannot be cleared up with other treatments.

People who are taking Accutane or used it recently and developsymptoms should stop using the drug and see their doctor immediately. Symptoms can include:

• Rash, especially if associated with fever and/or malaise or conjunctivitis (red or inflamed eyes, like "pink eye").
• Blisters on legs, arms or face and/or sores in mouth, throat, nose or eyes.
• Peeling skin.

Severe skin reactions can start with mild symptoms such as fever, malaise, chills, aching muscles, headache, sore throat or stinging eyes. It can take up to three days for skin lesions to develop, Health Canada said.

Accutane has been prescribed over the last 25 years to about 16 million people. As of Nov. 6 ,2009, there have been 66 cases of severe skin reactions reported in both adults and children worldwide, based on a review of the company's global safety database.

The skin reactions are known as erythema multiforme (EM) and Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

While other factors were involved for the majority of these reports, an association between Accutane and severe skin reactions cannot be ruled out, the department said.

The company will update the product's monograph toinclude this safety information.