Inflammatory Bowel Disease Not the Only Adverse Reaction To Accutane

Ottawa, ONEarlier this month Health Canada alerted consumers to a "very rare" skin reaction linked to the use of Accutane. The reaction, said Health Canada, could lead to hospitalization, disability and even death.

According to the 3/18/10 edition of the Prince George Citizen of British Columbia—with reporting by the Canadian Press—the federal department of health for the Canadian government issued the advisory on March 16. Health Canada said anyone who recently took or is currently taking Accutane should stop the drug and see their doctor immediately if any of the following symptoms develop:

- Rash, especially if associated with fever and / or malaise or conjunctivitis (red or inflamed eyes, such as pink eye)
- Blisters on the legs, arms or face, and / or sores in mouth, throat, nose or eyes
- Peeling skin

Severe skin reactions can begin with mild, non-specific symptoms such as fever, malaise, chills, aching muscles, headache, sore throat or stinging eyes. Health Canada noted that it could take up to three days for skin lesions to develop.

The Canadian health authority said that the rare condition, which it did not identify by name, has affected 66 individuals worldwide.

The recent news about skin rash and irritation only adds to existing concerns surrounding the drug and its relation to Inflammatory Bowel Disease (IBD). A man who suffered severe complications from IBD recently sued Accutane manufacturer Hoffman-La Roche and was awarded $25.16 million in damages. It was revealed during the trial that Hoffman-LaRouch possessed the results of studies confirming that Accutane damages the gastrointestinal tract and leads to degeneration and erosion of the intestinal lining—a trigger for IBD.

While Hoffman-La Roche duly alerted the medical community with regard to the potential for Accutane IBD, the manufacturer allegedly failed to strengthen warnings over the potential for Accutane Inflammatory Bowel Disease.

The US Food and Drug Administration (FDA) is of the position that drugs may remain on the market provided the benefits outweigh the risks. Hoffman-La Roche voluntarily withdrew Accutane from the US market in June of last year, citing a diminished market share from generics and the costs associated with litigation. However, Accutane remains available in Canada. The Canadian Health authority previously issued an alert with regard to Accutane and Stevens Johnson Syndrome in February.

Accutane has been prescribed to approximately 16 million people around the globe over the past 25 years for the treatment of severe acne.