Health Canada has announced that Accutane, a popular medication used to treat acne, must now carry a warning stating the medication may cause rare, but potentially fatal skin reactions. The new warning stems from reports that some patients taking the medication have developed severe skin conditions such as toxic epidermal necrolysis and Stevens-Johnson syndrome.
A total of 66 serious skin reactions, two of which resulted in fatality, have been reported globally in patients taking the medication. According to Health Canada, the number of reported events presumably underestimates the number of Accutane patients that have experienced such reactions. While most of the reported occurrences involved factors other than Accutane, a correlation between the medication and the severe reactions has not been ruled out.
In the more than 25 years in which Accutane has been in circulation, the medication has been prescribed to approximately 16 million patients. During this time Accutane has been associated with other serious side effects such as the development of severe birth defects and miscarriage when taken by pregnant women. It has also been linked to an increase in depression and suicidal thoughts in some patients.
The maker of the drug, Hoffmann-La Roche, quietly pulled Accutane from the U.S. market and those of 11 other countries in 2009, citing growing competition from generics and a burdening string of law suits involving Accutane against the company.
Despite the new warning, Health Canada believes no additional action against Accutane is warranted and maintains the benefits of the medication still outweigh the risks.
For information about Stevens Johnson Syndrome visit www.milnesjs.com
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