HEADLINES:
R/€ 
R/£ Hazardous acne drug still available in SA
Product withdrawn in US owing to many side effectsNovember 11, 2009 Edition 1
Gill Gifford and Shari Roan/Los Angeles Times
It has been found to cause serious bowel disorders, birth defects and possibly an increase in the risk of depression and suicidal behaviour - and in the US it is no longer available at pharmacies.
But Roaccutane will not be taken off pharmaceutical shelves in South Africa soon.
According to reports, drug manufacturer Roche pulled the blockbuster acne drug, sold as Accutane in the US, amid early signs that it may be linked to inflammatory bowel disease - although the company claims it was discontinued because competition from four other generic brands meant it was no longer commercially viable.
However, a new study has since quantified the risks, finding that users of the medication have almost twice the odds of developing a serious bowel disorder as non-users.
While the generic versions are still available in the US, there is a chance that this could lead to the withdrawal of the controversial medication considered the treatment-of-last-resort for severe acne.
Accutane costs about $1 200 (R8 900) a month, and many consumers choose the generics, which cost 25 to 50 percent less.
Meanwhile, plaintiffs have won an estimated $33m in judgments against Roche for bowel disorders, according to an industry publication, the Dermatology Times.
Despite its tumultuous 25-year history, the drug (also known known as isotretinoin) is still available in South Africa and in a number of other countries, such as Switzerland.
According to Roche, Roaccutane is available only on a doctor's prescription.
"It would be a true disaster if this medication would become unavailable," said Dr Steven Stone, chairman of an American Academy of Dermatology committee that has reviewed the drug's safety.
"People don't die of acne, so it's easy to say 'Let's take if off the market'. But that ignores the psychological harm of severe acne."
Accutane/Roaccutane itself has been used by more than 13 million people worldwide and was one of Roche's best-selling drugs, with about $200m a year in sales before its patent expired in 2002. When approved in 1982, the drug was known to cause birth defects if taken during pregnancy. Isotretinoin can also cause increased sensitivity to the sun, joint and muscle pain, headaches, thinning hair, elevated cholesterol levels and liver toxicity.
The drug has also been linked to an increased risk of depression, including suicide. However, a recent study found that the relationship between isotretinoin and psychiatric problems has not been proved.
Last week, at the annual meeting of the American College of Gastroenterology in San Diego, researchers from the University of North Carolina presented evidence showing a higher rate of bowel disorders in isotretinoin users.
In inflammatory bowel disease, the intestines become chronically red and swollen, producing pain, cramping, diarrhoea, weight loss and bleeding. Surgery to remove all or part of the colon is sometimes necessary.
But only about five to 10 people among 100 000 a year were diagnosed with inflammatory bowel disease, said Seth Crockett, a doctor heading the research.
Meanwhile, Roche has stated that there are no plans to withdraw the product from the South African market.
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