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Controversial acne drug available in SA
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| November 11 2009 at 09:51AM |
Get IOL on your mobile at m.iol.co.za |
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Submit your comment By Gill Gifford and Los Angeles Times
In a statement issued in the US, Roche said its decision to withdraw Accutane reflected market pressures and the cost of lawsuits, not safety concerns. Plaintiffs have won an estimated $33-million (about R244m) in judgements against Roche for bowel disorders, according to an industry publication, Dermatology Times. Continues Below ↓ In its tumultuous 25-year history, the drug (also known known as isotretinoin) has been found to cause serious birth defects and possibly to increase the risk of depression and suicidal behaviour. Yet Roaccutane was still available on the South African market, and in a number of other countries such as Switzerland, Roche said yesterday. According to Roche, Roaccutane is a prescription-only product that cannot be bought over the counter and is available only to patients taking it under the supervision of their doctors. But the fact that it is still on the market puzzles some former users and consumer advocates - and reflects the profound lengths to which doctors, pharmacists, pharmaceutical companies, regulatory agencies and patients have gone to ensure its survival. "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, 'This is a drug that causes inflammatory bowel disease; 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 and was labelled with warnings to that effect. In 2005, the US Food and Drug Administration implemented the stringent iPledge programme, requiring patients, doctors and pharmacists to join a risk-management registry to try to ensure that women did not become pregnant while on the drug. "This drug has had so many fears associated with it over the years," said Dr Amy Forman Taub, a dermatologist and assistant clinical professor at Northwestern University in Chicago. Apart from inflammatory bowel disease, isotretinoin can cause a range of other side effects, including increased sensitivity to the sun, joint and muscle pain, headaches, thinning hair, elevated cholesterol levels and liver toxicity. The drug also has been publicly and emotionally linked to an increased risk of depression, including suicides, and some families of suicide victims have pressed the Food and Drug Administration for its removal. A study published in the Annals of General Psychiatry in January, however, found the relationship between isotretinoin and psychiatric problems had not been proved. Now research has found a possible link to inflammatory bowel disease. Last week, at the annual meeting of the American College of Gastroenterology in San Diego, researchers from the University of North Carolina, Chapel Hill, presented evidence showing a higher rate of bowel disorders in isotretin-oin users. Before the study, the connection was largely anecdotal. In inflammatory bowel disease, the intestines become chronically red and swollen, producing cramping, diarrhoea, weight loss and bleeding. Surgery to remove all or part of the colon sometimes is required. Dr Seth Crockett and his colleagues compared 8 189 cases of inflammatory bowel disease with 21 832 healthy individuals and found the odds of developing such diseases were 1,68 times higher among isotretinoin users. People who had filled four or more prescriptions had increased odds of 2,67. The odds of having ulcerative colitis, a type of bowel disease that causes open sores in the lining of the rectum and colon, were 4,36 times higher among isotretinoin users. The risk of having Crohn's disease, the most severe of the diseases, was not increased. But only about five to 10 people among 100 000 a year were diagnosed with inflammatory bowel disease, Crockett said. "The absolute risk of getting inflammatory bowel disease is very low," he said. "So if someone has disfiguring acne that was affecting their quality of life, it might be a risk they are willing to take." But because the data had not yet been published in a peer-reviewed journal, Crockett noted, it must be considered preliminary. A similar study, published in July in the American Journal of Gastroenterology by University of Manitoba researchers, found no such association. Roche has stated there are no plans to withdraw or discontinue Roaccutane from the South African market.
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SUBMIT YOUR COMMENT!
Showing page 1 of 1 comment pages, 3 total comments
1 Week ago Anonymous wrote :
I was on it twice and although I welcome increased testing for long term effects I agree that for some people this drug is a welcome relief. Can't say I don't get depressed and all that... but they who can really? The papers are depressing!
1 Week ago Anonymous wrote :
In 2001, I consulted a Dermatologist and he prescribed Roacutane, which my Medical Aid then didnt cover as it costed about R1000-a-month, for atleast 6 mths. Do we have an alternative or generic drug that can be covered by Discovery on KeyCare plus? Advice please as I'm still suffering from severe acne at the age of 31.
1 Week ago Lizzy wrote :
Long live Roaccutane!! Inflammatory bowel disease can be treated. The psychological effects of acne cannot be traeted. I was on Roaccutane at age 19, and it changed my life. Now, my daughter aged 15, is on Roaccutane, and it too is having a life-changing effect on her.
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