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Accutane: a Miracle Drug to Cure Acne or Deadly Remedy?

Posted in Drug Companies, Miscellaneous on 5/1/08

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To most users, Accutane, one of the most potent, effective weapons against acne, is a miracle drug. But, to others Accutane leads to a life filled with pain and discomfort and in some cases, death.

First introduced in 1982 by the drug maker Hoffman-La Roche, Acctutane became of their top sellers with an estimated 1.2 billion dollar in sales.Despite reports as early as 1984 of serious adverse reactions including miscarriages and birth defects, the FDA decided to allow the sale of Accutane relying on doctors’ discretion and wisdom to properly prescribe the drug. Other adverse effects include inflammatory bowel disease, Crohn’s Disease, suicide, loss of bone density and bone fractures, muscle weakness, chapped lips and nose bleeds, Hoffman-La Roche refused to recall their product.

The side effects related to Accutane are so severe that the FDA now requires all patients who take Accutane to sign a consent form. Since 1996, pharmacists are required to give patients a Medication Guide which details the risks. Thalidomide and Mifeprex are the only other drugs that have required a Medication Guide.

In 1997 European authorities placed strict controlling measures on Accutane because of reports of serious psychiatric disorders associated with the drug. But, it wasn’t until the death by suicide in May 2000 of Michigan Congressman Bart Stupak’s son, BJ while taking the drug, that public awareness of the dangerous link between Accutane and suicide emerged. In response, a spokesperson for Roche claims that it has been used safely by over 13 million patients and that severe acne in itself can cause depression.

So, you decide…is Accutane a miracle cure or deadly remedy?

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