(Image courtesy of Tiago Freitas - All Rights Reserved).
Recently Accutane® notified the FDA it will no longer manufacture or distribute the drug. Also known as isotretinoin, the drug has been tied to serious side effects including, but not limited, to depression, dry peeling skin and even birth defects in pregnant women. There have also been alleged issues involving colon problems.
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Is there new information leading to more dangers with Accutane®? No, the company actually claims the drug is being pulled due to declining sales. The company claims that the large number of companies offering a generic form of the actual drug since 2002 when the patents ended. The many generic offerings have diluted the market making it much more competitive for Accutane®.
As a result, the company claims their total market share has fallen to below 5%. Of course the down economy has added to the woes of the Accutane® drug. The original drug was expensive and lower-priced options have caused a loss of sales. As the economy has worsened users of the original drug have moved to generic brands with a smaller price tag.
Barr Laboratories Inc., Genpharm, Inc., Mylan Pharmaceuticals Inc., and Ranbaxy Laboratories Inc. are now the current distributers and/or manufacturers of generic isotretinoin.
As a result of publication of various side effects the company is still defending many lawsuits. Juries have already awarded at least $33 million in damages to past users who claim to develop bowel disease from the drug.
Hoffman-La Roche, Inc. (Accutane's manufacture) released a statement saying that they "stand behind the safety of Accutane and the rigorous risk management program Roche developed over decades of cooperation with the FDA and the American Academy of Dermatology."
Because of their potential side effects, generic isotretinoin products are typically not recommended unless other methods prove unsuccessful. If you suffer from serious acne, visit a dermatologist to discuss the appropriate skin care products, laser treatments and topical creams. that might work for your type of acne.
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