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Roche Holding AG has pulled its oral acne medication Accutane (isotretinoin) from the US market, which could pave the way for its increased topical use or for the development of new topical treatments for severe acne. A report in the August 2009 issue of Dermatology Times adds that dermatologists are also concerned that generic isotretinoin products could experience the same fate as Accutane.
According to the report, Roche stated that the safety of Accutane was not the reason for its removal from the market but instead, the product was pulled since generic competitors had taken over the drug's marketshare. The company stands behind its risk management program.
The product was removed from the market after US$33 million was awarded in damages for some 5,000 personal injury claims of users experiencing bowel disorders they attributed to the drug. Some users reported the drugmaker failed to properly warn that the medicine could cause inflammatory bowel disease. The drug is also claimed to be linked to birth defects and depression.
Roche notified the US Food and Drug Administration (FDA) on June 26, 2009, of its withdrawal of Accutane from the market. The drug also has been pulled from the markets of 11 other countries including France, Denmark, Austria, Germany, Portugal, Norway and Spain, although it is still distributed outside of the United States as Roaccutane. Approximately 13 million consumers have used Accutane since it launched on the market in 1982.
Originally Roche developed the oral isotretinoin product; however, when the company's patent expired in 2002, generic versions of the product were launched by competitors. In addition to oral isotretinoin, topical isotretinoin acne treatments have been developed such as Isotrex and Isotrexin from Steifel.