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Generic Accutane Remains on the Market

Accutane lawyers and those who have filed Accutane lawsuits against Roche pharmaceuticals or various generic manufacturers of the drug because of serious gastrointestinal side effects were shocked by a recent FDA decision that will allow generic manufacturers to continue to sell the drug without further testing.

Researchers in recent years have linked the use of Accutane with an increased risk of developing Inflammatory Bowel Disease, Ulcerative Colitis or Crohns Disease. Some experts also charge that Roche, the maker of the drug, knew of the dangers as early as 1986, but failed to issue any warnings. Roche discontinued sales of Accutane in June, 2009, after mounting pressure of litigation over the side effects.

As Roches patent on Accutane expired around 2002, however, several companies introduced generic versions of the drug. These versions are still available on the market. After Roche stopped sales of its drug last year, the FDA undertook an investigation to determine if a complete recall was warranted.

In its recent decision, which was posted as a notice in the Federal Register, FDA regulators ruled that the recall by Roche was not due to problems with the safety or effectiveness of the drug. This came as a shock to the thousands of people who have been affected by or filed lawsuits for inflammatory bowel disease, Crohns disease or ulcerative colitis after taking the drug.

Although the name brand Accutane is no longer available, the generic versions known as Claravis, Sotret and Amnesteem are. Under FDA regulations, the manufacturers of these drugs may continue to sell them by simply showing that they are bioequivalent, or mostly the same formula as, the original Accutane that was approved by the FDA decades earlier. If the FDA had determined that the decision to stop selling Accutane amounted to a full recall, then the generics would have been left to obtain their own FDA approval with a full application and extensive testing.

In a recent study released in the April edition of the American Journal of Gastroenterology researchers concluded that the severe side effects of Accutane increased the risk of developing Ulcerative Colitis four-fold. Drug safety advocates are now hoping that people will heed this warning and stop using the generic versions on their own, despite the questionable ruling by the FDA.