Acne treatment Accutane was popular and widely sold in the United States for more than 20 years. It had entered the market soon after it was approved by the Food and Drug Administration on May 7, 1982. But on June 29, 2009, Accutane creator Roche Pharmaceuticals pulled the product from the market.
Why? Because of competition and because of Accutane lawsuits. Here’s how the situation evolved:
First, Accutane clearly was shown to cause serious gastrointestinal disorders, including inflammatory bowel disease (IBD), Crohn’s Disease and Ulcerative Colitis, or UC. Other harmful Accutane side effects include but are not limited to irritable bowel syndrome (IBS), liver damage and suicidal impulses.
Accutane also can cause severe health crises for infants whose mother took acne medication Accutane during pregnancy. That can result in mental retardation and difficulties with sight and hearing.
But among the most damaging Accutane side effects are the IBDs known as Crohn’s Disease and Ulcerative Colitis. Each can produce debilitating and lifelong health problems requiring repeated and costly surgeries.
As a result, more than 5,000 Accutane lawsuits for personal injury are in the works against Roche Pharmaceuticals, and still more are coming. Americans should not have to pay the price for the negligence of Roche Pharmaceuticals, which has reaped billions of dollars in profits by selling its defective acne treatment.
Such Accutane lawsuits have deterred Roche from continuing to sell the long profitable defective drug, as did the fact that in 2002 Roche lost its exclusive patent of the product. Since then, various cheaper forms of generic Accutane entered the market to compete, including such brands as Sotret, Amnesteem and Claravis.
All contain the generic drug Isotretinion, as did Accutane. That drug boosts the body’s Vitamin A and helps ease acne problems. But it also leads to the harmful Accutane side effects noted above, including IBD or inflammatory bowel disease.
Yet even though Roche has stopped producing Accutane due to these factors, and even though Accutane remains a dangerously defective drug, generic Accutane products remain available, including Claravis, Sotret and Amnesteem. The FDA has required a so-called “black box warning” on these products, yet they remain legal to sell.
It’s argued that the label’s warning is not emphatic enough, and thus people still use defective generic Accutane products such as Sotret, Claravis and Amnesteem. These, too, may cause Accutane side effects injuries which can spur Accutane lawsuits across America.