Accutane Recall
Accutane Recall
In 2009, Roche AG, the makers of Accutane announced that they were recalling the drug from the market in the US and 11 other countries. Many believed that Roche AG made this decision because of mounting exposure to legal liability. However, a Roche AG representative stated that the decision to recall Accutane was related to economic concerns. They pointed to the growing number of generic equivalents of Accutane that had been released by rival drug companies in recent years. The FDA issued a notice stating that it had found neither safety nor effectiveness to be the reason for Accutane’s recall from the market.
Accutane Side Effects
Accutane was originally approved for sale in the United States by the FDA in 1982. For a time, Accutane was extremely successful. It eventually came to dominate the acne medication market for several years. However, by the late 1980's, the reports began to surface about serious side effects involved in the use of Accutance.
These Accutane side effects included cardiovascular issues, kidney problems, pancreas problems, psychiatric problems, severe birth defects, liver problems, central nervous system damage and auto-immune deficiencies. All of these side effects were severe when experienced by patients. Perhaps the most remarkable of the initial side effects were hundreds of reports that people had experienced psychiatric distress so severe that they committed suicide. Unfortunately, suicide related to the use of Accutance has since been a problem that continues to grow, as more Accutance related suicides have occurred in recent years.
Recently, reports again began to surface regarding the side effects of Accutane, although these conditions were very different than the side effects reported years earlier. These more recent Accutane side effects include ulcerative colitis, Crohn's disease and inflammatory bowel disease. Accutane side effects have caused damage to the intestines, colons, and bowels of those who used the drug.
Accutane Lawsuits
Because of the increasing number of reports of Accutane side effects, Roche AG began to experience significant legal problems. The FDA took action before Accutane was eventually recalled from the market. Roche AG was ordered to attach a clear warning label to bottles of Accutane that clearly indicated the risk of side effects linked to the drug.
As many as 5,000 Accutane related lawsuits have already been filed against Roche AG by plaintiffs across the United States. Several enormous verdicts have been returned for patients that held Roche AG liable for the injuries that they had suffered. Roche AG faces nearly 1,000 lawsuits regarding inflammatory bowel disease from Accutane. These cases involve allegations that Roche AG failed to warn patients about the risk of debilitating bowel problems, such as ulcerative colitis and Crohn’s disease, from the use of Accutane. The company has so far lost all Accutane bowel disease trials that have reached a jury, with verdicts for plaintiffs totaling more than $56 million. These Accutane settlements and verdicts cast a negative light on Roche AG and has shown that many additional Accutane lawsuits could arise over the years, given the high number of people who have taken drug.
