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drug_recall accutaneAn Accutane withdrawal has never occurred, but many critics of the FDA believe it may have if the agency was able to enforce safety decisions. The power of large pharmaceutical drug companies and the politics of the industry have allowed Accutane to remain on the market despite FDA indication that an Accutane withdrawal may occur. Approved in 1982, the FDA showed concern early on about Accutane and hinted that an Accutane withdrawal could occur after links to fetal death and birth defects were found to occur in women using Accutane.
The FDA believed Accutane maker Hoffman-La Roche did not act in good faith by failing to communicate the dangers of using Accutane in female patients. The agency recommended a consideration for an Accutane withdrawal in a 1998 memo. The drug company responded by creating the SMART program to reduce the number of women using Accutane from suffering from a fetal death or birth defect. When the reports of adverse effects continued, an FDA official wrote in 1990 that, "intensive regulation has not, cannot, and will not achieve the Agency''s goal of eliminating pregnancy exposure to Accutane."
Even with continued reports of suicide, psychosis, and depression made among Accutane users, an Accutane withdrawal was never issued and sales continued to be high. Accutane was being prescribed for off-label use at an estimated 90% of Accutane use according to the FDA, though no type of Accutane withdrawal occurred, just new warnings. Due to the birth defects, links to suicide and psychosis, and other adverse effects, Congressional hearings have been held to discuss safety concerns with parents and consumer groups pushing for an Accutane withdrawal.
Thirty-six-year-old Andrew McCarrell of Moody, Alabama was awarded $119,000 for his past medical expenses and $2.5 million in compensatory damages to cover his future medical costs and for pain and suffering in a jury verdict awarded yesterday. His law...
A new study warns that approximately one in three patients who took the acne drug Accutane experienced a rise in cholesterol levels and more than 40 percent showed increased levels of triglycerides, or blood fats—a higher percentage than what previous ...
Ever since Accutane made its 1982 U.S. debut, intended to treat severe forms of acne that failed to respond to other treatments, it has been the source of medical and regulatory controversy. Now, a Florida lawsuit against Accutane drugmaker Hoffmann-L...