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An 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®.

Acting in Bad Faith

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®."

Suicide, Psychosis and Depression

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.

If you are someone you love has experienced an injury from using Accutane®, please contact our experienced Accutane® lawyers now!

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