Injuries Caused by Accutane®
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An AccutaneŽ 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 AccutaneŽ to remain on the market despite FDA indication that an AccutaneŽ withdrawal may occur. Approved in 1982, the FDA showed concern early on about AccutaneŽ and hinted that an AccutaneŽ withdrawal could occur after links to fetal death and birth defects were found to occur in women using AccutaneŽ.
The FDA believed AccutaneŽ maker Hoffman-La Roche did not act in good faith by failing to communicate the dangers of using AccutaneŽ in female patients. The agency recommended a consideration for an AccutaneŽ withdrawal in a 1998 memo. The drug company responded by creating the SMART program to reduce the number of women using AccutaneŽ 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 AccutaneŽ."
Even with continued reports of suicide, psychosis, and depression made among AccutaneŽ users, an AccutaneŽ withdrawal was never issued and sales continued to be high. AccutaneŽ was being prescribed for off-label use at an estimated 90% of AccutaneŽ use according to the FDA, though no type of AccutaneŽ 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 AccutaneŽ withdrawal.
If you are someone you love has experienced an injury from using AccutaneŽ, please contact our experienced AccutaneŽ lawyers now!
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