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drug_recall accutaneIn September 1983, a little over a year after Accutane became available, Pubic Citizen consumer group petitioned the FDA for warning labels due to the high risks of birth defects and other side effects. By 1990, after various warning amendments had been made, an FDA memo concluded that the magnitude of Accutane death and injury was great, noting the 11,000 to 13,000 Accutane related abortions and 900 to 1,100 Accutane related birth defects. The risks of Accutane death and injury were high, but 1996 FDA documents showed that more than 90 percent of females treated with the drug did not even have severe cystic acne.
In 1997, French health authorities required Roche to add warnings of suicide attempt to Accutane''s side effects, but Roche did not tell the FDA of the French concerns for risks of Accutane deaths. A few months later, the agency issued a warning letter to Roche for failing to submit serious adverse event reports in a timely manner but still was unaware of the French warning. The agency concluded in a 1998 memo that Roche had not acted in good faith and recommended "active consideration of removal of Accutane from the market."
By 1998, the FDA required Roche to add bold face warnings to Accutane physician package inserts of risks of depression, psychosis, and rarely suicidal ideation, suicide attempts, and suicide. Family members of suicide Accutane victims later spoke out against the 1998 FDA added warnings of possible Accutane deaths claiming physicians never warned of these potential effects. In the U.K. and Ireland, similar Accutane warnings were added in March 1998.
Weeks after the strengthened warning was added, the FDA issued a warning letter to Roche because of false and misleading advertisements that minimized the suicidal risks that could possibly lead to Accutane deaths. Almost one and a half years after the French warning was issued, the FDA finally became aware of the action that was based on a 1992 to 1994 French study of Accutane''s association with depression. The lawsuits that have arisen from Accutane deaths have been controversial for the lack of conclusive evidence the FDA has found to occur between Accutane use and suicide versus the family members that argue there was no previous history of depression prior to the use of the acne medication.
Distressed family members have claimed that despite the reports and signs of serious and potentially deadly effects, their doctors failed to warn of these events that could result in Accutane deaths. Surviving friends and family also questioned the FDA''s 18-year delay in adding the warning while preventable Accutane deaths, birth defects, and injury were occurring. By 2002, there had been over 200 suicides associated with Accutane, just one percent of the actual number of suicides believed to have occurred due to underreporting. Accutane deaths and birth defects have been a concern for decades, and the FDA announced in March 2004 that stiffer restrictions were being considered.
Consumer groups and families have been outraged at the lack of FDA regulation in what many consider a reckless allowance of a drug on the market. Both Roche and the drug agency have received criticism for its failure to adequately warn consumers of the risks of possible Accutane deaths and birth defects despite having this information for years.
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...