Accutane Birth Defects

Accutane birth defects have been a well-known Accutane side effect, however Hoffmann-La Roche failed to strongly emphasize the dangers that Accutane can cause in pregnant woman. Well before Accutane received FDA approval, the manufacturers knew about accutane birth defects that could occur with use, causing them to delay marketing pursuits for over ten years. Following FDA approval in June 1982, the FDA received three reports of birth defects linked to Accutane use by July 1983, resulting in Public Citizen consumer group petitioning the FDA to require birth defects warning labels on Accutane.

An FDA memo written in 1998 concluded the Accutane manufacturer had not acted in good faith regarding Accutane and the risk of Accutane birth defects. Not until the FDA recommended steps to remove Accutane from the market due to the birth defects that Roche finally proposed a more aggressive educational push to inform patients of the potential Accutane birth defects.

The FDA issued yet even stronger Accutane birth defects warnings on the labeling, but by 1990, the number of birth defects due to Accutane use remained very high. The FDA included in a 1990 Accutane related memo that birth defects as a result of Accutane had affected 900-1,100 births and was responsible for 11,000-13,000 Accutane related abortions.

In 2001, research suggested that women were still not adequately receiving the message of the risks of birth defects when using Accutane. In the January/February 2002 FDA Consumer magazine, the FDA announced that the SMART program, originally launched in 2000 was being strengthened in attempts to drastically reduce the number of birth defects resulting from Accutane use. It has taken nearly twenty years for a program to be put into place while women on Accutane failed to understand the severity of birth defects that could occur if using the acne medication when pregnant.

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