Although Accutane has been available to consumers in the US for more than 20 years, it is only recently that manufacturer Hoffman-La Roche has strongly emphasized the dangers the drug could have for pregnant women and their unborn children. The question is when did Hoffman-La Roche actually know the drug was dangerous?
The truth is that Hoffman-La Roche was aware of the potential for severe birth defects before the drug was approved for sale. In 1982, the FDA approved Accutane for the US Market but gave it a Category X rating which means that it had been shown to cause birth defects in animals. By July of 1983, at least three cases of birth defects directly related to Accutane usage were known, prompting the Public Citizen consumer watchdog group to petition the FDA to require Hoffman-La Roche to place warning labels in Accutane packaging.
With evidence of the link between Accutane and birth defects mounting, the FDA held committee meetings over the next several years and recommended that warnings for Accutane be strengthened.
In 1988, an internal report recommended that Accutane be considered for removal from the market as an "imminent hazard". In response, the FDA required Hoffman-La Roche to develop a new warning label. The language for this label included a recommendation that women who become pregnant while using Accutane should consult their physician about the "desirability of continuing the pregnancy".
Hoffman-La Roche's approach to the problem was two-fold: try to prevent women from getting pregnant while taking Accutane, and if that failed, encourage them to have abortions. There was no effort to modify the drug itself so that side effects could be prevented. The problem with this approach is that even with education and warnings, women can get pregnant by accident. Did Hoffman-La Roche realize this? Yes. In 1989, it was revealed that in clinical trials before the drug was approved in 1982, 5% of women taking Accutane became pregnant. Hoffman-La Roche knew the risks involved for pregnant women and knew that women taking the drug may still become pregnant by accident.
Compounding the issue was the fact that La Roche failed to implement an acceptable program to prevent pregnant women from taking the drug. The organization made an attempt in 1988 with its "Pregnancy Prevention Program" which included very basic attempts to inform physicians (not consumers) of Accutane' birth injury risks. This program was a failure as the number of women who got pregnant while taking the drug and the number of babies born with birth defects increased.
The FDA and Hoffman-La Roche finally developed the SMART (System to Manage Accutane-Related Teratogenicity) program in 2000. It took almost twenty years to initiate an appropriate safety program that would adequately warn women of the birth defects and other complications that occur when using Accutane.
These steps were not enough, as changes to the SMART program were made in late 2002. The program now requires women to undergo a rigorous screening process before being allowed to use Accutane, including providing proof that they have had 2 negative pregnancy tests before using Accutane, and providing consent forms that they will use at least 2 forms of birth control while using the drug.
It took Hoffman-La Roche 20 years to effectively warn women of the terrible risks of Accutane. Unfortunately, these new warnings will not prevent birth defects from occurring, nor will it provide any comfort to the families of babies who have already been born with horrendous injuries.
If you or a loved one have taken Accutane and have experienced any side effects including birth injuries, miscarriages, depression or even suicidal behavior, contact us immediately at 800-966-4999 and see why our law firm has recovered over $100 million on behalf of our clients.
