One of Accutane's most serious side effects is its tendency to cause birth defects. Defects that Accutane has been linked to:
- Mental Retardation (Manufacturer Hoffman La Roche's own warning label states that cases of IQ scores less than 85 have been reported)
- Learning Disabilities
- Hydrocephaly and Microcephaly (abnormally large and small heads)
- Hearing and Vision Irregularities
- Heart Defects
- Seizures
- Feeding Problems
In addition to these serious problems, women who become pregnant while taking Accutane also suffer a high rate of miscarriages (spontaneous abortion) and premature births. The risks for the unborn child of Accutane users is so great that many women choose to abort their fetuses before coming to term.
The Associated Press has reported that in the 20 years since Accutane's introduction in 1982, the FDA was notified of 2,181 women who became pregnant while on Accutane. Those pregnancies resulted in 1,310 elective abortions, 242 spontaneous abortions, 192 normal babies born, and 166 reports of babies born with abnormalities.
There is also mounting evidence that the defects associated with Accutane can be passed on paternally. This means that even if the mother is not taking Accutane, a child may still be affected by the father's Accutane usage. There is debate over whether Hoffman La-Roche is giving men proper warning for this possibility.
The risks associated with becoming pregnant while taking Accutane are so great that the FDA has taken the remarkable step of requiring each dose of Accutane to come with a Medguide, listing these side effects (the only other drugs to ever require a Medguide are Thalidomide and Mifeprex [mifepristone]). The following are quotes directly from the FDA Medguide:
"Accutane can cause birth defects (deformed babies) if taken by a pregnant woman. It can also cause miscarriage (losing the baby before birth), premature (early) birth, or death of the baby. Do not take Accutane if you are pregnant or plan to become pregnant while you are taking Accutane. Do not get pregnant for 1 month after you stop taking Accutane.
Accutane can cause severe birth defects in babies of women who take it while they are pregnant, even if they take Accutane for only a short time. There is an extremely high risk that your baby will be deformed or will die if you are pregnant while taking Accutane. Taking Accutane also increases the chance of miscarriage and premature births.
Do not breast feed while taking Accutane and for 1 month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby."
In addition, the FDA was forced to create the SMART program (System to Manage Accutane-Related Teratogenicity) because women were continuing to get pregnant while using Accutane. The program requires females 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 consent forms that they will use at least 2 forms of birth control while using Accutane.
Perhaps the most distressing part of Accutane's tendency to cause severe birth defects is the fact that Hoffman La-Roche has been aware of this for more than 20 years.
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.
