Birth Defects/Miscarriage/Spontaneous Abortion/Elective Abortion/Infant Death
Thousands of Heartbreaking Stories 
In 1995, a 24-year-old university student who was also working part time was prescribed Accutane for acne. After suffering depression and suicidal thoughts from the drug, she was advised by a psychiatrist to go off the Accutane. When she discovered she had become pregnant, doctors advised her to have an abortion because of the severe birth defects associated with Accutane. She refused. Her son was born with cerebral palsy and several other severe birth defects. Now 8-years-old, her son requires a feeding tube, is in a special education program, suffers from seizures and will need special care the rest of his life. This is just one example of the damage Accutane causes. For a comprehensive list of the kinds and types of specific Birth Defects caused by Accutane, click here.
Advice Ignored
As long ago as 1988, the consumer advocate group Public Citizen requested that the FDA pull Accutane off the market because of severe birth defects and other serious side effects associated with the drug. Also in 1988, in response to mounting numbers of Accutane birth defects, the Division of Birth Defects and Developmental Disabilities at the Centers for Disease Control wrote that "we simply need to remove the drug from the market."
In 1990, David J. Graham, Associate Director of Drug Safety at the FDA wrote that Accutane "cannot safely be given to women of childbearing age or potential" and in response to the deformities, miscarriages and abortions that resulted from the use of Accutane, stated, "There is no alternative to immediate withdrawal of Accutane from the market. To delay only compounds the body count."
As late as November of 2004, an FDA official told a Senate panel that Accutane is a drug that should be considered for withdrawal from the market.
Today, Accutane is still being prescribed and sold to thousands of women of childbearing age and is still causing birth defects, miscarriages and abortions numbering in the thousands and tens of thousands.
History
From the very beginning, Accutane has been connected to birth defects and fetal death. Perhaps most shocking is that even during its approval period, Accutane was shown to cause fetal abnormalities and birth defects in animals. The drug was approved anyway, albeit with a Category X pregnancy rating, meaning that Accutane should NOT be used by any woman who might be or become pregnant. For a more complete History of Accutane and Birth Defects, click here.
Warnings
Although they have not pulled Accutane off the market, Roche and the FDA have revised label warnings, the Accutane package insert, the Accutane consent form and other informational materials. The most recent warning reads, in part, " . . . . there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time. Potentially any fetus exposed during pregnancy can be affected."
The package insert warning reads, in part:
"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. Also, if you get pregnant while taking Accutane, stop taking it right away and call your prescriber. "
These statements are in the drug manufacturer's own words! Clearly they recognize the terrible risks associated with Accutane use, but still the drug remains on the market and still it is prescribed to women of childbearing age.
Statistics
In 1989, Dr. Edward Lammer presented data showing that up to 40% of pregnancies exposed to Accutane ended with spontaneous abortion (miscarriage). 60% of the remaining pregnancies end with induced abortion. Of the remaining pregnancies that come to full-term delivery, there is an approximately 100% chance of birth defects of varying degrees of severity.
Pregnancy Prevention
Rather than pull Accutane off the market, the FDA and Roche have modified label warnings, revised the package insert, instituted a pregnancy prevention program, and established protocols for pregnancy testing and other preventative measures. Despite all of this, the problems continue; and the March of Dimes still feels that Accutane exposes pregnant women and their fetuses to too much risk.
For more information, please visit our Birth Defects Resources page.
If you or a loved one has suffered adverse pregnancy consequences from Accutane, please call or e-mailus for more information, and we will evaluate your Accutane claim for free.