Accutane use has been linked to severe birth defects in users that are Accutanepregnant or within a month of becoming pregnant. Accutane can cause birth defects even if taken once or in small doses during pregnancy. There is also a risk of birth defects if you take Accutane 30 days before getting pregnant.

Birth defects resulting from pregnant women taking Accutane include:

  • severe fetal brain and heart defects
  • external abnormalities of the eyes, ears and skull
  • mental retardation
  • miscarriage

Birth Defect Results

Despite the warnings, reports indicate that about 2,000 pregnant women take Accutane. At a recent FDA meeting, it was disclosed that about 25% of babies born to mothers taking Accutane have serious birth defects and 50% of the children suffer from mental retardation. Unfortunately, many women that become pregnant while taking Accutane decide to terminate their pregnancies because of the high occurrence of birth defects. The use of Accutane while pregnant also increases the risk of a miscarriage threefold.   

Control of Accutane Birth Defects

In 1983, within a year of Accutane hitting the market, a consumer advocacy group, Public Citizen, petitioned the FDA to force Hoffman-LaRoche, Accutane’s manufacturer, to place a label on the drug warning users of possible birth defects. In 1988, the birth defect problems escalated and Public Citizen petitioned for a ban on Accutane use. The FDA did not act on these requests but in 1998 it did inform Hoffman-LaRoche that the continuing rate of birth defects may force them to withdraw Accutane from the market.

Accutane Users Registry

    In response to the increasing complications and birth defects in Accutane users, Hoffman-LaRoche worked with the FDA to create the SMART program (System to Manage Accutane Related Teretogenicity). This program urged women to take a voluntary pregnancy test before using Accutane and attend contraception education classes to prevent these tragic birth defects. Women partaking in the program also signed a registry pledging to not become pregnant while taking Accutane to prevent giving birth to a child with birth defects. Despite the good intentions of the SMART program, there were 61 reported pregnancies ending in 48 elective abortions during the first year.

FDA Implements iPLEDGE to Curtail Birth Defects

The FDA passed the iPLEDGE program to halt the birth defects caused by women taking Accutane while pregnant. This program requires pharmacists, wholesalers and patients to register in the iPLEDGE registry in order to give or receive an Accutane prescription. Female patients that want an Accutane prescription must show a negative pregnancy test and agree to use two contraceptives to avoid becoming pregnant and placing their unborn child at risk of developing birth defects. 

Injured by Birth Defect

If you or a loved one has been injured by a birth defect or complication due to Accutane, or if you would like more information about Accutane side effects, please contact us today.

Published November 17, 2011 by