Accutane Side Effects Include Birth Defects

Although much of the media coverage surrounding Accutane is based on the recent and ongoing lawsuits surrounding the acne medication, and most of these lawsuits relate to the gastrointestinal side effects of the drug, another serious side effect of Accutane has been clear since the drug’s introduction to the market in the 1980s – Accutane-related birth defects. An average mother’s chance of giving birth to a baby with a birth defect is 3-5 percent, but when Accutane is added to the equation, the percent chance increases to 30 percent – more than ten times what it would normally be. Birth defects such as vision problems, heart problems, and mental retardation have all been reported as a result of Accutane use.


Fortunately, the Food and Drug Administration has taken steps to reduce the problem – in 2000, they introduced a program called S.M.A.R.T. (System to Manage Accutane Related Teratogenicity) that required potential female Accutane users to confirm with a doctor that they were not pregnant before receiving their Accutane prescription. In 2006, the FDA increased conscientiousness about the issue, introducing a program called iPLEDGE – in this system, women have to prove they are not pregnant with at least two consecutive tests and agree to using at least two forms of birth control before they can fill an Accutane prescription.

Accutane was pulled from the United States market in 2006 by its manufacturer, Roche, but the generic form of the drug – isotretinoin – is still available, with women continuing to be required to participate in the iPLEDGE program. Thankfully, this has greatly reduced the risk of Accutane- and isotretinoin-related birth defects, although there is still some risk – the internet has made illegal generic isotretinoin available from overseas without a prescription, and there is a possibility that a pregnant woman could access the powerful medication this way without having to go through the iPLEDGE program.