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Accutane Linked to Serious Birth Defects and Complications

Accutane was approved by the U.S. Food and Drug Administration (FDA) in 1982 to treat severe cystic acne that has been unresponsive to previous treatments. However, the drug has been under scrutiny as it has been related to serious adverse effects, including severe birth defects and suicidal depression. The FDA has ordered updated labeling and increased patient education in order to decrease the risks associated with Accutane.


In 2005, the U.S. Food and Drug Administration implemented the iPLEDGE risk management program in order to better educate female consumers of the risks associated with becoming pregnant while using Accutane.

According to the federal regulator, fetal exposure to isotretinoin, the active ingredient in Accutane, can cause severe birth defects, miscarriages, premature birth, and infant death. As such, the FDA urges female patients to use at least two effective types of contraception while taking Accutane. Further, it is recommended that female patients initiate contraceptives use one month prior to beginning treatment with Accutane and continue contraceptive use for one full month after discontinuing treatment with Accutane.

The FDA released another alert in 2005 with the goal of mitigating suicide risks in patients taking Accutane. According to the FDA alert, patients are to be monitored for effects such as depression or suicidal thoughts, including sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, decreased school or work performance, or trouble concentrating.

Upon experiencing any of these symptoms, patients are advised to discontinue treatment with Accutane and seek further evaluation from their physician.


According to DrugCite, common adverse side effects associated with Accutane are:

  • Inflammatory Bowel Disease
  • Colitis Ulcer
  • Depression
  • Irritable Bowel Syndrome
  • Anxiety
  • Intestinal Hemorrhage
  • Colitis
  • Suicidal Ideation
  • Dry Skin
  • Headache
  • Dry Lip
  • Back Pain
  • Birth Defects


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