Celebrity Worried About Accutane Birth Defects

Hollywood, CASinger Toni Braxton recently penned in her memoir that she took Accutane while she was pregnant and the possible birth defects associated with the acne medication was one reason she had an abortion.

The 46-year-old Grammy award-winner said she had an abortion 10 years ago, according to The Raw Story (May 24, 2014). She also wonders if God was punishing her for having an abortion by inflicting autism (which Braxton later corrected to learning difficulties - as told to People magazine) on her 11-year-old son.

Many Accutane users are surprised and shocked that the acne medication is so powerful. Like many other drugs, it was first used for something completely different (e.g., Chantix, prescribed to quit smoking, was first approved as an antidepressant), and often used “off-label.” Accutane was first developed as a chemotherapy medication for the treatment of pancreatic cancer, brain cancer and other cancers. In 1982, the FDA approved its use to treat acne.

Braxton is correct in worrying about the acne medication. The risk of Accutane birth defects and miscarriage is so great that doctors are known to prescribe two kinds of birth control to women to ensure they don’t get pregnant while taking the drug. The chemicals in Accutane attack rapidly reproducing cells such as those cells of a developing fetus.

In 1985, the FDA slapped Accutane with a black box warning, stating that “Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount.” (Drugwatch lists possible birth defects that can happen as a result of taking Accutane.)

Fast-forward to 2000: an FDA advisory committee and Roche, the Accutane manufacturer, agreed on a program to ensure no woman should begin Accutane therapy if she is pregnant and no pregnancies should occur while a woman is taking Accutane. The S.M.A.R.T (System to Manage Accutane Related Teratogenicity) program was initiated, replacing the Accutane Pregnancy Prevention Program put in place in 1989. Under the SMART program, patients were required to sign consent forms, watch informational videos, take a pregnancy test and use two forms of birth control before obtaining a prescription for Accutane. Unfortunately, the program was unsuccessful: it was replaced by iPLEDGE in 2006, which required pregnancy tests from doctor’s offices and patient registration by computer.

Still, the average rate of fetal exposure was three per every 1,000 patients. Since 1988, the Center for Disease Control reported severe birth defects caused by Isotretinoin (Accutane is the brand name).

Fortunately, Accutane is no longer available in the US but people can still obtain it online (even on ebay), and it is still prescribed in some countries, including Canada.