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Off-label drug use: The Cytotec controversy

On Behalf of | Apr 16, 2015 | Birth Injuries |

Off-label drug use is an issue that concerns many New York residents. According to the Mayo Clinic, this phrase describes the practice of using a drug for a purpose that is not listed on the label. The United States Food and Drug Administration only approves pharmaceuticals for the uses that are on these labels. As such, any off-label drug use has not been vetted through the FDA’s approval process.  

According to an article in the Journal of Perinatal Education, physicians’ off-label use of a drug named Cytotec has stirred controversy. The FDA approved the drug for ulcer treatment, but it is also administered as a method of inducing labor in pregnant women.

In discussions about Cytotec, the case of Tatia Oden French is often cited. The JPE article states that French was a healthy 32-year-old woman. She was pregnant with her first child and went to a well-respected hospital for her delivery. While she was about two weeks overdue, her pregnancy had been free of complications. At her physician’s insistence, French was given Cytotec. Despite the fact that inducing labor is an off-label use of the drug, French was told that its use was “the standard of care.” French and her child were dead 10 hours later. Their deaths were attributed to Cytotec.

The American College of Obstetricians and Gynecologists has fought efforts to reduce the use of Cytotec for pregnant women. The manufacturer of the drug, Searle, sent a letter to thousands of American OB/GYNs describing the dangers of using Cytotec for pregnant women in August 2000. In response, the ACOG refuted the claims, stating that there was insufficient evidence to halt its off-label use.

The author of the JPE article supports halting the use of Cytotec in pregnant women, citing the drug’s unnecessary risks.