Drugs

Change Labeling for Hormonally Active Contraceptives: Petition

David McFarland

— 2 min read
Share

The Contraceptive Study Group says additional Warnings and Safety Information should be added to the labeling for hormonally active contraceptives. In a petition, the group says the contraceptives have been on the market for 50 years, and in that time, numerous studies have documented side effects that can have a serious impact on health.

The petition says the study group performed a series of comprehensive literature surveys to better understand the immediate and long-term side effects of the agents, and that review led to these recommendations:

  • add a Warning for a significantly higher risk of developing inflammatory bowel disease, especially Crohn’s disease, but also ulcerative colitis;
  • add a Warning for a significantly higher risk of developing systemic lupus erythematosus;
  • add Safety Information and a Warning on a significantly higher risk for developing multiple sclerosis;
  • add Safety Information and a Warning on a significantly higher risk for developing interstitial cystitis;
  • add Safety Information on a significantly higher risk for developing several inflammatory conditions; and
  • add Safety Information on a significantly higher risk for infectious diseases.

The petition says the Contraceptive Study Group initially submitted a petition in 2019 to update the prescribing information for hormonally active contraceptives. It cites FDA’s 5/17/2022 response, which was limited to breast cancer risk and did not address other risks. It says the 2026 petition includes newer information that was not addressed. The petition says the study group strongly urges FDA to require that users of hormonally active contraceptives be fully informed of all potential risks for which substantive data exists.

“Hormonally active agents have a variety of effects on various organs and organ systems which may result in a deleterious impact on women’s health,” the petition concludes. “It is important to stress that these agents are generally not used to treat or prevent a disease, disorder, or pathology, but are used by healthy women to avoid pregnancy by suppressing ovulation. As such, the safety requirements for these agents should be much more stringent than other medications which are used to treat or prevent a disease, disorder, or pathology. The data reviewed … reflects a vast body of information which has come to light since the introduction of these agents as contraceptives. While the information for patients and prescribers currently reflects many of the known side effects, others have come to light which are not adequately represented in the current prescribing information. These should be added and made obvious to patients.”

The petition also urges FDA to require manufacturers of the affected agents to widely publicize the additional risks.

Read more