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# FDA Denies Part of Contraceptive Study Group Petition
- URL: https://www.fdaweb.com/fda-denies-part-of-contraceptive-study-group-petition/
- Published: 2022-05-18T12:00:00.000Z
- Updated: 2026-09-14T17:45:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151841

FDA has denied a request in a 5/9/19 petition submitted by Dr. **William Williams** of the Contraceptive Study Group asking that a Boxed Warning be added to prescribing information and patient-related materials for all combined hormonal contraceptives (CHC) on an increased risk of breast cancer. The agency [response](https://downloads.regulations.gov/FDA-2019-P-2289-0183/attachment%5F1.pdf?ref=fdaweb.com) says other requests in the petition will be addressed at a later date.

“We do not agree … that a Boxed Warning regarding breast cancer risk is appropriate for the CHC product class,” the letter says. “However, based on the agency’s review of relevant scientific literature, FDA approved a safety labeling change for CHCs on 4/29 to better reflect the agency’s current assessment of breast cancer risk associated with the use of these products.”

The agency response says that taken as a whole, the weight of the evidence based on the studies cited in the petition does not support the claim that CHC use is associated with a significant risk of breast cancer.