Comments of the Patient, Consumer, and Public Health Coalition on Drug Interactions with Hormonal Contraceptives

December 15, 2015. As members of the Patient, Consumer, and Public Health Coalition, we support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling.

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NCHR at FDA Meeting on Essure Contraceptive

September 24, 2015. If the product is to be on the market, who should do the studies to accurately determine the short-term and long-term effectiveness and side effects? The company’s track record and response to the women’s reported complications is not acceptable. Any additional research should be conducted independently of the company so that patients can have confidence in its accuracy.

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