Which type of medication requires a patient package insert?

Estrogen-containing medications require a patient package insert to provide important information regarding risks, benefits, and safe use. The requirement for a patient package insert is mandated by the FDA for certain categories of medications, particularly those that present significant risks. Estrogen-containing products, which include hormone replacement therapies and contraceptives, can have serious side effects and require detailed and specific patient education to ensure that patients are aware of the potential risks, including the increased risk of thromboembolic events and certain types of cancer.

While not all medications require patient package inserts, that requirement is specifically applied to certain FDA-approved products, such as those containing estrogen. This is crucial for promoting informed decision-making among patients using these medications. Other types of medications, such as over-the-counter drugs, generally do not necessitate patient package inserts, as the information is typically provided on the product label itself.