Patients: If you have a medical emergency call 911
It is our policy to provide technical information on prescription products to Pharmacists and Physicians only. Patients/consumers should contact their HealthCare Provider with any questions regarding prescription products and their uses.
Patient Information Sheets encourage patients to talk with their healthcare providers for further information. Patient Information Sheets also provide telephone and e-mail contact information for FDA’s Drug Information line to address specific questions. FDA continues to collect input on the usefulness of these consumer communications through feedback mechanisms, such as focus groups, surveys, and public meetings, and anticipates that these consumer communications will continue to evolve.
Source: Drug Safety Information- FDA’s Communication to the Public.
21 CFR section 208.1(c) authorizes FDA to require a Medication Guide if FDA determines one or more of the following circumstances exist:
(1) The drug product is one for which patient labeling could help prevent serious adverse effects.
(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risks could affect patients’ decision to use, or continue to use, the product.
(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.