FDA Drug Information Sheets

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Click Here for FDA Medication Guides - FDA-Approved Patient Labeling

Patient Package Inserts: For some prescription medicines, FDA approves special patient materials to instruct patients about the safe use of the product. These materials may be given to patients by their health care provider or pharmacist, and are considered part of FDA-regulated product labeling.

Medication Guides: FDA may require distribution of Medication Guides, FDA-approved patient information, for selected prescription drugs that pose a serious and significant public health concern. Medication Guides will be required if the FDA determines that one or more of the following circumstances exist:

• patient labeling could help prevent serious adverse effects,
• the drug product has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients' decision to use, or to continue to use, the product;
• the drug product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness.

DailyMed - The new format is important to the success of other initiatives aimed at improving patient care and decreasing the likelihood of medication errors. For example, the recently launched DailyMed, a health information clearinghouse created by FDA and the National Library of Medicine, has begun to electronically disseminate (via http://dailymed.nlm.nih.gov) up-to-date and comprehensive medication information for use with information systems that support patient care. The DailyMed will make current information about FDA-regulated products readily available, free of charge, to physicians, other healthcare professionals, and patients. This is an important step toward creating electronic access to drug safety and effectiveness information so that prescribers can get up-to-date information at the point of care.