Off-Label Drug Uses

Generali, Joyce A.; Cada, Dennis J.
October 2009
Hospital Pharmacy;Oct2009, Vol. 44 Issue 10, p868
Academic Journal
This Hospital Pharmacy feature is extracted from Off-Label Drug Facts, a quarterly publication available from Wolters Kluwer Health. Off-Label Drug Facts is a practitioner-oriented resource for information about specific drug uses that are unapproved by the US Food and Drug Administration. This new guide to the literature enables the health care professional or clinician to quickly identify published studies on off-label uses and determine if a specific use is rational in a patient care scenario. A summary of the most relevant data is provided, including background, study design, patient population, dosage information, therapy duration, results, safety, and therapeutic considerations. References direct the reader to the full literature for more comprehensive information before patient care decisions are made. Direct questions or comments regarding Off-Label Drug Uses to hospital pharmacy@drugfacts.com.


Related Articles

  • FDA gives off-label guidance a reboot. Weinstein, Deborah // Medical Marketing & Media;Apr2014, Vol. 49 Issue 4, p19 

    The article reports on the forum hosted by the U.S. Food and Drug Administration (FDA) for comments about off-label drug promotion with the release of its draft guidance.

  • Off-label prescribing might get boost from FDA. Edlin, Mari // Managed Healthcare Executive;Apr2008, Vol. 18 Issue 4, p26 

    The article focuses on the new draft guidance that would enable pharmaceutical companies to give physicians journal articles that explain product uses that are not yet approved by the U.S. Food and Drug Administration (FDA). The new guidance would serve as replacement for the FDA Modernization...

  • Safety: labeling updates & new warnings.  // Formulary;Dec2007, Vol. 42 Issue 12, p664 

    The article provides information on the labeling of drugs requested from the Food and Drug Administration (FDA) to the manufacturer. It presented the information of medicines including the Rosiglitazone (Avandia), Erythropoiesis-stimulating agents (ESASs) and likewise the marketing suspension of...

  • Off-label drug use. Goldberg, David J. // Dermatology Times;Dec2008, Vol. 29 Issue 12, p8 

    The article discusses the use of off-label drugs for the purpose not approved by the U.S. Food and Drug Administration (FDA). The case of Doctor Head who use botulinum toxin to treat migraine headaches is presented. It points that the Courts and the FDA deals the challenge to balance the...

  • FdA-Approved drugs: A Potential Source of off-Label Alzheimer's Treatments?  // Mind, Mood & Memory;Apr2012, Vol. 8 Issue 4, p1 

    The article discusses investigations that involve the off-label use of drugs whose safety and efficacy have been demonstrated for a different medical condition as a more efficient way for identification of drugs that slow or reverse the progression of Alzheimer's disease (AD). With the drugs...

  • Pharma Gets Reprieve on Reprints. Weschler, Jill // Pharmaceutical Executive;Feb2009, Vol. 29 Issue 2, p14 

    The article reports on a Food and Drug Administration (FDA) policy in the U.S. that permits dissemination of medical journal articles discussing unapproved drug uses. This revised policy is said to drop a requirement that the FDA review journal articles before health professionals can handle...

  • Science, Empiricism, and Off-Label Use. Hogan, Janice M. // Pharmaceutical Technology;Apr2008, Vol. 32 Issue 4, p106 

    The author reflects on the decision of the U.S. Food and Drugs Administration (FDA) regarding draft guidance on off-label information. She states that the Congress and FDA have made several attempts to deal with off-label use, however, none of these attempts as yet have been successful....

  • Drug firms seek off-label help from FDA. Arnold, Matthew // McKnight's Long-Term Care News;Aug2011, Vol. 32 Issue 8, p29 

    The article reports on a citizen petition filed by seven drug firms with the U.S. Food and Drug Administration (FDA) to seek guidance on communication regarding off-label uses.

  • Turning a blind eye.  // Nature Medicine;Jan2008, Vol. 14 Issue 1, p1 

    The author reflects on the proposal for the promotion of off-label medical indications of drugs through the distribution of medical publications in the U.S. He stresses that the U.S. Food and Drug Administration disowns its advisory duty to the medical society and the public if it continues to...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics