Navigation Links
Off-label drug use common, but patients may not know they're taking them, Mayo finds
Date:8/6/2012

Aug. 6, 2012

ROCHESTER, Minn. -- Many people have probably heard of off-label drug use, but they may not know when that applies to prescriptions they are taking, a Mayo Clinic analysis found. Off-label drug use occurs when a physician prescribes medication to treat a condition before that use has been approved by the Food and Drug Administration. In a newly published article in Mayo Clinic Proceedings, researchers pose and answer 10 questions about off-label drug use.

"Since the Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common," says lead author Christopher Wittich, M.D., internal medicine physician at Mayo Clinic. "Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one."

Some highlights from the article:

  • Off-label drug use is common. Within a group of commonly used medications, roughly 1 in 5 prescriptions were for an off-label use, a 2006 report found. Another study found that about 79 percent of children discharged from pediatric hospitals were taking at least one off-label medication.
  • Patients may not know when drugs they have been prescribed are being used off-label. No court decision has required that physicians must disclose, through informed consent, the off-label use of a drug, the authors say. The FDA makes clear that it doesn't regulate the practice of medicine and that the federal Food, Drug, and Cosmetic Act of 1938 doesn't make physicians liable for off-label drug use, they note.
  • Off-label drug use can become the predominant treatment for a condition. For example, some antidepressants are not approved by the FDA as a treatment for neuropathic pain, yet some drugs in this class are considered a first-line treatment option.
  • Examples of widely practiced off-label drug use include morphine, used extensively to treat pain in hospitalized pediatric patients. Many inhaled bronchodilators, antimicrobials, anticonvulsants, and proton pump inhibitors also are used in children without formal FDA approval.
  • Obtaining new FDA approval for a medication can be costly and time-consuming. To add additional indications for an already approved medication requires a supplemental drug application; if eventually approved, revenue from it may not offset the expense and effort for obtaining approval.
  • Generic medications may not have the requisite funding resources needed to pursue FDA-approval studies. For these financial reasons, drug proprietors may never seek FDA approval for a new drug indication.
  • Pharmaceutical manufacturers are not allowed to promote off-label uses of medications. However, they can respond to unsolicited questions from health care providers and distribute peer-reviewed publications about off-label use. Just this year, GlaxoSmithKline agreed to pay a record $3 billion to settle a Justice Department case involving alleged off-label drug use marketing, and Merck Sharp & Dohme was fined $322 million over its alleged promotion of the painkiller Vioxx for an off-label use.


'/>"/>

Contact: Nick Hanson
newsbureau@mayo.edu
507-284-5005
Mayo Clinic
Source:Eurekalert

Related medicine news :

1. Off-Label Drug Use Appears Common
2. Reducing off-label use of antipsychotic medications may save money
3. Texting in College Classrooms Common, Distracting
4. Higher-spending hospitals have fewer deaths for emergency patients
5. Researchers uncover a viable way for colorectal cancer patients to overcome drug resistance
6. Vaccine yielded encouraging long-term survival rates in certain patients with NSCLC
7. Study finds doctors have exaggerated fears when starting patients on insulin
8. Diagnostic Scans Tied to Radiation Risk for Gastro Patients
9. Predictors identified for rehospitalization among post-acute stroke patients
10. Pulse pressure elevation could presage cerebrovascular disease in Alzheimers patients
11. Breast cancer patients suffer treatment-related side effects long after completing care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/29/2017)... ... March 29, 2017 , ... The Professional ... it has enlisted New York City-based sports and entertainment marketing firm Leverage Agency ... sponsorship opportunities for the Professional Squash Association (PSA), which includes first-time ever title ...
(Date:3/29/2017)... ... 2017 , ... CHARM CITY RUN WELCOMES MERCY MEDICAL CENTER AS , BALTIMORE ... will serve as the official title sponsor of the Baltimore Women’s Classic, the largest ... of women will walk or run the course around the Baltimore Inner Harbor. Mercy ...
(Date:3/29/2017)... ... 30, 2017 , ... Sports Brand EXOUS Bodygear announced today a special sale ... for the remaining days of March, the price will be only $19.97. The EXOUS ... of just $10 (regular retail price $19.97). , The special promotional prices are to ...
(Date:3/29/2017)... , ... March 29, 2017 , ... ... with or without a referral to new patients from Burnaby, BC. Patients in ... other full mouth reconstruction services, can see the esteemed team at Wall Centre ...
(Date:3/29/2017)... ... March 29, 2017 , ... Dr. Angela Cotey, a noted general dentist in ... pediatric patients, with or without a referral. Dr. Cotey knows that interceptive orthodontics ... and experience. When patients receive early treatment, they may achieve straight teeth with less ...
Breaking Medicine News(10 mins):
(Date:3/29/2017)... 2017 Global intravenous (IV) iron and oral iron ... growing at a CAGR of 5%. Iron ... to treat anemia or other iron deficiencies. Oral iron supplements ... However, in some cases, oral administrations are not capable of ... iron therapy comes into the picture. Global Intravenous ...
(Date:3/29/2017)... DES MOINES, Iowa , March 29, 2017 ... Iowa Lt. Gov. Kim Reynolds , Department of Public ... Control Policy Director Steve Lukan in announcing the ... at all CVS Pharmacy locations in Iowa.  CVS Health has ... that allows CVS Pharmacy to expand access to ...
(Date:3/29/2017)... March 29, 2017  Experts in the field ... devices like  Soberlink Systems  as a model for ... published in early 2017, concluded that remote blood ... managing patient recovery." The findings of ... Addiction Medicine, detail a range of variables that ...
Breaking Medicine Technology: