Navigation Links
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
Date:9/16/2009

WASHINGTON, Sept. 16 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA's authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, the boxed warning says. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.

A requested revision in the Dosage and Administration section of the label states that if health care professionals choose to administer promethazine intravenously, they should limit the drug's concentration and rate of administration and ensure a properly functioning intravenous line.

The companies that make promethazine are required to submit the requested safety label changes to the FDA within 30 days or provide a reason why they do not believe such changes are necessary. If they do not submit new language, or the FDA disagrees with the language proposed by the companies, the agency can order the label change as deemed appropriate to address the new safety information.

Promethazine was previously sold under the brand name Phenergan, but that formulation was discontinued by Wyeth Pharmaceuticals Inc. A number of companies currently market generic formulations of promethazine hydrochloride injection.

The FDA previously informed consumers and health care professionals about the risks of incorrect administration of promethazine in the December 2006 and February 2008 editions of FDA Patient Safety News. Current prescribing information for the drug contains information about the risk of tissue injury, possibly including gangrene, if the drug is inadvertently administered in the artery, but that information was not highlighted in a boxed warning.

Promethazine first went on the market in 1956. FDA has reviewed the published literature and post-marketing adverse event reports submitted to the agency's Adverse Event Reporting System from 1969 to 2009 and identified cases of gangrene requiring amputation associated with administration of the drug.

More information is available in this Information for Healthcare Professionals:

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm182169.htm

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. To get college students to wash hands requires proper tools, attention-getting tactics
2. Getting College Students To Wash Hands, Halt Disease, Requires Giving Them Proper Tools and Spreading The Word In Ways That Get Attention, Say K-State Expert and Colleague
3. Eliminating polio requires global, coordinated effort -- Health Affairs article highlights risks, rewards of eradication
4. Neuroimaging suggests that truthfulness requires no act of will for honest people
5. THCA on 2009 Legislative Session: Seniors Medicaid-Financed Nursing Home Care Requires Substantially More Investment as Population Ages, Care Needs Grow
6. When Chest Pain Requires Quick Action in ER
7. Using tools requires that the brain is able to control movements
8. Getting Closer to Controlling Cancer Requires Funding More Laboratories and Commitment Beyond Two Years of New Stimulus, Weiner and Berg Assert in Denver Post Oped
9. Poison Prevention Requires Diligence
10. Recession-resistant Marketing Requires Innovative Steps
11. Stimulus Bill Requires Modification in U.S. Senate to Better Protect Seniors Ongoing Access to Quality Nursing Home Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... ... December 08, 2016 , ... The ... the Undersea and Hyperbaric Medical Society (UHMS), the leading authority in hyperbaric medicine. ... safety. Only a few hospitals and facilities have earned this distinction. This is ...
(Date:12/8/2016)... ... December 08, 2016 , ... Russ ... announced the first national #QuackGivesBack campaign which supported local breast cancer organizations during ... franchise-wide Quack Gives Back initiative, and we’re very pleased with the ...
(Date:12/8/2016)... Pa. (PRWEB) , ... December 08, 2016 , ... ... Medicine Southern Chester County, a Property owned by an affiliate of Seavest, has ... square foot Penn Medicine Southern Chester County ambulatory care center (ACC) was named ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... CURE Media ... centers and advocacy groups, has aligned with Upstage Lung Cancer in efforts to combat ... the announcement, Michael J. Hennessy, Jr said, “CURE Media Group is honored to team ...
(Date:12/8/2016)... ... December 08, 2016 , ... David J. Dykeman , ... Greenberg Traurig, LLP, will speak at DeviceTalks West, Dec. 12, 2016, at the Fairmont ... and attorneys from the firm’s global Life Sciences & Medical Technology Group have been ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... Lilly and Company (NYSE: LLY ) today ... at the 9 th Clinical Trials on Alzheimer,s ... meet the primary endpoint in the EXPEDITION3 clinical trial, ... dementia due to Alzheimer,s disease (AD), and Lilly will ... of mild dementia due to AD. ...
(Date:12/8/2016)... DUBLIN , Dec 8, 2016 Research ... Electrodes Market Analysis and Trends - Adhesion Type, Application, Usability - ... ... The Global Cardiology Electrodes Market is poised to grow at a ... prominent trends that the market is witnessing include advancements in extracellular ...
(Date:12/8/2016)... 8, 2016   TriNetX , the health ... Hospital signed a membership agreement to join ... of new cures. The TriNetX network ... million patients globally, biopharmaceutical companies and contract research ... protocol design, site selection, patient recruitment, and collaborative ...
Breaking Medicine Technology: