Navigation Links
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

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.


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:

Media Inquiries: Karen Riley, 301-796-4674;

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:
(Date:12/1/2015)... ... ... Royal River Natural Foods — a locally-owned, independent natural health store in ... nutritional supplement creatine, along with resistance training for a year, had more new bone ... report is part of the December 2015 issue of Natural Insights for Well Being®, ...
(Date:12/1/2015)... ... December 01, 2015 , ... According to an article ... filed a discrimination claim against the U.S. Department of Health and Human Services, claiming ... Act (ACA) plans are breaking the clause in the law prohibiting the denial of ...
(Date:12/1/2015)... ... December 01, 2015 , ... Califia Farms , one of ... iconic bottle has won top honors in Beverage World Magazine’s Global Packaging Design Awards, ... that it has been selected as a 2015 U.S.A. Taste Champion in the American ...
(Date:12/1/2015)... ... ... Growth in medical payments per workers’ compensation claim in Louisiana slowed from ... care, according to a recent study by the Workers Compensation Research Institute (WCRI). ... payments per claim with more than seven days of lost time continued to be ...
(Date:12/1/2015)... ... December 01, 2015 , ... CloudLIMS ... 2015 Golden Bridge Business Awards under the New Products and Services category for ... based sample management software that helps labs organize data and track ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... Va. , Dec. 1, 2015 As ... Drug Supply Chain Security Act (DSCSA) approaches, ... small and independent pharmacies comply with looming FDA ... InfiniTrak is entering endorsement agreements with State ... pharmacy services administration organization (PSAO) to exclusively provide ...
(Date:12/1/2015)... 2015  CytoSorbents Corporation (NASDAQ: CTSO ), ... blood purification technology to reduce deadly uncontrolled inflammation ... that Dr. Phillip Chan , President & ... the LD Micro Main Event 2015 and the ... which will be held in December. ...
(Date:12/1/2015)... A federal court has denied the state of ... filed by the Pharmaceutical Care Management Association (PCMA) challenging the ... law that forces employers and consumers to pay drugstores higher ... must now defend a law that raises health care ... Mark Merritt . --> Arkansas ...
Breaking Medicine Technology: