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Chris Cavanaugh
FINALLY THE FDA ADDRESSES THE RISKS WITH PHENERGAN
MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

 


Promethazine Hydrochloride Injection

Audience: All healthcare professionals

FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.

Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering.

Read the complete MedWatch 2009 Safety summary including links to the Information for Healthcare Professionals sheet and News Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182500.htm

 


lynncrni
So glad Chris posted this. It

So glad Chris posted this. It is a welcome addition to our evidence for the dangers of this drug. I know this was discussed by at least 2 presenters at this weeks AVA conference. I do not wish to see another legal case with a horrible outcome from this drug! Lynn

Lynn Hadaway, M.Ed., RN, BC, CRNI

Lynn Hadaway Associates, Inc.

126 Main Street, PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

momdogz
hurrah!

Thanks for posting, Chris.

Mari Cordes, BS RNIII VA-BC
Vascular Access Department
University of Vermont Medical Center

daylily
Who has removed the IV route?

Last year my attempts failed to get this removed from formulary.  Now that the black box warning has come out I think it "may" generate change.  The CNO is asking what other facilities are doing.  So I ask, who has removed the drug from formulary, who has removed the IV route and who has diluted in 50ml or other method to reduce the risk of injury.  I need the name of your facility.

tbaugher
Phenergan

I work in the WellStar Health System in Atlanta, we removed phenergan from our formulary 2 months ago. In my opinion, the best customer service initiative ever! Terri Baugher

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