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FDA Requires Boxed Warning For Allergy Drug Promethazine

by Gopalan on September 18, 2009 at 10:17 AM
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 FDA Requires Boxed Warning For Allergy Drug Promethazine

The U.S. Food and Drug Administration has directed manufacturers of promethazine hydrochloride injection to include a boxed warning of possible tissue injuries when it is administered incorrectly. Health care professionals are also being alerted to the new boxed warning, the agency said on its website.

Promethazine relieves itchy, red, irritated, watery eyes; runny nose; sneezing; and itchy skin caused by hay fever and allergies. It also is used for motion sickness, before and after surgery as a sedative to relieve apprehension, and to prevent and treat nausea and vomiting.

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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.
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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.



Source: Medindia
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