FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

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FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

fda.gov

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.

View full resource at fda.gov

Tags: Nausea, Vomiting, Nausea and Vomiting Medication, Drug, Healthcare, FDA, Phenergan, Pentazine

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Most Recently Shared on September 17, 2009 at 4:36 pm By:

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FDA Requires Boxed Warning for Promethazine Hydrochloride Injection: http://bit.ly/Fwp4s

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FDA Alert: Promethazine Hydrochloride Injection

drugs.com — “FDA Alert: Promethazine Hydrochloride InjectionView full resource at drugs.com

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Promethazine Hydrochloride Injection

fda.gov — “Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine.View full resource at fda.gov

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empr.com — “The FDA has 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.View full resource at empr.com

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