FDA Points Alert to Mitigate Dangers to a Broadly Used Allergy, Nausea Drug

An previous drug with a variety of makes use of now has a brand new FDA alert that would spare sufferers from some extreme reactions.

The FDA communication covers promethazine hydrochloride, a medication accepted for managing allergic reactions, movement illness, and post-operative nausea and vomiting. It’s additionally used as a sedative or as an adjunct to analgesics.

Whereas promethazine is offered in oral formulations, the FDA alert issued Wednesday covers variations administered both as a deep intramuscular injection or as a gradual intravenous injection. The company now says it recommends administration by deep intramuscular injection to cut back the danger of extreme chemical irritation and harm to tissues.

If promethazine should be dosed intravenously, the FDA advises that clinicians observe up to date drug label info stating the drug ought to be diluted and infused via an intravenous catheter inserted in a big vein, ideally via a central venous catheter. The communication particularly states the drug shouldn’t be administered utilizing catheters positioned in to veins within the hand or wrist.

Promethazine’s historical past dates to the Nineteen Forties when it was developed by scientists at Rhone-Poulenc Laboratories, a French chemical firm whose pharmaceutical operations are actually a part of Sanofi. It really works by blocking histamine, a substance the physique produces in an allergic response. The drug’s exercise blocking one other chemical known as acetylcholine led to its use in different indications, equivalent to managing nausea and movement illness. The generic drug is offered within the U.S. as Promethegan and Phenergan, amongst different names.

The FDA alert states that promethazine producers should replace their prescribing info to incorporate the brand new security particulars. The carton labeling and container labels should even be up to date with the corresponding info.

Picture by FDA