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Antihistamine Causes Severe Breathing Problems in Children - Promethazine HCL Should Not Be Used On Children Under Two

April 26th 2006

Antihistamine Causes Severe Breathing Problems in Children - Promethazine HCL Should Not Be Used On Children Under Two - FDA

Promethazine HCL

The Food and Drug Administration (FDA) is warning parents and doctors that medications containing promethazine hydrochloride (HCl) should not be used to treat children under the age of two because of possible breathing problems.  The antihistamine can be found in tablets, syrups, injectables and even suppositories. 

There are reports of breathing problems and even some deaths associated with the drug involving children under the age of two.  The FDA says that parents and caregivers should also be careful and get a doctor’s advice about giving promethazine HCl in any form to children age two and older. 

According to an FDA press release, “the labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.”  The FDA is especially concerned and has alerted healthcare professionals, other caregivers, and patients that the drug is also found in cold and or cough syrups.  


The drug was approved in 1951 and has been used for hay fever, stuffy or runny nose due to allergies.  ABC News reported that the drug has also been sold by Wyeth under the brand name Phenergan as well as in various generic versions.

There have been 22 reports of severe breathing problems associated with the drug in children under the age of two.  The drug can also be used to treat or prevent nausea, vomiting, or motion sickness.  Labels will be changed for all medicines containing romethazine HCl.   

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