New Warning for Phenergan

[Guest guest]

FYI New Warning for Old Drug

The U.S. Food and Drug Administration recently announced new black box

warning labeling changes for promethazine hydrochloride (Phenergan). The new

warnings were prompted by reports of serious adverse events, including

respiratory

depression, apnea, and deaths when promethazine hydrochloride was used in

children under age 2. For other medications that can lead to respiratory

depression, reversal agents are available and effective in an emergency.

Naloxone

(Narcan) is used to reverse the effects of opioids, and the benzodiazepines

can be reversed by flumazenil (Romazicon). Neither of these agents is effective

with Phernergan. Only time and supportive care, which may include mechanical

ventilation, will help the child with respiratory depression associated with

promethazine hydrochloride.

For more info, go to:

_http://www.nursesdrughandbook.com/news/index.cfm?ID=154_

(http://www.nursesdrughandbook.com/news/index.cfm?ID=154)

_www.fda.gov/medwatch/SAFETY/2005/Phenergan_PI.pdf_

(http://www.fda.gov/medwatch/SAFETY/2005/Phenergan_PI.pdf)

I found this information important for persons which children, since someone

may have a young child with pancreatitis and require medication for nausea

and vomiting. Though there are warnings on Phenergan that state, " Not to be

used in children under 2 " , the issue has to do with the use of " age 2 " versus

using a weight guideline, since some children can be over 2 years old, yet

weigh less than a 2 year old. By following these guidelines, they may go ahead

and administer Phenergan to their 2 ½ or 3 year old.

Karyn E. , RN

Executive Director, PAI

www.pancassociation.org