Safety Alerts & Recalls

What does this mean?

If you are taking the tablet, syrup, or suppository form of promethazine, the new safety warning does not apply to your use of this form of the medicine. However, if you are ever in a situation (hospital, emergency room, doctor's office or clinic) where you are offered injectable promethazine or if you are currently receiving injectable promethazine administered by a visiting nurse or other health care professional, please be aware that injectable promethazine can cause severe skin reactions if administered incorrectly. In order to reduce the risk of serious skin reactions, the preferred method of administration is injecting the drug deep into the muscle.

The FDA is recommending the following to patients who receive the injectable form promethazine:

1) Discuss any concerns you may have about the risks and benefits of promethazine with your health care professional who prescribes or administers the medicine.

2) Pay close attention for any signs or symptoms of adverse events including burning or pain at the injection site, redness, swelling, and blistering, and report these symptoms immediately.

3) Understand that side effects may occur immediately while receiving a promethazine injection or may develop hours to days after an injection.

FDA Requires Black Box Warning for Injection Form of Promethazine

The FDA is requiring the makers of injectable promethazine to add a Black Box Warning explaining that when the drug is administered incorrectly, it can severely damage skin, and may cause gangrene. The FDA is also requiring the prescribing information for injectable promethazine to include recommendations for safe administration which includes injecting the drug deep into the muscle or limiting the drug's concentration and rate of administration if health care professionals choose to give the drug intravenously.

Injectable promethazine (previously sold under the brand name Phenergan) is typically administered in an emergency room, hospital or doctor's office or clinic setting to treat severe nausea and vomiting. This black box warning does not apply to the forms of promethazine that are taken by mouth (tablets, syrup) or administered rectally (suppositories also sold under the name Promethacon and Promethegan).

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Source: FDA
Publication Date: 2009-09-17
Last Updated: 2009-12-05

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