The Food and Drug Administration (FDA) said that they want the makers of the antihistamine and anti-nausea drug, promethazine, to give a stronger warning to the consumers to make them aware of the risk involved by the incorrect administration of this drug. It can lead to injuries of the tissue and also gangrene if the injectable drug is administered incorrectly.
FDA now wants a written warning on the label of the drug clearly mentioning the risk and also instructing the drug to not be administered in an artery or under the skin.
Another risk needs to be stated too - a risk that the drug may leach out of the vein during intravenous administration and cause serious damage to the nearby tissue.
The right way of administering the drug is to be injected deep into the muscle.
Apart from the request of a warning on the label it is proposed that if health professionals want to administer promethazine intravenously, the concentration and rate of administration should be limited.
All companies making this drug are required to submit the safety label changes to the FDA within a span of 30 days or provide an explanation regarding their resistance to this change.
The earlier name of promethazine was Phenergan, developed by Wyeth, which is no longer formulated. A lot many other drug developers are now making injectable drug.
This drug came to the market for the first time in 1956 and warnings have been stated previously for tissue injuries, though they have never been required to be included in the box warning.
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