FDA Orders Stronger Warning on Injectable Promethazine Hydrochloride (Phenergan)
The sedative drug promethazine must include stronger warnings on the product’s packaging to warn medical professionals and patients about the risks of serious tissue injury when the injectable form of the drug is improperly administered, the Food and Drug Administration said.
The drug, which was sold under the brand name Phenergan made by Wyeth Pharmaceuticals Inc. before it was discontinued, is approved for use as a sedative and to treat nausea and vomiting. While Phenergan is no longer in circulation, various generic forms of injectable promethazine still are produced and used.
Promethazine was approved in 1956 and has been associated with several cases of gangrene requiring limb amputation caused by improper administration of the drug, the FDA said.
Warning of Incorrect Administration Risks
The FDA is warning about the risks of gangrene and other severe tissue damage when the drug is injected directly into an artery or under the skin. Another risk is the drug leaching out from the vein during intravenous administration, which can cause serious damage to surrounding tissue. Therefore, the preferred method of administering promethazine is injecting the drug deep into muscle, the FDA warning said.
If promethazine is administered intravenously, the drug’s concentration and the rate of administration should be limited and carefully monitored to ensure a properly functioning intravenous line, the FDA advised.
Wyeth and other companies that produce forms of promethazine must submit safety label changes to the FDA within 30 days or provide a valid reason why they believe the labeling revisions are not necessary.
Earlier Warnings Issued
This is not the first time the FDA has warned about the risks of improperly administering promethazine. In December 2006 and February 2008, the agency issued similar warnings to consumers and healthcare professionals describing the risks of serious tissue injury, including gangrene, if the drug was inadvertently administered into an artery. However, the FDA has not until now required a boxed warning about the risks to be included on the drug’s packaging.
Phenergan at Center of Landmark Legal Case
Phenergan was the drug at the center of a landmark U.S. Supreme Court case in 2008 that held Wyeth and drug companies are not immune from personal injury lawsuits filed for injuries caused by their products. Wyeth had argued that since Phenergan’s labeling had been reviewed and approved by the FDA, the company was exempt from such lawsuits brought in state courts.
The lawsuit was brought by Diana Levine, a guitarist who lost part of an arm due to gangrene after she was given Phenergan for a migraine headache. Levine sued Wyeth and contented that the company had not sufficiently warned about the risks of improperly administering the drug, causing her an injury.
The Supreme Court upheld the $6.7 million jury award to Levine and held that FDA approvals of a drug’s labeling do not preempt state laws or shield drug companies for liability lawsuits brought by injured patients.
The FDA is now ordering makers of promethazine to warn of the risks of administering the drug in precisely the same way that caused Levine’s devastating injury.
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