Phenergan Gets Black Box Warning from the FDA
Posted by
Camryn HansenSeptember 21, 2009 8:09 PM
One woman’s horrific experience with Phenergan, the migraine drug formerly sold by Wyeth, has finally ended in a black box label—the strongest warning offered by the FDA—on the drug.
When in April of 2000, violinist Diana Levine went to her local health center seeking migraine treatment, a physician’s assistant administered Phenergan intravenously via the IV push method. But because the syringe missed Levine’s vein, the arm became gangrenous in a couple of weeks, and ultimately had to be amputated.
Levine sued Wyeth in Vermont State court, but the case was taken all the way to the US Supreme Court. Ultimately, the question the Court had to decide was whether or not Wyeth should be liable for Levine’s gangrene and subsequent arm amputation because the company knew of the risks of gangrene from the IV push method (more than 50 patients have developed gangrene as a result of using this specific method with Phenergan), and nevertheless marketed the drug to be used this way.
The Supreme Court sided with Levine, rejecting Wyeth’s arguments in favor of federal preemption and awarding the plaintiff $6.7 million in damages. Until last week, however, the FDA didn’t respond by placing any more regulations on Phenergan, also known as promethazine.
Now, promethazine will carry a black box label warning physicians that the safest way to administer the drug is through intramuscular injection (not IV push).
While it would have been gratifying to see the FDA ban the IV push method altogether with this drug, as Levine has indicated herself, the black box warning is nevertheless a win for consumer protections.