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FDA Orders Black Box Warning for Injected Sedative at Center of Supreme Court Case

By September 24, 2009July 23rd, 2019Dangerous Drugs

Nearly seven months after the drug Phenergan was the center of a controversial U.S. Supreme Court ruling, the Food and Drug Administration has required a black box warning for the label of its generic version, promethazine. According to the Associated Press, the agency made the labeling change to warn patients about the possibility of gangrene if the drug is administered improperly — the same issue at the center of the Supreme Court case.
Promethazine, an anti-nausea, anti-vomiting and sedative drug, is administered as an injection deep into muscle tissue. However, if it’s administered to an artery or under the skin instead, it can damage tissues so badly that the cells die, sometimes causing gangrene and amputation of the affected area. According to the FDA’s press release, the new label moves the warning about the possibility of gangrene from the package insert onto the outside of the package itself. It will also caution health care professionals to inject the drug deep into the patient’s muscle, and to give the injection slowly and at low concentrations to prevent promethazine from leaking from the veins into the surrounding tissue, where it can do damage.
The lack of strong warnings on the drug was the center of the Supreme Court case, Wyeth v. Levine. Patient Janet Levine sued drug company Wyeth after an injection of Phenergan caused the amputation of her right arm. She alleged that Wyeth failed to provide sufficient warning about the risk of gangrene. Wyeth argued that its labeling was sufficient because it had been approved by the FDA. The federal law allowing the FDA to regulate drug labeling preempts state law, the drug manufacturer argued, meaning that state juries like the one in Levine’s case should not be able to find that its labels are insufficient. This would have effectively ended nearly all lawsuits against drug manufacturers over this issue. However, the Supreme Court ruled 6-3 for Levine, saying Congress did not intend to preempt state juries when it established the FDA.
As a dangerous prescription drug attorney, I am pleased that the FDA took the next logical step after the Wyeth ruling — confirming the need for a labeling change by ordering the strongest warning available. Tissue death, gangrene and resulting amputation are not common reactions to promethazine — but when they happen, they change the lives of the victims forever. Losing an arm requires victims to relearn how to do nearly everything in life, from eating to dressing to driving. It also takes away careers and livelihoods; Levine, the plaintiff in the Supreme Court case, was a guitarist and pianist before she lost her arm. If it can prevent others from suffering from an irreversible, lifelong disability, this labeling change is worthwhile.

Based in St. Louis and Illinois, the Lowe Law Firm represents people across the United States who were seriously injured after taking a medication they thought they could trust. Our pharmaceutical liability attorneys hold manufacturers responsible for meeting the standards laid out by the law — including the requirement that they warn patients about any safety risks of using a drug properly. A lawsuit cannot reverse the effects of a serious medication injury, but it can help victims deal with the sometimes devastating effects of the injury, including the need for more medical care and the loss of an income if they can no longer work. Our defective prescription drug lawyers also help victims claim financial compensation for their physical pain, emotional distress and any permanent disability or wrongful death.
If you or a loved one was hurt by a medication that was supposed to help, you should talk to the Lowe Law Firm as soon as possible. To set up a free, confidential consultation, please contact us online or call us toll-free at 1-877-678-3400.