During the 1940s, interest focused on a new class of drugs that could antagonize histamine and be used for the treatment of allergic disorders. The French company Rhône-Poulenc focused their attention on drugs of the phenothiazine class. The two most important products to emerge from this research were the antischizophrenic drug chlorpromazine (Thorazine, Lacgactil) and the antihistamine promethazine (Phenergan), the latter appearing in 1951.
In addition to its antihistaminic properties, Phenergan, like many phenothiazines and other “first-generation” antihistamines, has strong sedative properties. It is available as a nonprescription sleep aid in some countries, including Australia, Canada, and the United Kingdom. Since 1955, it has also been used, by injection, for motion sickness and to control severe nausea and vomiting.
In 2009, Phenergan was the focus of a U.S. Supreme Court decision that has far-reaching ramifications. In the case of Wyeth v. Levine, Vermont bass player Diana Levine received an injection of Phenergan for the treatment of nausea resulting from a severe headache. The drug was inadvertently injected into an artery instead of its intended vein, resulting in tissue damage, gangrene, and the amputation of her lower arm. Because of this potential danger, the Food and Drug Administration and Wyeth, the drug manufacturer, warned against but did not prohibit this “IV push” method of injection. The company argued that since the FDA had approved the drug and the wording on the label regarding its use, Ms. Levine should not be permitted to sue for damages in state court—a legal theory known as FDA Preemption.
IS FDA APPROVAL A LIABILITY SHIELD? In a 6-3 decision, the high court ruled that FDA approval of a medication (including the labeling of that medication) does not shield the manufacturer from liability for any injuries caused by the medication. Understandably, consumer groups and plaintiff attorneys applauded this decision, but pharmaceutical manufacturers derided it.
The prescription cough syrup promethazine + codeine, called “purple drank” and “syrup,” is a recreational drug in the southern United States. Rap stars such as Lil’ Wayne have popularized it in hip-hop song lyrics.
SEE ALSO Codeine (1832), Food and Drug Administration (1906), Benadryl (1946), Chlorpromazine (1952), Dextromethorphan (1958).
An early member of the phenothiazine class of drugs, which includes chlorpromazine, Phenergan is used to prevent and control nausea and vomiting associated with motion sickness. Because it causes marked sedation, however, it is not recommended for use by drivers.