Deaths of 7 Children Lead to Antihistamine Warning

Wyeth’s antihistamine Phenergan and generic versions of the drug led to the deaths of seven children under age 2 in the last 35 years, leading U.S. regulators to restrict its use, according to a study published today.

The Food and Drug Administration received 125 reports of adverse reactions in children under 16 from 1969 through 2003, according to an agency letter in today’s issue of the New England Journal of Medicine. Problems included 38 cases of respiratory distress and cardiac arrest, 29 cases of involuntary muscle contractions and 15 seizures. Infants had the greatest risk.

Known chemically as promethazine, it is used to treat allergies as well as reduce nausea and sedate patients.

The agency detailed the case for its action because of fears that doctors might not notice a warning added last year to the label of the decades-old drug, said Badrul A. Chowdhury, director of the FDA’s division of pulmonary and allergy drug products.

Phenergan has never been approved for children under 2, Wyeth spokesman Chris Garland said. “If the FDA’s rationale for writing the letter was to raise awareness, we completely agree with that,” he said.

Shares in Madison, N.J.-based Wyeth fell 38 cents Wednesday to $43.50.