Children’s Sedative May Be Carcinogenic, FDA Told

Food and Drug Administration officials said Monday that they were looking into reports that a drug commonly used to sedate children may cause cancer.

The concerns were raised by California Health Director Kenneth Kizer, who said that, if carcinogenity is confirmed by an Environmental Protection Agency study, the FDA should issue a warning.

In a letter to FDA Commissioner David Kessler last week, Kizer said interim results from the EPA study found cancer in mice that had been given oral chloral hydrate.

“Interviews with health-care professionals who prescribe, dispense and administer chloral hydrate, including neonatologists, pediatricians, pedodontists and hospital pharmacists, indicate that these practitioners are unaware of the carcinogenic risks of this drug,” Kizer wrote.

Kizer sent with his letter brief summaries of more than 20 studies conducted during the 1970s and 1980s involving chloral hydrate. The findings ranged from changes in cell development to genetic mutations. In one study, young mice developed cancer after a single dose.

FDA spokeswoman Eva Kemper said that the agency had received the letter but that “at this point we have no comment.”

EPA officials conducting the study in Cincinnati, Ohio, had left for the day and could not be reached for comment.

Chloral hydrate has been sold for many years as a branded and a generic product for use as a hypnotic and sedative.

It is used by doctors and dentists as a sedative for children to keep them still for examinations. Also, neonatologists give it to newborns on ventilators.