FDA Cautions That These Drugs Should Not Be Given To Children Under Two
On April 25, 2006 the FDA issued a drug safety alert about promethazine hydrochloride, warning doctors and parents that drugs containing promethazine hydrochloride (HCl) should not be given to children younger than two years of age, and they should use care in giving those drugs to children older than two years. The FDA said in this safety alert that seven cases of death and 22 reports of severe breathing problems, all in children younger than two, had been linked to promethazine HCl. The drug, originally approved for use back in 1951, is usually prescribed as an antihistamine or allergy drug.
This April 2006 drug safety alert covers all prescription drugs containing promethazine HCl, and all forms of the drug, including syrups, suppositories, tablets, and injectable liquids. One of the more popular medications containing promethazine HCl is called Phenergan, which is sold by the drug company Wyeth. In addition, there are various generic versions of promethazine HCl available in the U.S.
Safety concerns about Phenergan and other drugs containing promethazine HCl -- while getting renewed interest by means of this April 2006 FDA warning -- have been around for some time. An article by Bloomberg News Service that was published in the Asbury Park Press newspaper on June 23, 2005 provides some background on this issue:
The Food and Drug Administration received 125 reports of adverse reactions in children under age 16 from 1969 through 2003, according to an agency letter that appears in today's 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.
The agency added a warning, enclosed by a black box, to the label last year to alert doctors to problems with the drug known chemically as promethazine. The agency detailed the case for its action in today's journal because of fears that doctors might not notice the change on the label of the decades-old drug, said Badrul A. Chowdhury, director of the FDA's division of pulmonary and allergy drug products.
Phenergan, at least, has never been approved by the FDA for use in children under the age of two.
(Posted by: Tom Lamb)