Cold Medicine For Children Under 2 Banned by FDA

A few years ago an infant inexplicably died in an Indiana day care setting .A woman was actually prosecuted for child abuse. She reached a plea. An innocedental finding was mentioned by the Doctor performing the autopsy that the baby had been given cold medication that morning. Behind the scenes, there was speculation that cold medicine could cause death in an infant but it never became an issue in the case because of the controversial plea agreement which involved no jail time. Now an FDA advisory panel has voted to ban over-the-counter cold products intended for children under the age of 6.

Dr. John Jenkins, director of F.D.A.’s office of new drugs, urges parents to read labels. The panel concluded that there was no proof that the medicines eased cold symptoms in children. More imortantly, they also noted there are rare reports that they have caused serious harm.
This ban could change the way parents cope with their young children's syptoms. A week earlier, major manufacturers agreed to withdraw more than a dozen cold products labeled for use in infants. However, manufacturers plan to fight the new recommendations which suggests a ban up to age 6.
“We believe these products will remain on the market,” said Linda Suydam, president of the Consumer Healthcare Products Association.


“We need to go back and review all these recommendations that we heard today and decide what the path forward might be,” Dr. John Jenkins. The panel voted, 21 to 1, to ban pediatric cold products for use in children under 2; however, the vote to extend the ban for 2- to 5-year-olds was 13 to 9. Dr. Joshua Sharfstein, Baltimore’s commissioner of health said drug makers and the agency should agree to end the marketing of cold medicines for children under 6.


PediaCare, Robitussin and Triaminic, which are made by Johnson & Johnson, Wyeth and Novartis are some of the products in issue. The panel concluded that there is no evidence that over-the-counter pediatric cold medicines have any effect on symptoms.


“I’m not going to name names among my acquaintances. But people do use these medications to make their children get some sleep,” Ms. Celento-Stamateris said. Approximately 800 pediatric cold products are sold in the United States that use one or more of 39 different drugs. Consumers spend around $500 million every year buying nearly 95 million boxes containing 3.8 billion doses of medicine. This is big business. The business just got smaller and needs to be further reduced.

Update 10-24:Speaking of child safety:

A recent Washington University School of Medicine study reported in the Washington post has found that the risk of accidental death or injury to babies from crib bumper pads exceeds their benefits. Findings were based on Consumer Product Safety Commission data from 1985-2005 that showed 27 deaths attributed to suffocation (or strangulation) from bumper pads or their ties. Health Day News, The Washington Post 10/22/2007

Read Article: The Washington Post