FDA Openly Allowed Marketing of Dangerous Cold Medicines to Infants and Children

Monday, April 14, 2008 by: David Gutierrez, staff writer
Tags: cold medicines, children's health, health news

(NaturalNews) An FDA advisory panel has recommended a ban on the marketing of cold medication to children younger than 6 years old, following a recommendation from the American Academy of Pediatrics. There have been no studies conducted to see if the medications are even effective on that age group, and evidence is mounting that they may be dangerous.

Current FDA guidelines, set in place in the 1970s, allow dosage and effectiveness data on adults to be extrapolated to children merely by reducing the dose 50 to 75 percent. But many doctors say that there is no scientific basis for such an assumption, since children often react very differently to medication than adults.

Pharmaceutical companies recently decided to voluntarily withdraw 14 different infant cold medicines after doctors, politicians and government regulators raised concerns about their safety. According to the FDA, the agency knows of 54 decongestant-related deaths in children and 69 deaths linked to antihistamines between 1969 and 2004.

"If so many experts are advising against these medicines for children, then why are they so widely used?'' said Joshua Sharfstein, Health Commissioner for the city of Baltimore. "There's a gap in federal oversight. FDA has permitted widespread marketing that's not supported by the scientific evidence.''

Members of the FDA advisory panel have suggested conducting large-scale clinical trials of the drugs on children to see if they are safe.

According the FDA, there are more than 800 cold-related over-the-counter medications on the market, and the revenue for sales of these products to children alone amounted to $3.8 billion in 2006. Doctors, however, say that fluids, moist air and saline drops are the best way to treat colds in children.

"Cold medicines for infants and children are pure quackery," says consumer health advocate Mike Adams. "They are Big Pharma's snake oil. There is zero scientific evidence showing cold medicines are either safe or effective when used on infants and children. The aggressive marketing of these over-the-counter medicines, packaged as infant or baby medicines, is dishonest, unethical and is no doubt causing far more harm than good," said Adams.

In response to the call for a marketing ban, one drug industry trade group -- the Consumer Healthcare Products Association -- responded that such regulations are unnecessary, instead suggesting that drug companies add warnings to pediatric cold medicines. Among the suggested labels are, "Do not use in children under 2," and "Do not use to sedate children."