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Originally published April 19 2009

FDA Conspires with Cold Medicine Manufacturers to Keep Selling Dangerous Products to Four Year Olds

by David Gutierrez, staff writer

(NaturalNews) The FDA admits that it negotiated a deal with pharmaceutical companies to recommend that over-the-counter cold-and-cough medicines should not be given to children under the age of four -- rather than six, as recommended by pediatricians.

"The analysis that led to the under-four cutoff was performed by FDA," agency spokesperson Rita Chappelle said. "We suggested it, and then it was voluntarily adopted by industry. [They] did not come up with the proposal themselves."

Pediatricians had petitioned the FDA to impose a ban on the use of cold-and-cough drugs in children under the age of six, citing lack of scientific evidence that the products work at all in children, as well as a high risk of adverse effects. Advocates of such a measure point to studies finding that 7,000 children in the United States visit emergency rooms every year due to cold-and-cough drug overdoses.

An independent panel commissioned by the FDA to review the doctors' suggestion concluded that the recommendation was sound and should be adopted as a rule by the agency. Instead, the FDA ignored both groups and came up with a new rule.

The agency claims that its conclusions were based on a review of emergency room data on cold-and-cough overdoses in children, but it has refused to release the data it used in its analysis.

"There was no data suggesting that the drugs were effective in kids under 12," objected FDA advisory panel member Sean Hennessy of University of Pennsylvania. "I don't see how [the new policy is] a fully rational approach to the problem."

Baltimore Health Commissioner Joshua Sharfstein, one of the pediatricians who initially asked the FDA for a new rule, agreed that the agency's actions in the case are questionable.

"There is a delicate dance between how much legal authority the FDA has and their use of the bully pulpit for getting some sort of compromise," he said.

The FDA has yet to impose any compulsory regulations regarding cold-and-cough drugs in children.

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