A group of doctors and consumer advocates raised the specter of ineffective and even dangerous cough and cold meds for youngsters between the ages of 2 and 6 years old as justification for an all-out ban at an FDA meeting today. Last year, in fact, an FDA advisory committee recommended the same thing for this group of over-the-counter meds.

“Cough and cold medications…have not been proven to be effective and they have clear risks. It is time for them to be reevaluated,” Wayne Snodgrass of the University of Texas Medical Branch, told the gathering, according to Reuters. Parents want their children to feel better, but “it is too easy to administer too much or not enough,” added Mimi Johnson, a health policy associate at the National Consumers League.

Among the meds - Novartis’s Triaminic; Johnson & Johnson’s Tylenol and PediaCare; Wyeth’s Dimetapp and Procter & Gamble’s NyQuil. All totaled, this group generated $3.6 billion in sales last year. Although sold for decades, the meds may increase the risk of hallucinations, stroke and seizures, among other things, often because of dosing errors. They also have never been proven to work, some docs say.

Last January, the FDA issued a public health advisory that the drugs should not be given to children younger than 2 years old. Today’s hearing was designed to consider several questions: What types of studies should be done to evaluate the drugs? Should they remain available without a prescription? How should doses be determined? Should drugs combining different ingredients remain available?

The drugs were allowed on the market under rules for over-the-counter products that do not require data showing safety and efficacy. Instead, data were extrapolated from adults. And industry reps rejected concerns, saying the meds are safe for children over 2 years old when used as directed.

Most reported problems occur when kids accidentally ingest the meds or are given the wrong dose, according to Linda Suydam, who heads the Consumer Healthcare Products Association. “There really isn’t a safety problem,” she told the gathering, adding that drugmakers are launching several studies to look at individual ingredients, educating parents and changing packing to improve proper dosing.

Intense marketing is part of the issue, Reuters notes. The meds are made to taste good, have packaging with pictures of cute animals and fruit, and ads portray doctors touting the products, which range from pills and syrups to rubs and nasal sprays, advocates told the FDA.

In resonse, CHPA’s Suydam says drugmakers already agreed to remove claims that meds are recommended by pediatricians from packaging and ads. “I don’t think simply marketing them encourages parents to use them,” she added. Without the children’s versions, she continued, parents could simply turn to stronger adult formulations or potentially risky alternatives.

For their part, FDA planned to issue an opinion on children ages 2 to 6 earlier this year, but in August asked for more info and announced a public meeting. John Jenkins, director of the FDA’s Office of New Drugs, says the agency will propose changing its rules but did not say when those changes would be made public.

New rules could further restrict use of the products in children, a process that could take years, or require them to go through a new approval process requiring clinical trials. Officials also could issue further parent recommendations, Reuters points out.

“The needless delay by the FDA and the continued sale of these products might be acceptable if new scientific data undermining the advisory committees’ conclusions had been generated,” Public Citizen’s Peter Lurie argued in his testimony. “But, in fact, the few new studies published in the past year support the committee’s general conclusions concerning lack of efficacy and safety problems.

“With each passing month we see more unnecessary cases of child poisoning from these products and millions more parents squandering their earnings on these ineffective medications. The FDA should set and adhere to a strict time table for its actions.”

Source: Reuters