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Industry increases minimum age for cough and cold medicines

It has been almost a year since the FDA dug into the issue of cough and cold medicines being promoted for infants and toddlers. Now the industry has released a voluntary recommendation that they be avoided for children under four. Risks include interactions between ingredients in cough and cold remedies, the risk of overdose, and misuse by parents hoping to help sick children sleep. Pediatricians have been arguing for years that they should be banned for children under six.

As the New York Times reported then:

Most cough and cold concoctions have nasal decongestants, antihistamines, cough suppressants or expectorants — common ingredients with names like dextromethorphan, guaifenesin and phenylephrine. Most of these drugs have been around for decades and were approved for sale by the F.D.A. when standards were far lower than they are today. Medicines were often approved with little or no testing before 1970 to ensure that they were safe or effective. Since then, the agency has gradually tightened standards and occasionally revisits old standards.

The agency has put all the compounds on a "monograph," meaning that manufacturers can use and combine them in pills and syrups without doing any of the expensive and lengthy studies that would be needed for a new drug. Because the drugs are so widely available, there is no incentive for manufacturers to perform such studies. Information about their lack of efficacy and worrisome side effects have trickled out.


Make no mistake: These medications are potentially dangerous to young children, and they provide no clear benefit to children.
Categories: illness, medicine
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