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Home Wellness Research Childhood Wellness Articles Cold and Cough Over-the-Counter Drugs for Children Found to Be Unsafe, Unproven and Ineffective

Cold and Cough Over-the-Counter Drugs for Children Found to Be Unsafe, Unproven and Ineffective

Saturday, 01 December 2007 00:00

Cold and cough meds given to infants and toddlers work no better than dummy pills and can be dangerous.

Pediatricians made recommendations to the FDA that the overthe- counter meds shouldn’t be given to children younger than 6 years because they don’t help them and aren’t safe. The group petitioned the FDA seeking in part a government statement saying the meds shouldn’t be used in older children, as well. While the focus of the petition and the FDA is on children younger than 6 years, the joint panel of experts will be asked if there’s evidence that these drugs work in children up to age 12 years.

With drug companies spending $50 million a year on emotional ads in parenting magazines and elsewhere, this business has truly become a profitable one for Big Pharma. This is in spite of the fact that there are little or no data from studies in the very young to show the medicines are safe or even work. “The basic question is, why should a product be so relentlessly marketed when it’s not safe or effective?” said Dr. Joshua Sharfstein, Baltimore’s health commissioner. “It does not make sense, in the absence of information, to say ‘consult a physician,’ because they do not have superhuman powers. They cannot make a product safe or effective.”

Even more appalling is that some studies suggest the medicines are no better than dummy pills in treating cold and cough symptoms in young children, the petitioners said.

The drug industry still maintains these widely used drugs are safe and work, but can lead to death and injury from overdoses or misuse in infants. It estimates children receive 3.8 billion doses of the medicines a year.

FDA gave drug companies until Oct. 31, 2007 to stop making and selling any unapproved prescription medicines labeled for use by children younger than 6 years that contain the painkiller and cough suppressant hydrocodone.

The move is part of a broader effort to remove from sale an estimated 200 unapproved prescription cough medicines made with the narcotic.

Manufacturers of any other unapproved hydrocodone medicines, beyond those intended for young children, must stop making them by Dec. 31 and cease shipping them by March 31, 2008, the FDA said. It said the order applies to most of the hydrocodone formulations sold as cough medicines.

The order does not apply to other hydrocodone formulations, including the seven cough suppressants made with the narcotic that do have FDA approval. Nor does it apply to pain-relief drugs like Vicodin, which combine hydrocodone and acetaminophen.

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Pathways Issue 16 CoverThis article appeared in Pathways to Family Wellness magazine, Issue #16.

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