The Food and Drug Administration (FDA) is recommending that over-the-counter cough and cold medications be banned for children under 6.
The reviewing panel concluded that there was no evidence these products work, and, in fact, they may actually cause harm to young children.
The lack of scientific evidence of the products’ efficacy, and the fact that children can overdose when products are given in combination, and too often, resulted in the ban recommendation.
The product manufacturers will fight the proposed ban, which is likely to take years to implement. The Consumer Healthcare Products Assocation, the trade group for the manufactuers, believes the products should stay on the market, that they are safe when used as directed, and that they will continue to be safe if parents are educated on correct use. They urged further studies to back up their claims.
But the FDA panel rejected claims that the products work. “Saying that they should still be used in the absence of efficacy data, knowing that they cause risks, would be irresponsible,” panel member Sean P. Hennessy of the Univerity of Pennsylvania Medical School was quoted in The New York Times. And Dr. Joshua Sharfstein, the Commissioner of Health in Baltimore and co-author of the petition which led to the FDA review, was also quoted as saying: “After the advisory committee’s clear vote, there is no justification for formulations of these products geared at toddlers or depicting small children.”
The panel did vote to allow the continmued marketing of OTC cough and cold products for children 6 and older, but strongly advised that the measuring cups that come with the products be standardized across the industry, in order to cut down the risk of accidental overdosing.
And they voted to ban the use of the term “doctor recommended” on pediatric cough and cold packaging.
The pediatric products came onto the market in the 1970s, without the backup of study data. They had been approved for adults and it was believed then that what works for adults would also work with children. Since then, this theory has been debunked across many product lines with studies pointing to children’s very different body size and metabolism.
The American College of Chest Physicians and the American Academy of Pediatrics supports the FDA’s proposed ban.
The Centers for Disease Control and Prevention (CDC) has found that between 2004 and 2005, more than 1,500 children under age 2 suffered serious health problems after taking common cough and cold medications.
The Times also reported that, additionally, the FDA has warned the makers of nearly 200 unapproved prescription medicines containing hydrocodone that they must stop making these products for children under age 6. The FDA has approved seven prescription cough medications containing hydrocodone but another 200 are available to doctors. Hydrocodone is a powerful and potentially addictive narcotic.
Makers of such children’s products have until October 31 to get them off the shelves; makers of the adult versions have until December 31.
IMPORTANT GUIDELINES FOR PARENTS
The FDA has issued these current guidelines on cough and cold medications:
—Do not give cough and cold products to children under 2 years old unless specifically directed to do so by a healthcare provider.
—Do not give children medicine that's made for adults. Only use products marked for babies, infants or children, which are sometimes labeled as "pediatric". Caregivers should be sure to read the "Drug Facts" box on the label to understand how to use the product and know the active ingredients and warnings.
—Do not give your child other prescription or non-prescription medicines at the same time as cough and cold medicines without first checking with your child's healthcare provider.
—Do not use kitchen utensils like a teaspoon or tablespoon to measure out liquid medicines. Instead, use the dropper, dosing cup or dosing spoon that comes with the medicine. If a measuring device is not included, buy one at a pharmacy and be sure it has markings that match the dosing recommendations on the drug label or given by your child's healthcare provider.