Kid Coughing

Today the FDA is holding a hearing on over-the-counter cough medicines marketed for use in children under 6. Our colleagues at the Prescription Project have issued a new report, Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children. The reports documents that the industry spends more than $50 million a year marketing cough medicines for children under 6, despite the lack of evidence that such drugs are effective for such children, and evidence that the drugs can present serious risks. See coverage of this issue, and of the industry’s recent preemptive recall of a number of these medications approved for use in children 2 and under, here.

We here at the Prescription Access Litigation blog often lament the explosion of advertising for prescription drugs. But the huge spending on marketing of Over-the-Counter remedies is also troublesome. Over-the-Counter remedies are supposed to be safe enough for patients to take without a physician’s supervision. The disclosures that Over-the-Counter drugs have to make are, thus, much less than for prescription drugs. This lulls people into a false sense of security that if a drug is Over-the-Counter, it must be completely safe. Widespread marketing of these drugs only increases that impression. And marketing such drugs for use in children uses this belief to offer harried parents a quick fix for their children’s symptoms.

At the root of many of the problems caused by drug advertising, whether prescription or over-the-counter, is the shift in recent decades to thinking about medicines not as medical treatment but as a consumer product. But as we here are fond of saying — drugs are not like fabric softener or shampoo, and we treat like as such at our peril.

The FDA recently announced that it will hold a hearing on November 14, to consider whether to make certain drugs available only “behind the counter” — that is, without a prescription but only dispensed by a pharmacist. Presumably, this would introduce the intervention and consultation of a pharmacist, who could ask the patient questions to determine if the drug was really appropriate and advise them of alternatives if it was not. Many other countries have numerous drugs “behind the counter” that are Over-the-Counter in U.S. While we here at PAL don’t have a position on this proposed new status for drugs, it does seem that these cough medicines would be a good candidate if this status were created.

Below is the Prescription Project’s press release on the report, which you can find here.

The Prescription Project Report Shows Industry Spends $50 Million-a-Year Marketing Cough and Cold Medicines for Children Despite Evidence of Risks

Report says lack of results, risks for children under six does not deter drug company marketing of these products as “safe and effective.”

BOSTON–(BUSINESS WIRE)–The Prescription Project today released a report showing that companies producing over-the-counter (OTC) cough and cold medicines spent more than $50 million marketing these widely used products for children under the age of 6 despite evidence of risks and lack of effectiveness in treating children. The report, titled Risk With No Benefit: The Marketing of Over-the-Counter Cough and Cold Medications for Children, was released to coincide with today’s Federal Drug Administration’s Nonprescription Drug Advisory Committee hearing on the potential dangers of these products for children under the age of 6.

The Prescription Project report, which analyzed FDA, industry, and epidemiological documents on OTC remedies, shows a lack of efficacy data but a significant number of reported injuries and deaths associated with overdosing of these products. Manufacturers have heavily marketed this class of OTC preparations for many years based on their FDA classification as “safe and effective,” yet the FDA has not conducted or brought forward a single study or review to prove the safety or effectiveness of these products for use in small children in the last three decades. The full report is available at

“Especially when it comes to over-the-counter drugs, physicians and patients rely on the FDA to ‘calculate’ the benefits versus risks and communicate this to the public,” said John Santa, MD, MPH, a consultant to the Prescription Project and former medical director of the Drug Effectiveness Review Project (DERP). “In this case, it appears the benefits are close to zero while the risks are significant.”

Last week, in response to growing questions and pressure from pediatricians and the FDA, major manufacturers of the popular cold remedies announced that they were voluntarily withdrawing from the shelves OTC infant cold and cough products marketed for children age 2 and under. As of yet, there has been no action on drugs marketed for children 2-6 years old.

About The Prescription Project

The Prescription Project is led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Created with The Pew Charitable Trusts, the Project promotes evidence-based prescribing and seeks to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians by working with academic medical centers, professional medical societies, public and private payers, and state and federal policymakers. For more information, please visit