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 -- The Prescription Project today released a report showing that companies producing over-the-counter (OTC OTC See: Over-the-counter. OTC See over-the-counter market (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 non·pre·scrip·tion adj. Sold legally without a physician's prescription; over-the-counter. 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , 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 www.prescriptionproject.org. "Especially when it comes to over-the-counter drugs over-the-counter drug A therapeutic agent that does not require a prescription, which the FDA feels can be safely self-prescribed by non-physicians. Cf Prescription drug, Under-the-counter. , physicians and patients rely on the FDA to 'calculate' the benefits versus risks and communicate this to the public," said John Santa John Santa Mr. Santa is an award winning audio and video producer who lives in Chapel Hill, NC. An accomplished musician, Mr. Santa was the front man of The John Santa Band in the mid 1970s. Mr. , MD, MPH, a consultant to the Prescription Project and former medical director of the Drug Effectiveness Review Project The Drug Effectiveness Review Project (DERP) is an Oregon-based collaboration of public and private organizations, including fifteen states, that have joined together to provide systematic evidence-based reviews of the comparative effectiveness and safety of drugs in many widely (DERP DERP Defense Environmental Restoration Program DERP Drug Effectiveness Review Project DERP Defective Equipment Replacement Program DERP Design Eye Reference Point (aviation) DERP Disposable Eye-Respiratory Protection ). "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 Pew Charitable Trusts, philanthropic foundation established (1948) by the children of Sun Oil Company founder Joseph N. Pew (1886–1963) of Philadelphia to provide funds for "general religious, charitable, scientific, literary, and educational purposes. , 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 www.prescriptionproject.org. |
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