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Feds to Toughen Rules for Over-the-Counter Kids' Cold Medicines

A bitter pill for drug companies

By Mark Huffman
ConsumerAffairs.com

August 24, 2008

• Kids Cough Medicine Gets Warning Labels; Critics Not Impressed • Parents Urged To Shun OTC Cough Medicine • Children and Prescription Drug Abuse: The Threat at Home • Feds to Toughen Rules for Over-the-Counter Kids' Cold Medicines • Children Still Taking Dangerous OTC Medicine, Study Finds • Study: Children Should Not Take Antihistamines for Chronic Cough • More Bad News about Cough Medicine • Saline Nasal Wash Improves Children's Cold Symptoms • Cough Medicine Might Not Help Adults, Either • Parents Warned Camphor Can Be Toxic to Children • FDA Warns of Cough, Cold Medicine Risk to Children • Feds Find Kids Getting High On Cough Meds • Honey May Relieve Children’s Cough • Kids’ Cough Medicine Recalled Over Dosing Issue • Kids' Cough & Cold Remedies Under Fire • Drug Companies Withdraw Infant Cold Remedies • Coughs and Colds in Kids: A Doctor's Advice • FDA Cracks Down On Cough Medicine For Kids • FDA Targets Cough Medicine For Kids Under Two • Experts: Skip The Cough Medicine • Despite the Ads, Cough Syrup Does Little Good • FDA Warns Against DXM Abuse --- • More Health News ...

Responding to petitions by pediatricians and studies finding widespread use of ineffective and unsafe over-the-counter chiildren's cough and cold medicines, the U.S. Food and Drug Administration (FDA) says it will revise its standards for the products.

The action could be the beginning of the end for the syrups and pills many parents turn to when their kids come down with the sniffles. Numerous studies have found the medications do no good and may be dangerous. Drug industry spokesmen say they're safe and effective when used properly.

The FDA's action is hardly being taken in haste. The agency said it will hold a hearing Oct. 2 at which it will consider what the next step should be, how to measure the safety and effectiveness of cold products, how dosages should be determined and whether a prescription should be required for commonly used medicines.

Consumer advocates expressed pleasure with the announcement, however, and said they expected it would eventually lead to the products being pulled from the market.

In January, the FDA warned parents and caregivers that over-the-counter cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur.

That warning came three months after the drug companies recalled large batches of kids' cough medicine because the bottle caps didn't accurately measure the dosage.

Widely used

Safe or not, the medicines are unfailingly popular with parents, studies have found.

Research led by Katherine O'Donnell, M.D. of Children's Hospital Boston reveals a third of children under the age of two with bronchiolitis had received over-the-counter cough and cold medicines in the week prior to visiting an emergency room.

Guidelines released by the American College of Chest Physicians in 2005 indicate that many of the active ingredients in cough remedies may be ineffective. Americans spend $3.5 billion annually on over-the-counter cough remedies, but experts quoted by the Harvard Health Letter have said much of this money is wasted.

Given these findings and the fact that non-concentrated cough and cold formulations remain available for over-the-counter use, the authors encourage physicians to counsel all parents of young children about these ineffective and potentially dangerous medications.

While the study did not identify a specific high-risk demographic group for targeted educational interventions, factors including daycare attendance, second-hand smoke exposure, recent antibiotic use and presence of wheezing were associated with increased use of cough and cold medications. Children less than a year old, as well as those with a history of hospitalization, were less likely to use these medications.

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