Entries in Cold Medicine (2)


FDA Warns of Unapproved Rx Cold Meds

Photo Courtesy - Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration announced Wednesday there are nearly 500 prescription cough, cold and allergy drugs that are not approved and should not be on the market.

The FDA highlighted brands such as Cardec, Lodrane, Organidin and Pedia-Hist, many of which, the agency says, have issues with excessive amounts of active ingredients.  Deborah Autor, director of compliance at the Center for Drug Evaluation and Research, also noted that some extended-release formulas do not function properly and others consist of two or more active ingredients, raising the risk of over-sedation.

"We don't know what's in them, whether they work properly, or how they are made," Autor told reporters.

Autor added that many of these drugs had failed FDA testing, but many physicians are unaware of their FDA status, particularly because they are still listed in the Physicians Desk Reference and can be advertised in medical journals.

Manufacturers of the drugs previously listed with the FDA, but are unapproved, must stop producing them within 90 days and stop shipping within 180 days, Auto said.  Those that have not filed with the FDA must cease manufacturing and shipping of their products immediately.

A complete list of the unapproved prescription products can be found at the agency's website.

Copyright 2011 ABC News Radio 


Majority of Parents Still Give Young Children OTC Cough, Cold Medicine

Photo Courtesy - Getty Images(ANN ARBOR, Mich.) - A new poll suggests that, despite research linking hundreds of deaths in young children to over-the-counter cough and cold medicine, a majority of parents still give it to their children, reports Consumer Affairs.

The study, by C.S. Mott Children’s Hospital, found that 61 percent of American adults who have children under the age of two have given those children OTC cough or cold medicine in the past 12 months, regardless of a 2008 recommendation by the FDA that children under the age of two should not be given the products.

“FDA warnings about OTC cough and cold medicines prompted a voluntary recall of products marketed for children younger than two years,” said Matthew Davis, M.D., associate professor in the Child Health Evaluation and Research Unit at the University of Michigan Medical School. “We wanted to see how well parents and physicians were adopting those recommendations. Unfortunately, this latest poll indicates that the FDA warnings have gone unheeded by the majority of parents, and surprisingly, many physicians.”
Study authors say a majority of parents were told by their child's physician that the medications were safe.

Copyright 2011 ABC News Radio

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