From foodconsumer.org
OTC cough, cold medicines neither effective nor safe
By Sue Mueller
Aug 16, 2007 - 9:40:44 AM
If you like the article, could you please do us a favor? Just tell Google News Services that you like foodconsumer.org included in Google News Services. Inclusion in googlenewsservices means many more people can read articles like this. Thanks.
------
The US Food and Drug Administration Wednesday issued a public health advisory to warn parents not to give over-the-counter cough and cold remedies to their children under the age of 2 years UNLESS given specific directions to do so by a healthcare provider because of some safety and efficacy issues.
Cough and cold medications that contain nasal decongestants, antihistamines, cough suppressants, and expectorants are commonly used alone or in combination in attempts to temporarily relieve symptoms of upper respiratory tract infection in children aged under the age of 2 years, according to the CDC.
The FDA did not specify what adverse effects could be associated with use of these cough and cold medicine in young children, but it did say these over-the-counter nonprescription drugs if used too often and at high doses can cause harm to the children.
The Centers for Disease Control and Prevention reported in early March that "during 2004--2005, an estimated 1,519 children aged under the age of 2 years were treated in U.S. emergency departments for adverse events, including overdoses, associated with cough and cold medications."
The CDC confirmed that “three cases of infant deaths in two states during 2005 that were determined by a medical examiner or coroner to have been caused by cough and cold medications."
The FDA statement is weak compared to what was stated by a group of physicians in a citizen petition to the federal agency to put tough restrictions on marketing and use of over-the-counter cough and cold medications because they said these remedies are not effective, not safe, and not generally recognized as safe and effective.
The petition was submitted early in March 1, 2007 by Baltimore City Health Department on behalf of a group of doctors from Baltimore City Health Department, St. Agnes Hospital, Johns Hopkins Hospital, University of Maryland, and many others.
The petitioners came to conclude that "Over the counter cough and cold preparations are neither safe nor effective for use in young children. FDA has never conducted an appropriate analysis to support their widespread use, and expert organizations agree that they are ineffective and pose a risk to health. Deaths and serious injuries have been linked to misuse of these medications."
The doctors petition that the FDA:
1) Provide a statement to the public explaining that over the counter antitussive, expectorant, nasal decongestant, antihistamine and combination cough and cold products have not been shown to be safe and effective for the treatment of cough and cold in children under six years of age;
2) Notify manufacturers of these products whose labeling 2) uses such terms as "infant" or "baby" or 2) displays images of children under the age of 6 that
a. Such marketing is not supported by scientific evidence; and
b. Manufacturers will be subject to enforcement action at any time.
3. Amend 21 CFR 341 to require that labeling for over-the-counter antitusive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products state:
a. These products have not been found to be safe or effective in children under 6 years of age for treatment of cough and cold.
b. These products should not be used for treatment of cough and cold in children under 6 years of age.
Dr. Charles J. Ganley, director of the office of nonprescription drug products at the FDA told the Times early in March that “we’re particularly concerned about the use of these drugs in children less than 2 years of age.”
At high doses, the ingredient(s) in cold medicines can affect the heart’s electrical system, leading to arrhythmias. Some medicines affect the blood vessels, potential leading to hypertension and stroke. Children may get injured even at recommended doses.
But the FDA said early it could not expect new regulations in response to a petition filed by prominent pediatricians and public health officials that demand that drug makers stop marketing those cough and cold medications to children under age 6.
Doctors said many popular medicines such as Toddler’s Dimetapp, Infant Triaminic and Little Colds should not be given to children younger than age 6 while they are marketed to children as young as 2.
Because of the efficacy and safety issues associated with the OTC cough and cold medications, the American Academy of Pediatrics issued a policy statement early in 1997 advising that parents should be educated regarding lack of antitussive effects, risk for adverse events, and potential for overdose in children from the cough suppressants such as codeine and dextromethorphan.
In 2006, the American College of Chest Physicians also released clinical practice guidelines for management of cough, advising health-care providers not to recommend cough suppressants and other over-the-counter cough medications for young children because of potential risks to children.
The FDA has been reviewing the risk and benefits of popular over-the-counter cough and cold remedies indicated for young children since early this year, according to an early New Yorker Times report.
The Nonprescription Drugs Advisory Committee will meet in October to discuss the safety and effectiveness of cough and cold drug product use in children as questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, according to the FDA.
For now, the FDA recommends the following:
Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider.
Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called “pediatric” use).
Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a healthcare provider.
If other medicines (over-the-counter or prescription) are being given to a child, the child’s healthcare provider should review and approve their combined use.
Read all of the information in the “Drug Facts” box on the package label so that you know the active ingredients and the warnings.
Follow the directions in the “Drug Facts” box. Do not give a child medicine more often or in greater amounts than is stated on the package.
Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.
For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.
If a measuring device is not included with the product, parents should purchase one at the pharmacy. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the “Drug Facts” box on the package label, or is recommended by the child’s health care provider.
If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device (dropper, dosing cup or dosing spoon), DO NOT USE the medicine. Consult your healthcare provider if you have questions or are confused.
Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold. Children get better with time.
If a child’s condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.