The Controversy of Over- the- Counter Cough and Cold Medication for Children

Imagine going to the drug store or your local supermarket and walking into the pharmacy aisle looking for over the counter cough and cold medications for your sick 3 year old child, you notice that on the labels of the cough and cold medications there are no dosing information for treating infants younger than 5 years of age. The current drugs are labeled for children 6 years and older. Why have all the labels changed and how come none of the drugs have dosing instructions for ages 5 year and younger?

The reason for this started around October 2006, a group of chief pediatrics from the Baltimore Area, the Maryland Chapter of American Academy of Pediatrics, Dr. Janet Serwint of John Hopkins and Baltimore City Health Department all joined together to issue an advisory to parents for over the counter cough and cold medications for children ages five and under. In recent years doctors have reported serious injuries and death, and studies have failed to show effectiveness in children. The group petitioned to the commissioner of the FDA to 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. And that they notify manufacturers of these products whose labeling uses such terms as “infant” or “baby,” or displays images of children under the age of 6 that such marketing is not supported by scientific evidence and manufacturers will be subject to enforcement action at any time. The FDA should also amend 21 CFR 341 to require that labeling for over-the-counter antitussive, expectorant, nasal decongestant, antihistamine, and combination cough and cold products state that these products have not been found to be safe or effective in children under 6 years of age for treatment of cough and cold and that these products should not be used for treatment of cough and cold in children under 6 years of age.


Sharfstein J. (2007 October 18).Over the Counter Cough and Cold Products for Children Under Age 6
Retrieved October 16 2009, from FDA's Website:

www.fda.gov/ohrms/dockets/ac/07/slides/2007-4323s1-03-Petitioner-Sharfstein.ppt - 2007-11-15


Monday, October 26, 2009

Things to know before giving your child otc medications

To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the "Drug Facts" box on the package label.
Here's what parents should know about using cough and cold products in children:
* 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 over-the-counter or prescription medicines 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. Do not give medication 2 years and younger
* For liquid products, parents should use the measuring device, such as the 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, such as the 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.

Reference:

Yeaton A. (2007 August 17).Nonprescription Cough and Cold Medicine use in Children.Retrieved website from: http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm078927.htm

Sunday, October 25, 2009

Alternatives to cough medication.

A news broadcast in 2008 out of Albuquerque, New Mexico gives some alternatives to the popular, but dangerous OTC cough/cold medication.







Reference:
Jones, Christine.(2008 January 14).Alternatives to Cough Medicines for kids. Healthbeat-KOATTV.com Retrieved Oct 24 2009 from http://www.youtube.com/watch?v=ZcEjRDY27Bo

Voluntary Withdrawl of Infant Cough, Cold Medications by Drug Makers

On August 15, 2007, the FDA issued a health advisory report warning parents not to give over the counter cough and cold medications to children under the age of 2. This recommendation is due to autopsy confirmed infant deaths directly related to complications from taking cough and cold medications. Following this discovery on October 11, 2007, the Consumer Healthcare Products Association (CHPA) announced on behalf of various drug maker and distributors the voluntary withdrawal of their over the counter infant cough and cold medications. 


The following is a list of branded infant cough and cold medication that were voluntary pulled from the market:

Dimetapp Decongestant Plus Cough Infant Drops
Dimetapp Decongestant Infant Drops
Little Cold Decongestant Plus Cough
Little Colds Multi-Symp
tom Cold Formula

PEDIACARE Infant Drops Decongestant
PEDIACARE Infant Drops Decongestant & Cough
PEDIACARE Infant Dropper Decongestant
PEDIACARE Infant Dropper Long-Acting Cough
Robitussin Infant Cough DM Drops

Triaminic Infant & Toddler Thin Strips Decongestant
Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough
TYLENOL Concentrated Infants Drops Plus Cold

TYLENOL Concentrated Infants Drops Plus Cold & Cough


The CHPA president Linda Suydam stated in a news release that the voluntary action was not due to the ineffectiveness or safety of the medication, but due to the trend of over use and abuse of the medications that led to over dosing infants on these drugs. The medications were effective and safe taken at the recommended dose.

Smith, M. (October 11, 2007). Infant Cough, Cold Drugs Withdrawn. Retrieved from http://blogs.webmd.com/healthy-children/2007/10/infant-cough-cold-drugs-withdrawn.html

Saturday, October 24, 2009

Infant Deaths Assoicated with OTC cough and Cold Medicaitons in Infants.

Between 2004-2005 there have been neglects of mislabeling that has lead to an estimated 1500 deaths in children 2 years and younger. The CDC and National Association of Medial Examiners did an investigation of U.S. infants aged 12 months and younger with the association of cough and cold medications. The report showed substantial evidence for causes of death in infants due to cough and cold medications. In the report the death of  three infants, ages ranging from 1 to 6 months, was due high levels of pseudoephedrine (a nasal decongestant) in the post mortem blood samples. Their blood levels of pseudoephedrine ranged from 4743ng/ml to 7100ng/ml. One of the infants had received a double dose of otc cough and cold medication and a prescription. The other two infants had a high blood level of dextromethorphan and acetaminophen. All three infants were found dead in there homes. The Medical Examiner determined that cough and cold medications was the cause of death for each of the three infants.



Cohen A, Shehab N, Srinivasan A.(2007 January 12).Infant Deaths Associated with Cough and Cold Medications--Two States 2005. MMWR weekly 56(01), 1-4.  Retrieved from the MMWR website: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm

Friday, October 23, 2009

Parents just don't know.

A study conducted by various pediatricians from September 1, 2006 to October 16, 2007 shows the flaw in parental care when it comes to OTC cough/cold medicines.  The most startling evidence of dosing negligence was that of the 182 parents of infants less than two years old tested, 50% of the parents would give cough/cold medicine to their child due to misinterpretations of pictures, labels, and dosing instructions.


Reference

L. M. Sanders, J. S. Shaw, G. Guez, C. Baur, and R. Rudd. Parental Misinterpretations of Over-the-Counter Pediatric Cough and Cold Medication Labels. Pediatrics, November 1, 2009; 123: 1464-1471 

Making Assumptions Could Cost Lives

I remember when i was a kid and I got any kind of cough or cold, my parents would simply give me some kind of OTC cough or cold medication numerous times of the day depending on how sick i was. This is the case with many parents today. Many parents simply seem to pick up OTC cough or cold medications from their local drug store thinking that the labels work well for their children below 2 years of age. However, misinterpretations of the labels on the OTC drugs could cost serious complications in children. In the "Morbidity and Mortality Weekly Report (2007)" presented by Centers for Disease Control and Prevention, in the 2004 -2005 around 1,519 children less than 2 years of age were rushed to the emergency departments due to the adverse reactions of the OTC cough and cold medications provided by their caregivers. The problem is not with the medications, the problem is with the dosage of those OTC drugs. For this age group, FDA approves no dosage recommendations as studies are still being done to prove whether these drugs really help children under the age of 2. Due to the high risk of toxicity in children, caregivers should always be careful in treating cough and cold with OTC drugs in their children. Dosage and combination of drugs with the same drugs can cause serious and adverse side effects in their children which can be fatal.




Sources:


American Psychological Association.(2007). Infant deaths associated with cough and cold medications--two states, 2005. MMWR. Morbidity And Mortality Weekly Report, 56(1), 1-4.retrieved from: http://libproxy.uta.edu:2066

Thursday, October 22, 2009

Myth or Fact?

Do cough medications really work on children? If not, how to manage Cough in children?

Cough and cold are common problems among children due to viral infections. Many parents overlook the fact that when they walk to a local drug store and pick up an over the counter cough or cold medicine, they are overlooking the underlying reasons of why their children are having cough and cold? According to Kelly LK and Allen PJ, in their journal “Pediatric Nursing” many of those parents who choose over the counter cough and cold medications for their children need to rethink. According to them “the stated actions of some combination cough preparations are contradictory” and many cough medications are advertised as “multi-symptom”.


Studies done by Paul, Yoders, et al. (2004) show that OTC cough and cold medications do not help children to relieve their symptoms but only suppress the cough and cold, however they add to side effects and adverse reactions to the child’s body due to dosing errors. In 2002 the Food and Drug Administration suggested phenypropanolamine used in OTC cough and cold medications to be removed from the market due to its adverse effects to the cardiovascular system such as stroke, intracerebral hemorrhage, and high blood pressure.


If OTC cough and cold medications are not a good way to treat our sick children, how do we manage cough and cold in young children then?

References
Kelley, L., & Allen, P. (2007). Primary care approaches. Managing acute cough in children: evidence-based guidelines. Pediatric Nursing, 33(6), 515-524. http://libproxy.uta.edu:2066

Wednesday, October 21, 2009

What is the medication industry doing to help decrease overdosing?

In 2008, OTC medicine manufacturers started changing labels to help parents reduce the risk of overdosing.  Also, many OTC industry leaders are urging parents to store the medication in places that are not easily accessible to children.


Reference:
Background on Oral Cough and Cold Medications for Children. OTCsafe.org. Retrieved Oct 17, 2009 from: http://www.otcsafety.org/Parents/Background_on_Oral_Cough_and_Cold_Medicines_for_Children.aspx

Physicians support the idea of FDA regulations on pediatric

An ABC news article in April of 2007 states that many physicians are agreeing with the FDA to change regulations and dosing labels for cough syrup.  Some doctors are claiming that the drugs are not properly tested on children and infants before they are released, while some say that many problems are caused by dosage ignorance.  Industry representatives stand by their product and support the medications' efficacy, while most physicians support the claim that OTC cough medications do not even work and they supply other alternatives if a child has a cold.  The support of many doctors have caused the movement of pediatric cough medicine regulation by the FDA to stay strong.

Reference:

Child D. (2007 August 08). Docs support FDA Cough Medicine Warnings. ABCNEWS GO. Retrieved Oct 21, 2009  from http://abcnews.go.com/Health/Drugs/Story?id=3488351&page=1

Tuesday, October 20, 2009

A physicain's view on cough medication.

Back in 2007, Dr. Michael Shannon, MD, who works at Children's Hospital Boston, spoke to a panel of peers and board members on the dangers of cough/cold medication.  He points out that the medication can be especially detrimental to infants that are less than two years old.  He also states that some of the blame should be directed to the parents and caretakers that neglect to correctly read labels, but the brunt of the blame was directed towards the medication companies that do not regulate testing of the medicine in younger children.





The three main factors that Dr. Shannon states that poses the most problems are wrong dosage amounts, adverse drug interactions, and underlying illnesses.


Reference:
Shannon M. (2007 Oct. 31) Dr. Michael Shannon on cold medications. Childrens Hospital's Boston Channel News.Retrieved Oct 16, 2009 from http://www.youtube.com/watch?v=DwOYu16hpfw