OTC Medicines Can Injure Toddlers


When a child is injured or sick, parents will go to great lengths to try to make them feel better. It's only natural not to want your child to suffer. However, one of the ways many parents have used to ease the symptoms of a cold is now off the table.

Drug companies have been under pressure from pediatricians, legislators and consumer groups about marketing cold and cough remedies for children. As a result, drug manufacturers started advising parents on October 7th not to use over-the-counter cold and cough medicines on children under the age of four.

A week prior to this new advisory by the drug companies, pediatricians had asked the FDA to ban over-the-counter cough and cold medications for children under the age of six. The Chicago Tribune reported that outside advisors to the FDA had said that there was no evidence that these medications worked in children under the age of 12 and that they should not be administered to children under the age of six.

The FDA has concerns that completely banning over-the-counter cold and cough medications for children under six would cause parents to misuse adult medications and guess at dosage strengths for children. This could cause unintentional overdoses and lead to avoidable injuries and deaths.

Just because a medication is available without a prescription does not mean that there are no dangers or health risks. The dosing instructions on the package of these medications must be followed closely to avoid accidental overdoses and injuries.

Currently, the FDA does say that parents should not give over-the-counter cold and cough medication to children under the age of two. It supports the voluntary action of the drug manufacturers while it conducts an ongoing evaluation of over-the-counter medications.

The Consumer Healthcare Products Association said that its member companies will begin to transition labeling on pediatric cold and cough medications that are available over-the-counter. The new labels will advise parents that these medicines are not for use in children under the age of four. Additionally, the manufacturers will be adding language to the labels of certain antihistamines to warn parents not to use the products to sedate their children or make them sleepy.

Previous Warnings about Cold Medicines

An FDA panel said last year that cough and cold medicines such as antitussives, decongestants and antihistamines should not be administered to children between the ages of two and six. The effectiveness of these types of medications has not been studied in children and the risks outweigh any benefits that the medicine may bring.

Just prior to that decision by the FDA, major drug manufacturers had agreed to take cold medicines marketed for children under the age of two off the shelves, citing the potential for misuse.

In October 2007, the FDA said with more certainty, after a 21-1 vote, that over-the-counter cold and cough medicines should not be taken by children under the age of two. However, at the same time, the panel voted 15-7 that these medications could be used by children between the ages of six and 12 although no studies have been done regarding the safety and effectiveness of the drugs for that age group.

More than 800 over-the-counter cough and cold medications are marketed in the United States, according to the FDA. Sales of these products are estimated at more than $3.7 billion annually, with $300 million of that being spent on children's cold medicines, according to Nielsen Co.

Serious Health Risks for Tots

The U.S. Centers for Disease Control and Prevention published a study of hospital emergency departments in January 2007. The study found that more than 1,500 children under the age of two were treated for "adverse events including overdoses, associated with cough and cold medications." The report also identified three deaths as a result of the use of these medications in children under the age of two.

The Salt Lake Tribune reported that doctors are concerned that parents may use leftover medication to treat children or even worse, may try to give their children partial dosages of adult medications. Doctors warn that this is extremely dangerous and many natural remedies, combined with a little patience may be far safer and more effective.

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