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As parents, we are concerned with our children’s health. Recently, over-the-counter (OTC) cold and cough medications for children less than 2 years of age have received considerable attention. Several medications have been recalled following the deaths of children who overdosed on these medications. Now, the US Food and Drug Administration (FDA) has reviewed the matter and released a Public Health Advisory.
Issued on January 17, 2008, the advisory recommended that over-the-counter cold and cough medications not be used to treat infants and children under the age of 2 because of serious and potentially life-threatening side effects.
The FDA’s recommendation is based on both the review of the information received about serious side effects in children and the discussion and recommendations made at the October 18–19, 2007 public advisory committee meeting at which this issue was discussed.
The FDA’s scientific advisors concluded that cough and cold medicines pose a serious risk to small children and, according to Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products, "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2." They further recommended that these medicines should not be used on anyone younger than 6 years old, although the agency is still reviewing the data regarding these medications and children 2-11 years old. Their decision is expected by spring.
In the meantime, the FDA’s advisory recommends the following for children 2 years of age and older:
- Checking the “active ingredients” section of the DRUG FACTS label. This will help you understand what “active ingredients” are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one “active ingredient” (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
- Being very careful if you are giving more than one OTC cough and cold medicine to a child. Many OTC cough and cold medicines have more than one “active ingredient.” If you use two medicines that have the same or similar “active ingredients” a child could get too much and overdose. For example, do not give a child more than one medicine that has an antihistamine.
- Carefully following the directions in the DRUG FACTS part of the label.
- Only using the measuring spoons or cups that come with the medicine or those made specially for measuring drugs.
- Choosing OTC cough and cold medicines with childproof safety caps and storing the medicines out of the reach of children.
- Understanding that using OTC cough and cold medicines are intended only to treat your child’s symptoms. These medications won’t make your child get better any faster. They are just meant to make the time they are sick more tolerable.
- Not using these products to sedate your child or make children sleepy.
- Call a physician or healthcare provider if you have any questions regarding the medication
Drug companies last October stopped selling dozens of OTC cold and cough medications targeted specifically to babies and toddlers. These medications have a variety of rare, serious side effects. They include rapid heart rates, convulsions, decreased levels of consciousness, and death. The Centers for Disease Control and Prevention reported last year that more than 1,500 babies and toddlers wound up in the emergency room over a 2 year period because of these OTC drugs.
Dr. Holly Cleney, a family practitioner at Community Care’s Latham Medical Group, understands the dilemma parents face when their children are sick. “Parents always try to do the right thing for their children. It’s even more difficult at that age when children can’t talk to you and tell you what hurts. Parents feel the need to provide relief fast. As a mother myself, I understand that,” said Dr. Cleney. In this case however, it’s better to wait it out than give them medications that probably won’t help and have such potentially dangerous side effects. Understand that your child has a virus; it will be uncomfortable, but it will pass and those medicines won’t make it pass any faster.
With cold season still upon us, it’s important to understand the dangers of these medications. If your sick child is over the age of 2, you should still be cautious—consult your child’s doctor before giving cough and cold medications, especially if they are the combination variety (containing more than one active ingredient).
Consider these alternatives to cold medicines:
- Use humidifiers
- Place saline drops in the nose
- Drink plenty of fluids
- Take extra time for rest/naps/sleeping at night
- Give lots of hugs and kisses—tender loving care can go a long way with an uncomfortable child
Parents can follow these steps to prevent colds:
- Keep babies under 3 months old away from people with colds, as much as possible.
- Make sure your child has received all of the recommended immunizations. While they won’t prevent colds, they will help prevent some of the complications of colds, such as bacterial infections. Influenza vaccine protects against influenza but not against other respiratory viruses.
- Handwashing is the most important way to reduce the spread of colds.
- Teach children to prevent spreading colds by covering the nose and mouth with tissues when they sneeze or cough, by disposing of tissues immediately in a wastebasket, and by washing their hands after wiping the nose or handling tissues.
- Avoid sharing toys that young children place in their mouths until the toys have been cleaned.
- If your child attends daycare, tell the caregiver about any symptoms and ask if your child should stay away from daycare that day. Plan ahead by making arrangements for when your child becomes ill or when everyone else at the daycare is ill to avoid spreading germs.
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