RECALL OF CHILDREN'S COUGH & COLD MEDICATIONS

Following months of publicity and controversy surrounding the use of over-the-counter cough and cold medications in children ages two years and under, drug makers voluntarily have pulled several cold medicines off the market. The move came less than two weeks after the U.S. government warned of potential health risks to infants.

On October 11, 2007 the Consumer Healthcare Products Association (CPHA), on behalf of the leading makers of over-the counter (OTC) cough and cold medicines, announced the voluntary withdrawal of oral infant medications from store shelves.  Products aimed at children under the age of 2 are being removed from store shelves due to "rare instances of misuse" that could lead to accidental overdose.

Which medications have been recalled?

Over the counter branded pediatric cough and cold medicines affected by this voluntary withdrawal include:

• Dimetapp® Decongestant Plus Cough Infant Drops
• Dimetapp® Decongestant Infant Drops
• Little Colds® Decongestant Plus Cough
• Little Colds® Multi-Symptom Cold Formula
• PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine)
• PEDIACARE® Infant Drops Decongestant & Cough (containing pseudoephedrine)
• PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
• PEDIACARE® Infant Dropper Long-Acting Cough
• PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
• 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

What do we know about the effectiveness of these medications in young children?

As far as using cold medicines in young children, there is no proven benefit and definite proven risk. Guidelines issued last year by the American College of Chest Physicians noted that over-the-counter cough medications had "little, if any, benefit" in children, and antihistamines had "minimal" effect.  "As weak as the data are for adults, it is even weaker or less existent for kids. There is little or no compelling data that they worked," says Peter Dicpinigaitis, a New York City pulmonologist who co-authored the guidelines.

Instead, pediatric and public health groups recommend that parents use more traditional methods, including:

• Plenty of fluids and rest.
• Suction bulbs to gently clear infants' clogged noses. Saline nose drops loosen thick secretions so noses drain more easily. 
• A cool-mist humidifier in the child's bedroom. 
• Acetaminophen or ibuprofen, as recommended by your doctor, to alleviate pain or discomfort -- but check that they don't contain extra ingredients. 
• Some chest creams can ease stuffiness with menthol or other fragrances, but check labels for age restrictions.

What else consumers should know:

• Infants under the age of two are the most vulnerable to the consequences of  misuse. Rare cases of fatal overdose from misuse of children’s OTC cough and cold medicines have occurred—particularly in infants less than two years of age.
• The voluntary withdrawal only affects oral infant cough and cold medications. It does not affect any other children’s medicines.
• OTC pediatric cough and cold medicines affected by this voluntary withdrawal can also be referenced on the web by visiting:  www.OTCsafety.org.
• As with any medicine, it is important for parents to read the labels carefully, use these medicines only as directed, and make sure to safely store them out of the reach of children. As with all medicines, It is important to remember that any medicine can cause harm if taken or used improperly
• Harm from OTC cough and cold medicines is rare and, when it does occur, is almost always the result of misuse (significant overdose or accidental swallowing due to medicine not being properly stored and secured). Safe use and safekeeping are extremely important. Giving medicine according to label directions is part of the solution; storing it out of the sight and reach of children is part of it, as well.

ADDITIONAL PRECAUTIONS

1. Always read and follow the Drug Facts label on your OTC medicine. This is important for choosing and safely using all OTC medicines. Read the label every time, before you give the medicine. Be sure you clearly understand how much medicine to give and when the medicine can be taken again.
2. Know the "active ingredient" in your child’s medicine. This is what makes the medicine work and is always listed at the top of the Drug Facts label. Sometimes an active ingredient can treat more than one medical condition. For that reason, the same active ingredient can be found in many different medicines that are used to treat different symptoms. For example, a medicine for a cold and a medicine for a headache could each contain the same active ingredient. So, if you’re treating a cold and a headache with two medicines and both have the same active ingredient, you could be giving two-times the normal dose. If you’re confused about your child’s medicines, check with a doctor, nurse, or pharmacist.
3. Give the right medicine, in the right amount, to your child. Not all medicines are right for an infant or a child. Medicines with the same brand name can be sold in many different strengths, such as infant, children, and adult formulas. The amount and directions are also different for children of different ages or weights. Always use the right medicine and follow the directions exactly. Never use more medicine than directed, even if your child seems sicker than the last time.
4. Talk to your doctor, pharmacist, or nurse to find out what mixes well and what doesn’t. Medicines, vitamins, supplements, foods, and beverages don’t always mix well with each other. Your healthcare professional can help.
5. Use the dosing tool that comes with the medicine, such as a dropper or       a dosing cup. A different dosing tool, or a kitchen spoon, could hold the wrong    amount of medicine.
6. Know the difference between a tablespoon (tbsp.) and a teaspoon (tsp.). Do not confuse them! A tablespoon holds three times as much medicine as a teaspoon. On measuring tools, a teaspoon (tsp.) is equal to "5 cc" or "5 ml."
7. Know your child’s weight. Directions on some OTC medicines are based on weight. Never guess the amount of medicine to give to your child or try to figure it out from the adult dose instructions. If a dose is not listed for your child’s age or weight, call your doctor or other members of your healthcare team.
8. Prevent a poison emergency by always using a child-resistant cap. Re-lock the cap after each use. Be especially careful with any products that contain iron; they are the leading cause of poisoning deaths in young children.
9. Store all medicines in a safe place. Today’s medicines are tasty, colorful, and many can be chewed. Kids may think that these products are candy. To prevent an overdose or poisoning emergency, store all medicines and vitamins in a safe place out of your child’s (and even your pet’s) sight and reach. If your child takes too much, call the Poison Center Hotline at 1-800-222-1222 (open 24 hours every day, 7 days a week) or call 9-1-1.
10. Check the medicine three times. First, check the outside packaging for such things as cuts, slices, or tears. Second, once you are at home, check the label on the inside package to be sure you have the right medicine. Make sure the lid and seal are not broken. Third, check the color, shape, size, and smell of the medicine. If you notice anything different or unusual, talk to a pharmacist or another healthcare professional.