FDA Officially Nixes Cough and Cold Meds for Babies and Toddlers

Amid the annual sniffling and sneezing of the cold and flu season, the U.S. Food and Drug Administration (FDA) finally issued its timely statement about the safety and effectiveness of cough and cold medicines for young kids. After a year of questions and debate from all angles, the government is affirming that these over-the-counter (OTC) remedies should never be used for children under 2 — they're not safe and do not work for babies and toddlers.

What the federal agency hasn't said yet is whether these medications are OK or even effective in older kids (ages 2 to 11) either — they're still reviewing the research. But this latest FDA warning — that these medications can have "serious and potentially life-threatening side effects" in babies and toddlers — echoes previous efforts to get the important word out about the risks of using these medications in the littlest of kids.

In January 2007, the Centers for Disease Control and Prevention (CDC) warned parents not to use the meds in infants and toddlers after three babies' deaths in 2005 were linked to the toxic effects of cough and cold medicines, which sent more than 1,500 kids under 2 to emergency rooms in 2004 and 2005.

In October 2007, drug-makers took the proactive step of voluntarily yanking 14 popular cough and cold medicines labeled for babies and toddlers from the market. Although the FDA hadn't made its official call yet, the manufacturers erred on the side of caution to prevent parents from misusing and accidentally overdosing their young tots on these OTC drugs stocked in millions of medicine cabinets.

A Closer Look at the Concerns

Although the cough and cold medications for kids under 2 targeted by the FDA ruling are no longer on the shelves, they may still be found in many households. These "infant" products' titles alone are extremely misleading because they imply that they're tailored to and, therefore, safe for babies. So, many parents may mistakenly assume that if "infant" or "toddler" is in the title of an OTC cough or cold drug, it must be OK for really young children. Not so.

Despite the medications' names, there was actually never an FDA-approved dosage of OTC cough and cold remedies for kids under age 2. That's why the dosing tables on the labels say only "ask a doctor" for kids under 2.

Unfortunately, the message to seek medical advice before giving the medications can be easily overlooked or downplayed as well-meaning parents scramble to give their child something to make it all better — an honest mistake that can prove deadly.

And now, health officials agree that it's never OK to give these meds to babies and toddlers, no matter what the old labels say. With risks like convulsions, increased heart rates, and lowered levels of consciousness, potentially fatal overdoses of cough and cold medicines can happen in babies and toddlers when they're given:

• more than the amount recommended for their age and weight
• doses of medication too often
• more than one cough and cold medication — OTC and/or prescription — with the same ingredient(s)

In one fell swoop, these OTC drugs may deliver multiple strong medicines like cough suppressants, decongestants, expectorants, and antihistamines, as well as pain relievers and fever-reducers such as ibuprofen and acetaminophen. Decongestants, for one, can cause hallucinations, irritability, and irregular heartbeat in babies and toddlers.