Cold Meds Not Safe for Kids Under 2, FDA Warns

Decision on kids aged 2-12 expected this spring, officials add

The U.S. Food and Drug Administration on Thursday issued a public health advisory stating that over-the-counter cough and cold medicines should not be given to infants and children under the age of 2.

Although concern about the safety of these medications when used in the very young has been widely aired in recent months, FDA officials said they were concerned the public wasn't getting the message.

"We strongly recommend that over-the-counter cough and cold products should not be used in young children under 2, because serious and potentially life-threatening side effects can occur from use of these products," Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products, said during a morning news conference. "We have not come to a final decision on the use of cough and cold products in children aged 2 to 11 and continue to work within [the] FDA to arrive at a decision."

"We were concerned that parents would continue to use these products in children under 2, even with all the publicity," Ganley added.

"The public health advisory from the FDA is definitely a good thing," said Catherine Tom-Revzon, clinical pediatric pharmacy manager at Children's Hospital, Montefiore Medical Center, in New York City. "A lot of health-care professionals, including myself, have always taken the approach of not giving medication to children where there isn't enough evidence to show that it's safe and actually works. This actually supports that idea, so it gives more credibility when we speak to patients about this."

"I'm a parent of a toddler myself, and my daughter has had multiple colds, and it is difficult to watch and not do anything," she noted. "Now, parents are being told that they can't give medication. It's probably going to be difficult for them to accept, but the reality is it's better to be safe by not giving medication that could potentially harm young children. It's the right thing to do."

Last November, the FDA became aware of a number of surveys that indicated that individuals or parents were continuing to use the products without getting advice from a health-care provider.

The medicines, which include decongestants, expectorants, antihistamines and cough suppressants, have been associated with different rare but serious events including convulsions, rapid heart rates, decreased levels of consciousness, and even death.

A review of records filed with the FDA between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. Most of the deaths involved children younger than 2.

The current advisory is based on an agency review of data and recommendations discussed during a joint meeting of the Nonprescription Drugs and Pediatric Advisory committees last October. The committees recommended a ban on cold medicines in children under the age of 2.

Right before the meeting, makers of dozens of cough and cold remedies targeted to infants voluntary recalled these products. In particular, products with pictures of infants on the label or use of the word "infant" in the name were taken off shelves. Overall, there are approximately 800 popular cough and cold medicines sold in the United States. Experts estimate that Americans spend about $2 billion annually on these types of medications.

An internal working group at the FDA was not able to come to a consensus as to recommendations for children aged 2 to 11. A decision on this issue is expected by the spring.

Dr. Lisa Mathis, associate director of the FDA's Office of New Drugs, Pediatric and Maternal Health Staff, had this advice for those caring for children over the age of 2:

• Always remember that these medications do not cure colds, they don't shorten the time the child has the cold and are only meant to help a child's symptoms.
• If you choose to give medication, look at the active ingredients' section of the label and what symptoms each active ingredient is intended to treat.
• Be very careful in giving more than one over-the-counter cough and cold medication to your child. Remember that many OTC cough and cold products have multiple medications in them. If you use two medications with similar active ingredients, this could hurt a child.
• Make sure to carefully follow directions on the label.
• Only use the dropper or cup that comes with the medicines, not household measuring devices.
• If you have the opportunity to use cough and cold medicines with childproof safety caps, you should do so.
• Store all medicines out of the reach of children.
• Call your physician or pharmacist or other health provider if you have any questions regarding the use of these medications in children 2 years or older.

"We're not trying to dictate the practice of medicine. We understand that health providers on an individual basis have to make certain decisions based on the facts presented to them, but we do need to recognize that there have been reports of serious adverse events in the less-than-2 age group related to misdosing and in attempting to choose the correct product," Ganley said. "Clearly, there have been instances where more than one product was used or it was not clear to the parent as to what the ingredients are in the products."