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Drug companies: No cold medicine for children under 4

Overdosing worries and severe reactions lead FDA, drug companies to rethink policy on administering cold medicine to children.

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In January, the U.S. Food and Drug Administration issued an advisory urging parents to avoid using over-the-counter cough and cold products to treat children 2 years old and under.

The American Academy of Pediatrics supported that recommendation, though they pushed for the guidelines to extend to children 6 years old and younger.

Tuesday, the companies that make the products agreed that guidelines should be set, taking the middle of the road by recommending that their products not be used for anyone 4 years old and younger.

Linda Suydam, president of the Consumer Healthcare Products Association, said the companies voluntarily made the change in guidelines “out of an abundance of caution.” The caution comes from reports from the FDA and pediatricians who believe the effects of the drugs aren’t worth the risk.

“Our concerns are mostly in small children, and we realize that cold medicines really don’t work anyway,” said pediatrician Mario Sangillo of Jones, Daly, Coldren and Associates in Mechanicsburg. “You will find that the same dosage of medicine can be different among children, especially those who are sensitive to medicines. It might make one child restful enough to go to bed and it may make another dramatically lethargic and in danger of building, especially when it comes to small children.”

The FDA’s report in January claimed there have been serious adverse reactions from children associated with the products, including convulsions, rapid heart rates, decreased levels of consciousness and death. The report added that problems with OTC cough and cold medicines account for about 7,000 children heading to the emergency room each year with symptoms including hives, drowsiness and unsteady walking.

Overdosing problem

However, those severe reactions are usually caused by overdosing on medicine, according to Sangillo.

“The concern is the risk of overdose in these medicines,” Sangillo said. “It happens to medicines that are used in large populations, and there have been episodes of severe consequences, like seizures of even death in regard to overdosing or giving a medicine too great for the age of the child. It’s easy to make a mistake. It might say teaspoon, and they get a tablespoon. People just don’t think through it.”

That danger of overdosing is also why federal health officials are not going to take the children’s brands of medicine off the shelves so they can avoid desperate parents giving adult medicine to their children.

Sangillo realizes that many parents, especially new parents, may get antsy when it comes to making sure their children are comfortable. According to Sangillo, parents just don’t know when they are able to take care of things themselves and when it’s time to see a doctor.

“Young children can have a fever during a cold for three or five days, and that’s not uncommon,” Sangillo said. “I’d say it would be good to come in if the sick child is overly lethargic, and not just from a cold, but they also don’t make good eye contact or is breathing heavily. It’s also a bad sign if the child has severe or prolonged coughs. Parents have just got to use their judgment.”

Sangillo still encourages parents to call or come in if they’re worried and also suggests that, overall, the $287 million spent every year on OTC cough and cold products would be better spent elsewhere.

“The message we should all take is that cold medicine really doesn’t work, and we should be using things our grandmother used, like humidification, nasal saline and just take extra fluids. It’s OK to put [vapor rubs] on the chest to help breathing, just don’t take oral antihistamines.”

— The Associated Press contributed to this report