FDA Panel Warns on Cold Medicines for Children Under 6

Kids Drugs Pulled Off ShelvesA FDA panel has warned that over-the-counter (OTC) cold and cough medicines do not work in children and that they should not be used in children less than six years old. The medicines the FDA Panel is warning about includes decongestants, antihistamines and antitussives but not expectorants. Over a dozen cold products for infants were recently pulled off store shelves. UPI reports that the panel has voted 13 to 9 to also ban cold medicines targeted at kids 2 to 5 years old. However, products for kids aged 2 to 5 years old have not been banned by the FDA.

A CNN article says that one member of the panel – the patient representative – was concerned that if there were no child drugs available then parents would use adult medications instead.

While the panel overwhelmingly said the products haven’t been proven to work in children 11 and younger, the panel, by a vote of 15 to 7, stopped short of recommending the products not be used at all in older children.

Amy Celento-Stamateris, the patient representative on the panel, said if there were no children’s cold and cough products on the market, “there are many people who will administer (adult) products to their children because they work for them and I’d be very concerned.”

An MSNBC article says the news has really confused parents. There is no cure for a cold virus so many parents use the OTC drugs to soothe their child’s symptoms. Parents with kids with allegy and asthma may be extra concerned when a child comes down with a cold.

The advice has left many parents wondering what to do when their kids are suffering from stuffy noses, sniffles or hacking coughs.

“You’ve got to take it seriously. I want to be cautious,” says Alison Schwartz, a 36-year-old mom who lives in Sacramento, Calif. “But on the other hand, it’s really hard with a child – especially a kid under 6 – to watch him up all night coughing, with a cold or the flu, and not be able to give him something to give him a little relief, just so he can get some sleep.”

Like many parents, Schwartz argues that the over-the-counter cold medicines have always seemed to work for her son, 3-year-old Owen.

The FDA meeting came just a week after several manufacturers pulled sales of nonprescription cold drugs targeted at children under 2. The move followed questions by the FDA and other health groups over a number of reported deaths linked to the remedies in recent years. The deaths occurred when parents gave their children accidental overdoses.

It’s troubling news for many parents who now aren’t sure how to best care for a child with a cold.

A New York Times article says mothers are split over the news. An MSNBC article says these methods are best for infants with colds.

  • 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.

    The FDA also recently issued this warning about infants and cold drugs. You can also find information from the Consumer Healthcare Products Association (CHPA) at otcsafety.org.

    Permalink | Recent Headlines | News Feeds

  • Leave a Comment

    Your email address will not be published.