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FDA to Review Safety of Cold Remedies for Kids

Reports of hospitalizations, even deaths, in children younger than 2

THURSDAY, Aug. 16, 2007 (HealthDay News) -- Responding to growing concerns about the safety and effectiveness of cough and cold drug products used by young children, U.S. health officials said Wednesday that they will meet in October to reassess the medications.

The U.S. Food and Drug Administration said "questions have been raised about the safety of these products" and whether the risks outweigh the benefits, particularly for children younger than 2 years old.

Federal officials said use of over-the-counter medicines have been blamed for "adverse events" that led to more than 1,500 children under 2 years of age to be treated in hospital emergency rooms since 2004. And the U.S. Centers for Disease Control and Prevention says it knows of at least three deaths tied to use of the medications in children younger than 2.

To prepare for the Oct. 18 meeting, the FDA said its Nonprescription Drugs Advisory Committee will review safety data on the ingredients and dosing levels for the products.

In a prepared statement released Wednesday, the FDA said reports of serious adverse events appeared to be the result of giving too much of these medicines to children. Over-the-counter cough and cold medicines can be harmful if more than the recommended amount is used, if they are given too often, or if more than one cough and cold medicine containing the same active ingredient is used, the statement said.

Baltimore health officials have been in the forefront of the push to get the FDA to reevaluate the safety of the drugs, and to require warning labels that state the products "have not been found to be safe or effective" for children under 6, the Baltimore Sun reported Thursday.

Dr. Joshua M. Sharfstein, the city's health commissioner, said the drugs have been linked to the deaths of four Baltimore children under 4 years of age in the last six years, the newspaper said.

Dr. Robert Ancona, chief of pediatrics at St. Joseph Medical Center in Towson, Md., said the deaths may be due to be a cough suppressant, dextromethorphan, which is used in many of the over-the-counter remedies. The parents apparently overdosed their children when the youngsters didn't respond to a more appropriate dose, he told the Sun.

To avoid giving a child too much medicine, the FDA recommends that parents carefully follow the directions for use of the product in the "Drug Facts" box on the product label.

The FDA also offered several other suggestions, including:

  • Do not use cough and cold products in children under 2 years of age unless given specific directions to do so by a health-care provider.
  • Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children -- sometimes called "pediatric" use.
  • Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a health-care provider.
  • If other medicines -- over-the-counter or prescription -- are being given to a child, the child's health-care provider should review and approve their combined use.

In March, the FDA said it was reviewing the safety of children's over-the-counter cold and cough remedies.

Dr. Charles Ganley, the FDA's director of the Office of Nonprescription Products, said at the time that the agency has been "looking into the issue of safety of children's cough medicine since the middle of last year." He noted that when these medicines were originally approved, in some cases several decades ago, there was no mandate that the effectiveness, safety or dose be determined for children; rather, the guidelines were extrapolated from studies done with adults.

"We have not established a dose that is safe for children 2 and under," Ganley said during a teleconference. "We hope to have our review done in several months and then make recommendations."

When these drugs are taken in higher-than-normal doses, they can affect the heart's electrical system, leading to arrhythmias, which are irregular heartbeats. Some medicines affect the blood vessels and, in high doses, have been associated with high blood pressure and stroke. In rare cases, children have been injured even when given recommended doses, The New York Times reported.

A group of prominent pediatricians and public health officials petitioned the FDA in March to stop drug makers from marketing cold and cough medicines for children under 6. The petition said the medicines do not work and, in rare cases, can cause serious injury.

When the FDA initially approved the drugs for pediatric use, it had determined they were safe and effective for children aged 6 to 12, Ganley said. The agency is looking at data from newer studies to see if the drugs are effective, he said.

In the Jan. 12 issue of the CDC's Morbidity and Mortality Weekly Report, researchers noted that cough and cold medicines can be harmful and should be used with caution in children under 2 years of age.

The CDC had identified three infants who died from the toxic effects of cough and cold medicines in 2005. In addition, in 2004 and 2005, more than 1,500 children younger than 2 years old were treated in emergency rooms for adverse events from cough and cold medicines, the report said.

The report also noted that although these drugs are effective in older children and adults, there's little evidence the medications help in children under 2 years old. "Parents should always consult a health-care provider before giving cough or cold medicine to kids under 2 years old. Health-care providers should use caution when giving cough and cold medicines to children under 2 years old," the report concluded.

The Consumer Healthcare Products Association, which represents the over-the-counter drug industry, believes these medicines are safe and effective.

"These medicines have been found safe and effective by the FDA and are the same medicines that families have safely relied upon for decades to help relieve cough and cold symptoms and make their children feel better," Linda A. Suydam, president of the Consumer Healthcare Products Association, said in a prepared statement released in March.

More information

For more about colds and cold medications for young children, visit the American Academy of Pediatrics.

SOURCES: Aug. 15, 2007, statement, U.S. Food and Drug Administration; March 2, 2007, statement, Consumer Healthcare Products Association, Washington, D.C.; U.S. Centers for Disease Control and Prevention, Atlanta
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