FDA to Review Cold Remedies for Kids

Some doctors say the drugs can be dangerous, particularly for the very young

FRIDAY, March 2, 2007 (HealthDay News) -- U.S. health officials said Friday that they are 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 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.

On Thursday, a group of prominent pediatricians and public health officials petitioned the FDA 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 ages 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 U.S. Centers for Disease Control and Prevention'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.

One expert said these medications are ineffective and are potentially dangerous for young children, and the FDA needs to decide whether these medicines should be available or not.

"These medicines have not been adequately tested on young children," said Dr. Ian M. Paul, an assistant professor of pediatrics and health evaluation sciences at Penn State College of Medicine and a spokesman for the American Academy of Pediatrics.

"These medications have not been shown to be effective," Paul added. "The doses have been made up and extrapolated from adult doses, and particularly with high doses, parents often mis-dose, and these medicines have the potential to be dangerous."

Another expert agreed that the FDA needs to carefully assess the safety and benefits of these medicines.

"Taking a careful look at these medications to judge their safety, efficacy and appropriate use is a long time coming," said Dr. Michael Marcus, the director of pediatric pulmonology, allergy and immunology at the Maimonides Infants & Children's Hospital, in New York City.

"The FDA should mandate that for these drugs to be on the market, there should be some good scientific studies that would prove their safety and efficacy, no different than any other medication," Marcus said. "It may be reasonable to make these drugs available by prescription."

Paul noted that these medications are often marketed for very young children. "The FDA needs to say what the place is for these medicines," he said. "The American Academy of Pediatrics and the American Academy of Chest Physicians have come out and said that some of these medications shouldn't be made available to children."

Popular medicines like Toddlers Dimetapp, Infant Triaminic and Little Colds, which are marketed for use in children as young as 2, should not be given to children younger than 6 under any circumstances, the petition filed Thursday with the FDA said, according to the Times.

The Consumer Healthcare Products Association, which represents the non-prescription 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.

"Current FDA assessment of the safety and efficacy of approved children's over-the-counter antitussives, expectorants, nasal decongestants, antihistamines, and combination cough cold products is based on scientific studies in children and/or on extrapolation from extensive data in adults," Suydam added. "This process of extrapolation follows internationally recognized recommendations for diseases which are similar in adult and pediatric patients and applies to the symptoms and conditions for these medicines."

Penn State's Paul said that for children with colds, recommended measures include appropriate doses of acetaminophen or ibuprofen to relieve discomfort. The child should also be kept well hydrated, he said. "For colds, saline nose drops can help. Colds should get better. If they get worse, that's the time to see a doctor," he said.

More information

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

SOURCES: Ian M. Paul, M.D., M.Sc., assistant professor of pediatrics and health evaluation sciences, Penn State College of Medicine, Hershey, Pa.,, and spokesman, American Academy of Pediatrics; Michael Marcus, M.D., director of pediatric pulmonology, allergy and immunology at the Maimonides Infants & Children's Hospital, New York City; March 2, 2007, statement, Consumer Healthcare Products Association, Washington, D.C.; U.S. Centers for Disease Control and Prevention, Atlanta; March 2, 2007, teleconference with Charles Ganley, M.D., director of the Office of Nonprescription Products, U.S. Food and Drug Administration
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