A top official at the U.S. Food and Drug Administration (FDA) told the New York Times this week that federal regulators have started a comprehensive review of childrenÃ¢â‚¬â„¢s cough and cold medicines. Dr. Charles J. Ganley, director of the FDAÃ¢â‚¬â„¢s office of nonprescription drug products, said the agency was Ã¢â‚¬Å“revisiting the risks and benefits of the use of these drugs in childrenÃ¢â‚¬Â and that Ã¢â‚¬Å“weÃ¢â‚¬â„¢re particularly concerned about the use of these drugs in children less than 2 years of age.Ã¢â‚¬Â
On Thursday, a group of 16 prominent and respected pediatricians, led by Dr. Joshua Sharfstein, Baltimore’s commissioner of health, petitioned the FDA with the purpose of curtailing the marketing of these remedies to children under 6. Ã¢â‚¬Å“When you see multiple deaths, hundreds of calls to Poison Control, and thousands upon thousands of kids using these drugs in the city every day, and they donÃ¢â‚¬â„¢t work and theyÃ¢â‚¬â„¢re not safe, itÃ¢â‚¬â„¢s a fair issue for public health,Ã¢â‚¬Â Sharfstein told the Baltimore Sun.
Ã¢â‚¬Å“Over-the-counter cough and cold preparations are neither safe nor effective for use in young children,Ã¢â‚¬Â the petition reads. Ã¢â‚¬Å“The FDA has never conducted an appropriate analysis to support their widespread use, and expert organizations agree that they are ineffective and pose a risk to health.Ã¢â‚¬Â
Linda Suydam, president of the Consumer Healthcare Products Association (CHPA) trade group, rejected the notion, saying: Ã¢â‚¬Å“Millions of Americans safely and effectively use OTC cough and cold medicines every year both for themselves and for their families. These medicines have been found safe and effective by the U.S. Food and Drug Administration (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.Ã¢â‚¬Â
However, critics contend that the FDA never scrutinized and studied the safety and effectiveness of these drugs especially on young children when they were first approved. Even the FDAÃ¢â‚¬â„¢s Dr. Ganley agreed that these drugs were never adequately tested on children. Ã¢â‚¬Å“We have no data on these agents of whatÃ¢â‚¬â„¢s a safe and effective dose in children,Ã¢â‚¬Â he told the Times.
In January, the U.S. Centers of Disease Control and Prevention (CDC) issued a warning about the potential hazards of administering over-the-counter cough and cold medicine to infants. Citing the deaths of three infants associated with the drugs, the CDC urged all parents to consult with medical professionals before giving the medicine to their young children.
In a Morbidity and Mortality Weekly Report published in January, the CDC notes, Ã¢â‚¬Å“Cough and cold medications that contain nasal decongestants, antihistamines, cough suppressants, and expectorants commonly are used alone or in combination in attempts to temporarily relieve symptoms of upper respiratory tract infection in children aged [less than] 2 years. However, during 2004-2005, an estimated 1,519 children [under the age of 2] years were treated in U.S. emergency departments for adverse events, including overdoses, associated with cough and cold medications.Ã¢â‚¬Â
The CDCÃ¢â‚¬â„¢s report also Ã¢â‚¬Å“identified deaths of three infants aged 6 months [and under] in 2005, for which cough and cold medications were determined by medical examiners or coroners to be the underlying cause.Ã¢â‚¬Â The CDC recommends saline nose drops or a cool-mist humidifier, followed by the use of a rubber suction bulb, as a safer treatment alternative.
Last year, the American College of Chest Physicians advised health-care providers to refrain from recommending over-the-counter cough medications for young children because of the associated risks of severe adverse effects. The FDA has not set a target dosage for children in that age group because it has not been proven that these medications are effective in treating that cohort.