Baltimore Health Commissioner Dr. Joshua Sharfstein and 15 other experts petitioned the U.S. Food and Drug Administration yesterday to tell the public that over-the-counter cough and cold remedies are ineffective and potentially dangerous for young children.
As many as 900 Maryland children younger than 5 overdosed on the medications in 2004, the petition states. The deaths of at least four children in Baltimore have been linked to unintentional overdoses in the last six years.
"Over-the-counter cough and cold preparations are neither safe nor effective for use in young children," the petitioners argue. "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."
Sharfstein and a group of pediatricians first voiced their concern about the issue at a news conference in October. Their petition, seeking formal action based on that research, also asks the FDA to tell drugmakers that marketing these products for infants and young children is not supported by scientific evidence and could lead to enforcement action.
Among those joining Sharfstein in the petition were Dr. Janet Serwint, professor of pediatrics at the Johns Hopkins University; Dr. Steven J. Czinn, chairman of pediatrics at the University of Maryland School of Medicine; and Dr. Michael Shannon, professor of pediatrics at Harvard Medical School.
Coughs and colds are frequent in young children, and parents often turn to remedies that combine cough suppressants, expectorants, decongestants and antihistamines. In 1990, sales of these products totaled nearly $2 billion.
Repeated studies have found the preparations are generally harmless but no more effective in children than placebos. But in some children unintentional overdoses have caused heart rhythm changes, cardiopulmonary arrest, hallucinations, psychoses, hypertension and seizures, according to research cited in the petition.