WASHINGTON -- Baltimore's health commissioner told federal regulators yesterday that children's over-the-counter cough and cold remedies are ineffective and dangerous for youngsters under age 6.
Speaking before a Food and Drug Administration advisory panel, Dr. Joshua M. Sharfstein led a group of pediatricians making a case for their petition to have the FDA bar pharmaceutical companies from marketing the remedies for young children.
"There is a gap in federal oversight," Sharfstein said. He said loose FDA regulations enable drug companies to market medications to children with little evidence that they work and despite mounting evidence of adverse reactions and, in rare instances, death.
Industry representatives disagreed, blaming adverse reactions on caregivers who do not follow dosage instructions and questioning the accuracy of reports of harm. The best evidence, they said, is the experience of millions of consumers and generations of children.
"How is the purchase of hundreds of millions of doses by parents to be explained?" asked Dr. George S. Goldstein, an industry representative on the advisory panel. "I don't believe the caregiver or parent is ... stupid."
The two-day hearing, which continues today, was prompted by a petition that Sharfstein and other doctors filed in March, asking the agency to re-evaluate its guidelines for the over-the-counter medications.
Their petition urged the FDA to formally acknowledge that there is no evidence that the medications are safe and effective for children younger than 6 and to require manufacturers to note that on labels. It also asked the FDA to ban marketing of the drugs for use in children under 6.
The advisory panel is expected to made recommendations to the FDA after the hearing.
Amid publicity over the petition, manufacturers last week voluntarily withdrew from store shelves 14 products marketed for use in infants. But the real battle is expected over the much larger market for youngsters between the ages of 2 and 6.
Sharfstein testified yesterday with three other doctors, including Dr. Daniel J. Levy of Owings Mills, president of the Maryland chapter of the American Academy of Pediatrics.
Sharfstein said clinical trials have shown that parents and doctors have difficulty telling whether medications are relieving a child's symptoms.
Levy said misleading marketing preys on harried parents. He said parents often ask him how to dispense medications.
"I'll ask them to open the bottle," he said, "and in one easy motion invert it over the toilet."
The pediatricians noted reports of adverse reactions. In 2005, the U.S. Toxic Exposure Surveillance System recorded 88,000 calls about overdoses or adverse reactions in children that involved cough and cold medicines and antihistamines.
An FDA report last month found that from 1969 to 2006, there were 54 deaths involving decongestants and 69 involving antihistamines.
Dr. Michael Shannon, a professor of pediatrics at Harvard Medical School, told the panel yesterday that adverse reactions to such medications marketed for children can include hallucinations, agitation, seizures and cardiac arrest. He noted that dosage guidelines were approved more than 30 years ago and are based on testing on adults.
But industry representatives said most adverse reactions are the result of adults failing to follow the label.
"The vast majority of consumers are using the medicines properly, and serious adverse events are rare," said Linda Suydam, president of the Consumer Healthcare Products Association, which represents drug manufacturers.
Dr. Richard Dart of the Rocky Mountain Poison and Drug Center said reports of adverse reactions can be misleading because most of the problems are not serious.
Of 1,073 such calls to Maryland's poison center in 2004, he said, only five cases proved to be medically significant and none involved fatalities.