WASHINGTON - Cold and cough medicines should not be given to children younger than 6 because they don't help them and aren't safe, pediatricians seeking to curb their use told government health advisers yesterday. Such a prohibition would go beyond last week's move by drug makers to eliminate sales of the nonprescription drugs targeted at children under 2.
The doctors petitioned the Food and Drug Administration advisers seeking, in part, a government statement saying the medications shouldn't be used in children under age 6 either. The advisers began a two-day meeting to consider the issue.
The FDA has yet to act, in part pending a recommendation expected from a joint panel of outside specialists in pediatrics and nonprescription drugs, said the agency's Dr. Joel Schiffenbauer.
The medicines have been marketed for use in children for decades, with drug companies spending $50 million a year on heart-tugging ads in parenting magazines and elsewhere. Still, it has long been acknowledged there is little data from studies in the very young to show the medicines are safe and work. Some studies suggest they are no better than placebos in treating cold and cough symptoms in young children, the petitioners said.
"When a treatment is ineffective, its risks - if not zero - always will exceed its benefits," said Dr. Michael Shannon, a pediatrician at Children's Hospital Boston and a Harvard Medical School professor who was one of the petitioners.
The drug industry, meanwhile, maintains that the widely used medicines are safe and work but can lead to death and injury from overdoses or misuse in infants. It estimates children receive 3.8 billion doses of the medicines a year.
"The vast majority of consumers are using these medicines properly, and serious adverse events are rare," said Linda Suydam, president of the Consumer Healthcare Products Association, which represents drug makers.
The focus of the petition is on children under 6, but the joint panel will be asked whether there's evidence that these drugs work in children up to age 12.