Consumer and medical groups clashed over the issue of over the counter cough and cold medications for children at an FDA hearing today, with some groups calling on the agency to pull them off of shelves and make them available by prescription only.
That could affect as many as 800 cough and cold medications in the U.S. market.
“A lot of people don’t know that the FDA has never required companies to show their products are effective,” according to Paul Brown with the National Research Center for Women and Families.
Dr. Joshua Sharfstein with the Baltimore City Commissioner of Health urged cough and cold meds for children should be recalled. He initiated the review of their safety and effectiveness last year after complaining to the FDA that children were overdosing on the medications.
Some with the FDA fear that parents in need of nighttime cold relief, might turn to adult formulations for their kids, which has the potential for even more harm.
But Food and Drug Administration officials at the public hearing also said they were not comfortable with the lack of safety data that would support keeping OTC remedies available for children under the age of six.
"We don't see that adequate evidence of efficacy has been demonstrated in children to date," said Dr. John Jenkins, the head of the FDA’s Office of New Drugs. "It really is a conundrum for us.”
There is no timetable for any FDA decision. So where does this leave parents?
The American Academy of Pediatricians (AAP) believes OTC products should not be given to children under the age of six because of serious side effects. Outside advisers agree with that assessment. But the FDA officially says that parents should not give medication to toddlers under the age of two. That’s a position that the drug manufacturers share with the FDA.
The OTC remedy market is estimated to bring about $286 million a year to drug companies, according to the Nielsen Co. market research firm, reports the AP.
Dr. Sharfstein says when cold and cough remedies were removed from store shelves last fall, calls about unintentional poisoning dropped by in children young than two, by forty percent. He does not believe parents will harm their children by giving them adult versions of medications.
Background (Update 1)
The Food and Drug Administration (FDA) is meeting with the public today to figure out whether controversial cold medications for youngsters should remain over-the counter (OTC).
Topics discussed varied from the age range for dosing, whether tests should be conducted on children, and how they should be designed.
This follows last January’s advisory recommending cough and cold meds such as cough suppressants, antihistamines, expectorants, and decongestants, not be used to treat toddlers under the age of 2.
In response, drug makers removed the remedies from store shelves. No official recall was issued or initiated.
Between 1969 and 2006, an FDA review found that 54 children’s deaths were associated with decongestant medications made with pseudoephedrine, phenylephrine or ephedrine.
69 deaths were reports associated with diphenhydramine, brompheniramine or chlorpheniramine. Most of the children were under the age of 2. The reports followed a lawsuit by a group of pediatricians who felt the cough and cold meds had never been proven safe.
The Centers for Disease Control and Prevention reports 7,000 American children under the age of 11 are treated in hospital emergency rooms every year because of reactions to cold and cough medications.
Overdosing can occur when parents give two different products with the same active ingredients or give too much of a dose too frequently.
It is considered unethical to test drugs in children.
However, Dr. Michael Spigarelli, an assistant professor of pediatrics and internal medicine at Cincinnati Children's Hospital, who will testify at the hearings, says that 150 0r so drugs have been tested since the Best Pharmaceuticals for Children Act passed in 2002.
He tells U.S. News that the act gives drug companies an extended marketing time if the drug is found useful in younger age groups.
An estimated ten percent of American kids take cold medications every week.
Most of the time, a cold will go away by itself in about a week.
Your doctor may recommend taking in plenty of fluids to help loosen mucus and using saline nasal drops. Occasionally a fever reducer such as acetaminophen or ibuprofen is recommended. If symptoms do not improve or get worse, contact your doctor. #