Cold remedies put children at risk, group says
Which group?
Oh Yeah, a leading group of Pediatricians tired of watching the little tykes keel over or drop into psychosis from cold medicine.
I wonder what the media and FDA response would be if Vitamin C was causing children to have heart and liver failure? Or if echinacea and goldenseal was dropping the little ones like flies.
Here is my flu natural remedies blog post: GO Here.
We made it through cold and flu season with no major illness. Just a bit of dizzyness and a few days home from school when various children were exhausted from the incredible pace they all keep.
I believe all cold rememdies marketed to children should be banned as the toxic swirling mass of deadly chemicals that they are.
Jenny Hatch
Some of the text of the article, with highlights:
The petitioners asked the FDA to tell the public that over-the-counter cough and cold remedies are ineffective and potentially dangerous for young children.
The petitioners also urged the agency to tell drugmakers that continued 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.
“These are very senior pediatricians,” Sharfstein said. “That kind of expertise is not something the FDA gets petitions from every day.”
Last fall, Sharfstein wrote the FDA to express his concern about the FDA’s regulation of over-the-counter cold remedies to children. He got a letter of thanks, but “nothing since then,” he said.
He then launched a review of FDA regulation of the products, and found that the agency has never conducted a thorough review of the scientific evidence of the drugs’ safety and effectiveness in children.
It “doesn’t make sense,” Sharfstein said. “And we were able to get some really impressive people to agree.”
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.
The FDA has not restricted marketing to young children on the grounds that the drugs are “generally recognized as safe and effective.” But a growing body of evidence in recent years has suggested that they are not.
Last year the American College of Chest Physicians released clinical practice guidelines advising caregivers not to recommend cough suppressants and other over-the-counter medications for young children because of their ineffectiveness and the increased risk of complications and death.
Last month, the Centers for Disease Control and Prevention reported that 1,519 children younger than 2 were treated in emergency rooms in 2004 and 2005 for overdoses and other complications related to cough and cold medications. Three infants less than 6 months old died.
“Because of the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children aged [less than] 2 years, parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting a health care provider,” the report concluded.
In some children, unintentional overdoses have caused heart rhythm changes, cardiopulmonary arrest, hallucinations, psychoses, hypertension and seizures, according to research cited in the petition.
The medications’ lack of efficacy means “there is no justification to tolerate a real risk of severe side effects,” the petitioners argue.
Dr. Steven J. Czinn, chair of pediatrics at the University of Maryland School of Medicine, was one of the petition’s signers. He said parents concerned about their kids’ cough and cold symptoms should have them examined by a physician to be sure the illness is viral, without serious complications.
“As long as the child is generally healthy, the best thing to do is let the virus run its course, and generally they’ll get better as quick or quicker than when they take these medicines,” Czinn said.
If a child has significant respiratory distress, or wheezing, he said, “there are medications that are effective. But routine coughs, colds, sniffles and runny nose — they’re very uncomfortable for the child, and for parents — but generally speaking these [over-the-counter] medications are not going to deal with that discomfort.”