Cold medicines dangerous for children

Cough and cold medication use in young children has been linked to a significant number of adverse effects and several deaths, leading the FDA to recommend against their use for children less than two years old. Despite these concerns about safety and efficacy, there has been little research on patterns of cough and cold medication use in very young children. Now, a new study from the Emergency Medicine Network led by Katherine O’Donnell, M.D. of Children’s Hospital Boston reveals important new statistics about medication use in children under the age of two.

According to the study, 1-in-3 children under the age of two with bronchiolitis (a lower respiratory tract infection associated with runny nose, cough, wheezing and/or difficulty breathing) had received over-the-counter cough and cold medicines in the week prior to visiting an emergency department. This study identifies rates and predictors of cough and cold medication use prior to the manufacturer recall of and FDA recommendations against use of these medications in children younger than two years of age. “After the recall and labeling changes, it will be important to monitor for potential ongoing use of these medicines in young children and observe if parents or physicians are turning to other therapies in place of these medications,” says O’Donnell. Given these findings and the fact that non-concentrated cough and cold formulations remain available for over-the-counter use, the authors encourage physicians to counsel all parents of young children about these ineffective and potentially dangerous medications. While the study did not identify a specific high-risk demographic group for targeted educational interventions, factors including daycare attendance, second-hand smoke exposure, recent antibiotic use and presence of wheezing were associated with increased use of cough and cold medications. Children less than a year old, as well as those with a history of hospitalization, were less likely to use these medications.

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“Pediatricians groups are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6.
The effectiveness of the medicines in children was never proved, critics say, and problems with the drugs send thousands of kids to the emergency room every year.
“When a treatment is ineffective, its risks – unless zero – always exceed its benefits.” Dr Michael Shannon of Children’s Hospital in Boston told the FDA PANEL.

US families spend at least $286 million a year on such cold and cough remedies for children, according to the Nielsen Co. market research firm.
In any given week, the medicines are used by an estimated 10 per cent of all children with the biggest exposure among 2 to 5 year olds, a recent Boston University report found.

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Cold medicines for kids need more study, FDA says
By RICARDO ALONSO-ZALDIVAR Associated Press
Oct. 2, 2008, 1:07PMShare Print Email Del.icio.usDiggTechnoratiYahoo! BuzzWASHINGTON — Parents wondering whether to give cold and cough medicines to their kids may not get help from the government anytime soon.

Food and Drug Administration officials at a public hearing today said they need to gather more data on whether over-the-counter remedies are safe and effective for children ages 2-6. The FDA is also worried that a ban — as sought by leading pediatricians' groups — might only drive parents to give adult medicines to their youngsters.

"That is a concern for us," said Dr. John Jenkins, who heads the FDA's Office of New Drugs. "We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation."

With a new cold season coming, pediatricians are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6. The effectiveness of the medicines in children was never scientifically established, critics say, and problems with the drugs send thousands of kids to the emergency room every year.

"When a treatment is ineffective, its risks — unless zero — always exceed its benefits," Dr. Michael Shannon of Children's Hospital in Boston told the FDA panel.

The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers — and officials are not giving a timetable for a decision.

U.S. families spend at least $286 million a year on such cough and cold remedies for children, according to the Nielsen Co. market research firm. In any given week the medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds, a recent Boston University report found.

But colds usually clear up on their own after a few days. Many doctors say rest and plenty of fluids are what it takes to get over a cold.

The industry says OTC medicines have been used for decades in treating kids' colds and are safe for those older than 2. Nonetheless, manufacturers are planning to carry out new studies involving the most common ingredients in the medications. The companies voluntarily stopped selling cough and cold medicines for babies and toddlers last fall.

FDA advisers said that was not enough and recommended that the drugs not be used for children younger than 6. An expert panel said children older than 2 could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.

It turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids.

Cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses.

The same ingredients usually are found in different products. For example, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

The Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them.


"The data clearly show a majority of adverse events are direct result of misuse of our products," said Linda Suydam, who heads the industry group.

Baltimore health commissioner Dr. Joshua Sharfstein sought to reassure FDA officials worried about unintended consequences if the government moves to restrict the medications and parents start dispensing adult drugs to their preschoolers. Sharfstein said the state of Maryland saw an immediate benefit after OTC cough and cold remedies for tots were removed from store shelves last fall. Calls to poison control about problems with the medicines involving children younger than 2 dropped by 40 percent, from 99 to 60, in the first six months of this year when compared with 2007. Calls involving children 2 to 6 also dropped, but by much less.

"The feared increases in poisonings simply did not happen," said Sharfstein. "In fact, the opposite occurred."