**FILE** Pedia Care Infant Drops Long-Acting Cough and Concentrated Tylenol Infants' Drops Plus Cold & Cough are shown in a medicine cabinet at the home of Carol Uyeno in Palo Alto, Calif., in this Oct. 11, 2007 file photo. Parents should not give babies and toddlers over-the-counter cough and cold medicines they're too risky for tots so small, the government will declare Thursday. (AP Photo/Paul Sakuma, file)
October 2, 2008
WASHINGTON (AP) - 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 Thursday 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.
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.
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
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
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
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.
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.