FDA urged to recall cold medicines for youngsters...
By RICARDO ALONSO-ZALDIVAR, Associated Press Writer
Thu Oct 2, 6:01 AM ET
With a new cold season coming, the government is trying once more to decide what to do about over-the-counter medicines for kids' coughs and sniffles. Doctors question the drugs' benefits and worry about their risks.
Pediatricians are urging the Food and Drug Administration, which scheduled a public hearing Thursday on the issue, to demand a recall of the medicines for children younger than 6.
"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," said Dr. Joshua Sharfstein, Baltimore's health commissioner. "There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6."
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 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.
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 carrying 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 older children 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.
But Sharfstein said 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.
Experts from around the world are recommending 2,000 IU's of vitamin D3 for kids, especially in the fall and winter months and 4,000 IU's for adults.
Video - Vitamin D Deficiency and Illness - Especially Flu prevention...
Here is a great way to get kids to take D3, in a pleasant cherry flavored liquid.
Lifetime Liquid D3 Mixed Berry -- 16 fl oz
NSI - Vitamin D3 - 2000 IU's 300 capsules
It is also true that vitamin C is very good for preventing colds.
Here is a great tasting liquid C 1000. Consider using 1 table spoon a day for children.
Dynamic Health Liquid Vitamin C -- 1000 mg - 16 fl oz
The Vitamin C Foundation feels that 3,000 mgs per day should be the minimum daily allowance for adults.
NSI Vitamin C -- 1,000 mg - 250 Capsules - Ascorbic Acid is what your body would produce if it was able. We have lost the enzyme necessary to do so.
Christopher Wiechert's Healthblogger is for educational or informational purposes only, and is not intended to diagnose or provide treatment for any condition. If you have any concerns about your own health, you should always consult with a health care professional. If you decide to use this information on your own, it's your constitutional right, but I assume no responsibility. The views expressed on this website are those of the health professionals & scientists I list or my own opinions and are not intended to replace any medical advice you may require. The contents have not been approved by the Pharmaceutical Association, the American Medical Association, or the Food and Drug Administration. This website may present views diametrically opposed to the views of such organizations.
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" The significant problems we face cannot be solved at the same level of thinking we were at when we created them." Albert Einstein