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Cough and cold medicines are being pulled from stores' shelves across the nation. Federal health officials want the "consult your physician" recommendation to be removed from the labels.
The FDA wants this change for decongestants for use in children under two years of age and in antihistamines for use in kids under six.
There are approximately 800 medicines used to treat coughs and colds in children.
The FDA reviewed the side-effects records that had been filed with them from 1969 through September of 2006 and found that there had been 54 deaths in children. These deaths were found to be from the use of pseudoephedrine, ephedrine and phenylephrine. There were also 69 deaths reported that were associated with the use of antihistamine medicines that contained brompheniramine, chlorpheniramine or diphenhydramine.
Most of the deaths from both types of medicines were in children 2 years or younger.
The FDA review came after a petition was filed by Baltimore city officials who stated that many over-the-counter cough and cold medicines can harm young children and often don't work. The CDC reported that 1,500 babies and toddlers had to visit the emergency room in just a 2 year period due to use of OTC medicines.
The FDA has also told drug companies that the must stop making and selling unapproved prescription medicines for children under 6 that contain hydrocodone. Hydrocodone is a narcotic that is used as a cough suppressant and a painkiller. There are approximately 200 unapproved cough medicines made with hydrocodone. There are 7 cough suppressants that do have FDA approval.
October 25, 2007