Federal health officials warned the drug manufacturers against selling of children medicines that contain the painkiller and cough suppressant hydrocodone. The warning applies to decongestant use in children under 2, and antihistamines in those younger than 6, according to agency documents released Friday.
The FDA said in a statement that manufacturers of any other unapproved hydrocodone medicines, beyond those intended for young children, must stop making them by Dec. 31 and cease shipping them by March 31, 2008. The order applies to most of the hydrocodone formulations sold as cough medicines.
The FDA aims to remove an estimated 200 unapproved prescription cough medicines from sale that are made with the narcotic. The officials will discuss this issue at length during an Oct. 18-19 meeting.
The FDA's review was triggered by a recently filed petition by Baltimore city officials, in collaboration with American Academy of Pediatrics, who charged that many over-the-counter cough and cold remedies can harm toddlers and preschoolers.
The FDA also added that the "consult your physician" advice to parents on the labels be dropped. Dr. Joshua Sharfstein, Baltimore's health commissioner told the Associated Press, "It does not make sense, in the absence of information, to say 'consult a physician,' because they do not have superhuman powers."
"They cannot make a product safe or effective," he added.
After reviewing the side-effect records between 1969 and September 2006, the federal health officials found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine.
Nearly 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine were also found on children younger than 2.
The order does not apply to pain-relief drugs like Vicodin, which combine hydrocodone and acetaminophen. It also does not include other hydrocodone formulations, including the seven cough suppressants made with the narcotic that are approved by the FDA approval.
