A number of pharmaceutical companies, including Novartis, Wyeth Labs, and Johnson & Johnson are withdrawing infant over-the-counter cough medicine because of concerns of death and injury due to possible overdose.
The announcement was made by the Consumer Healthcare Products Association, the trade group representing the companies.
Though the industry insists the recalled medicines are safe in recommended doses, over-the-counter cough medicines in general have come under closer scrutiny in recent months.
On October 1, the FDA said it will take enforcement action against companies marketing cough and pain medications for children that contain hydrocodone. The agency says the narcotic has not been approved for treatment of coughs and colds in children, though it has been cleared for other, limited uses.
Its important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately, said Linda A. Suydam, D.P.A, president of CHPA.
The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority.
The voluntary withdrawal affects only these "infant" oral medicines, not those intended and labeled for use in children age two and older.
The branded cough and cold medicines that are being voluntarily withdrawn are:
Dimetapp Decongestant Plus Cough Infant Drops
Dimetapp Decongestant Infant Drops
Little Colds Decongestant Plus Cough
Little Colds Multi-Symptom Cold Formula
PEDIACARE Infant Drops Decongestant (containing pseudoephedrine)
PEDIACARE Infant Drops Decongestant & Cough (containing pseudoephedrine)
PEDIACARE Infant Dropper Decongestant (containing phenylephrine)
PEDIACARE Infant Dropper Long-Acting Cough
PEDIACARE Infant Dropper Decongestant & Cough (containing phenylephrine)
Robitussin Infant Cough DM Drops
Triaminic Infant & Toddler Thin Strips Decongestant
Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough
TYLENOL Concentrated Infants' Drops Plus Cold
TYLENOL Concentrated Infants' Drops Plus Cold & Cough
CHPA said it and its member companies have made recommendations to the U.S. Food and Drug Administration to strengthen the labels on all oral over the counter childrens cough and cold medicines from "ask a doctor" before using to "do not use" in children under two years.
CHPA said it made these recommendations to the FDA in preparation for a joint FDA advisory committee meeting on October 18 and 19.
Dr. Henry Fishman, ConsumerAffairs.coms medical correspondent, says parents should be leery of multi-symptom five-in-one cocktails that can be purchased over the counter.
They can have five or six drugs at a time, when your child just needs one or two, he said. Not a single over-the-counter multi-symptom cough or cold medicine has been adequately tested in kids under six and frankly, a lot of the stuff does not work.
Even adults should think twice for spending money on over the counter cough remedies, according to experts.
Guidelines released by the American College of Chest Physicians earlier this year indicate that many of the active ingredients in cough remedies may be ineffective, reports the May issue of the Harvard Health Letter.
Americans spend an estimated $3.5 billion annually on over-the-counter cough remedies.