# 5319
In January of 2008 the FDA issued a warning to parents that OTC (over-the-counter) cough and cold remedies were no longer considered to be safe or effective for children under the age of 2.
Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age
FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age. FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.
Despite these recommendations, and the publicity they generated, old habits apparently die hard.
Three years later the C.S. Mott Children’s Hospital National Poll on Children’s Health indicates that for a majority of parents, those warnings are going unheeded.
The following excerpts are from the University of Michigan Health System’s press release:
February 14, 2011
ANN ARBOR ,Mich.
Parents continue to give cough and cold meds to young kids, despite FDA warnings
Research has linked over-the-counter cough and cold products to poisoning or death in hundreds of children, ages 2 and younger. Studies have also shown that these medicines do little to control symptoms. As a result, in 2008, the United States Food and Drug Administration formally recommended that OTC cough and cold products not be given to children under age 2.
A poll released today by the C.S. Mott Children’s Hospital National Poll on Children’s Health shows that 61-percent of parents of children, ages 2 and younger, gave their children OTC cough and cold medicine within the last 12 months. The poll also shows that more than half of parents report that their child’s doctor says OTC cough and cold medications are safe for children under 2; half of their physicians said they are effective.
Particularly concerning is the assertion by roughly half of the parents that their healthcare providers continue to recommend these products for their children under the age of 2.
The safety and effectiveness of OTC cold remedies for children between the ages of 2 and 6 is still under review by the FDA.
Complicating matters, in December we saw a study (see JAMA: Inconsistent Dosing Instructions For OTC Meds) demonstrating the ambiguous labeling of measuring devices, and inconsistent instructions, on many cough and cold medicines.
And in August 2010 (see Inappropriate Use Of OTC Medicines In Children) a study was presented at the International Pharmaceutical Federation’s (FIP) conference in Lisbon, Portugal (Aug 28th-Sept 2nd), on the widespread parental misuse of over-the-counter (OTC) medicines for children.
For parents, watching their child suffer from a cold or flu can be very difficult, and so the impulse is to `do something’ to alleviate their misery is strong.
But all medicines . . . even those available over-the-counter – have risks. And for very small children, the FDA believes those risks outweigh any benefit they might derive from these types of products.
