# 5878
With cold and flu season on the way, this is probably a good time to remind my readers that the CDC and the FDA continue to warn parents over the use of many over-the-counter (OTC) cough and cold medications in young children.
In January of 2008 the FDA issued a warning to parents that OTC 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 this announcement, the debate over the safety and effectiveness of these same medications for older children continued, with some experts calling to ban their use for children under the age of 6.
In a bit of a pre-emptive strike, in the fall of 2008 the CHPA (Consumer Healthcare Products Association ) announced that its members were voluntarily modifying the product labels on many of their OTC meds to state "do not use" in children under 4 years of age.
Despite these recommendations, and the publicity they generated, old habits apparently die hard.
Earlier this year the C.S. Mott Children’s Hospital National Poll on Children’s Health indicated 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.
For parents, watching their child suffer from a cold or flu can be very difficult, and so the impulse 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 and the CDC believe those risks outweigh any benefit they might derive from these types of products.
This from the CDC.
Cold and Cough Medicines: Information for Parents
It's winter, and parents may be tempted to reach for over-the-counter medicines to ease their child's sniffling and coughs. But recent safety concerns have prompted drug manufacturers to change their labels stating that cough and cold medicines should NOT be given to children younger than age 4. Parents can take some steps now to help keep their children safe.
Each year, thousands of children under age 12 go to emergency rooms after taking over-the-counter cough and cold medicines. Most of these children were unsupervised when they took the medicine.
In response to safety concerns, the leading manufacturers of children's cough and cold medicines are voluntarily changing the labels on these products to state that they should not be used in children younger than 4 years of age.
Adding to the risks, in December of 2010 we saw a study (see JAMA: Inconsistent Dosing Instructions For OTC Meds) demonstrating the dangerously ambiguous labeling of measuring devices, and inconsistent instructions, on many cough and cold medicines.
And in August of last year (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.
The question remains, what can a parent do to help relieve their child’s symptoms without resorting to potentially harmful OTC meds?
Again the CDC has some suggestions that may help.
Symptom Relief
