Months after drugmakers
pulled infant cold remedies from most pharmacy shelves, the FDA warns consumers
of their life-threatening side effects
by Zoe Galland
Three months after a group
of pharmaceutical companies voluntarily recalled cough and cold medicine for
children under the age of 2, the Food & Drug Administration has issued its
own public health advisory stating that parents should not give infants
over-the-counter products because of possible life-threatening side effects.
The FDA notice, however,
will not surprise parents who have sought out the medicine at some point during
the past three months. Most
Despite the voluntary
recall stripping almost all of the tainted medicines from pharmacy shelves, the
FDA believes it was necessary to put out an official recommendation. "Even
though a number of manufacturers withdrew [the infant cold and cough
medicines], there's a likelihood that a number of parents still have these
medications in the home, and that they might be tempted to use them despite the
information that came out in October," says Dr. Daniel Cobaugh, director
of research at the American Society of Health-System Pharmacists Research&
Education Foundation in Bethesda, Md.
It is difficult to
estimate how many parents are still using recalled infant cough meds or buying
cough meds for older children, which they then give to infants. Recent surveys,
however, have shown that many parents believe over-the-counter medicines for
children and infants pose no threat to their kids' health.
A poll conducted by
National Public Radio, the Kaiser Family Foundation, and the Harvard School of
Public Health in December found that 58% of parents surveyed believed medicines
available in their local pharmacies were at least "somewhat safe" for
children between the ages of 2 and 6. Sixty-two percent of parents also said their
doctor at some point had recommended that they use an over-the-counter cold or
cough medicine for their children.
Many pediatricians,
however, strongly discourage parents from using the products, as do most public
health officials. Dr. Charles Ganley, the FDA's nonprescription drugs chief,
says in the FDA's Jan. 17 statement that infant medicines "have not been
shown to be safe or effective in children under 2."
Side Effects Can Be Fatal
Parents who have used the
medicines for years without noticing problems may wonder what is unsafe about
them or assume that a few parents' incorrect dosages are unfairly affecting the
parents who give out the proper dosage. But pediatricians who criticize the use
of cold and cough medicine say the ingredients in the medicine make children
hyperactive and irritable and can even be fatal. In 2005, the Centers for
Disease Control reported that, over a period of a year, more than 1,500 babies
and toddlers ended up in emergency rooms after being given cough and cold medicine
.
"If you look at
ingredients in OTC meds," Cobaugh says—which include antihistamines,
decongestants, cough suppressants, and expectorants—"each of these has the
potential for some toxicity." He says that in the cases that were reported
by the CDC, "there were decongestants involved in those cases, but
dextromethorphan [a cough suppressant] was also involved, as well as
acetaminophen."
Cobaugh also notes that
many of the ingredients in infant cold meds are also in meds for children over
the age of 2. The FDA, however, still has to decide whether to adopt the
recommendations of its advisory committee regarding cold medicines for children
over 2. For now, Cobaugh cautions, parents should be cautious and "make
sure that they follow dosing instructions."
The debate over both
infants' and children's cold medicines has been especially intense since
August, 2007, when the FDA issued a public health advisory notice stating that
a group of government advisors would meet in October to discuss the medicines.
The group concluded that the meds were not safe for children under 6. In
December, 2007, The New England Journal
of Medicine published an editorial urging the FDA to ban the
medicine.
A Spoonful of Sugar
There may be a safer and
simpler alternative to children's cold meds. In a study in the December issue
of Archives of Pediatrics and
Adolescent Medicine, researchers gave 105 children with colds
honey, honey-flavored cough medicine, or no treatment. All of the children got
better, but parents rated honey as most effective in treating their children's
colds.
Honey eventually may be one of the few options left to parents if the FDA issues another advisory, on cold meds for children over 2. It is unclear when they will decide, however; Ganley would only say in the statement, "the FDA is committed to making a timely and comprehensive review of the safety of OTC cough and cold meds in children."