The U.S. Centers for Disease Control and Prevention warned parents on Thursday not to give common over-the counter cold remedies to babies and toddlers under two years of age without first consulting a doctor. The active ingredient in cold remedies such as nasal decongestants and cough suppressants is pseudoephendrine. The active ingredient in these products used to be phenylpropanolamine (PPA). Several years ago, an industry-funded study called the “Yale Study” established an association between PPA and hemorrhagic stroke. In November 2000 the FDA issued a Public Health Warning requesting that the OTC industry discontinue marketing cold remedies containing PPA. In response to pressure from the FDA, the industry eventually reformulated their cough/cold products, changing the active ingredient to pseudoephendrine (PPE). At the time, many scientists predicted that PPE posed similar risks of stroke as PPA. Both ingredients are memebers of the same drug family (along with ephedra, amphetamines, and other Class I drugs).
The Seattle Post-Intelligencer and CNN reported that
the deaths of three infants 6 months or younger in 2005 led to an investigation [by CDC] that showed the children all had high levels of …pseudoephedrine, up to 14 times the amount recommended for children ages 2 to 12. The study found 1.519 ER cases from 2004 and 2005 involving young children and cold medicine.
The Associated Press reported the following advise to parents:
Dr. Michael Marcus, director of pediatiric pulmonology, allergy and immunology at Maimonides Infants and Children’s Hospital in New York, said, ‘The best thing (parents) can do is support [infants with cold symptoms] with fluids and lots of kisses and time, because lots of infections are viral and will pass in a few days. The medications have a greater potential for harm than the infections your are trying to treat.’
The CDC website is http://www.cdc.gov