The review began in mid-2006 according to the agency, which has only recently revealed details after receiving a petition filed by Baltimore public health officials and others. Critics claim that OTC medicines including decongestants, antihistamines, cough suppressants and expectorants which have been tested on adults have not been tested on children and therefore have not been proved to be safe or effective.
Doses for children have been based on smaller adult doses, with children ages 6 to 12 recommended to receive half an adult dose while children ages 2 to 6 are to receive one-quarter. Current labeling advises parents to consult a doctor before giving cold or cough medicine to a child under two, but the Baltimore officials who submitted the petition want the FDA to go further and warn parents not to give cough remedies to children under the age of six.
However, the Consumer Healthcare Products Association (CHPA) believes that current guidelines are enough. “Millions of Americans safely and effectively use OTC cough and cold medicines every year – both for themselves and for their families,” said Linda Suydam, president of the CHPA.
“These medicines have been found safe and effective by the FDA and are the same medicines that families have safely relied upon for decades to help relieve cough and cold symptoms and make their children feel better.”