The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

The Food and Drug Administration (FDA) has announced plans to revise its standards for over-the-counter cold and cough medications for kids after rising concern that the medications are not effective and could be unsafe. This step could lead to the medications being completely removed from the market. For the first time in decades, the agency says it will revamp the qualifications necessary for the drugs to remain on shelves. This announcement is the agency’s latest response to a petition filed in 2007 by pediatricians asking the FDA to restrict the use of the products. They pointed out a lack of evidence that the medications even work and the growing evidence that the drugs can cause children to hallucinate, have seizures, have trouble breathing, heart problems and other complications, sometimes even death. The pediatricians also cited the fact that at the time the medications were approved, it was considered inappropriate to test medications on children, so instead they were tested on adults, a practice that is now insufficient.

On October 2, the agency will hold a special hearing to answer questions, including: “What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available? They are trying to get these drugs monitored at the same level as prescription drugs.

Last year, a week before the FDA convened a panel to consider the doctors’ petition, drugmakers pulled all over-the-counter cough and cold medications for children under the age of two, though the companies complained the major problem was not their product but that parents were accidently giving overdoses. After an exhaustive review by the panel, they concluded that medications only work in children over the age of twelve, and recommended that they not be used at all in children under the age of six. They also called for new research to determine their safety and effectiveness directly on children.

Comments are closed.

Of Interest