FDA to Review Children's Cold Remedies

It seems that children’s cold medicines that have been in use for decades may not have gotten rigorous FDA review when they were first introduced. Subsequently, the popularity of the various brands may have made the FDA reluctant to review their safety and effectiveness. From the NYT:

The agency has for decades promised to review systematically the safety of all old drugs, but for a variety of reasons like budgetary constraints, time and popularity of a particular drug has not done so.

We, like the reader who sent this story in, find it troubling that “popularity” is a factor in deciding whether or not to review the safety of a drug. The New York Times doesn’t explain in detail what is meant by this quote, but we’re hard pressed to think of any explanations that would make us say, “Wow, that’s really awesome.”

In addition to safety, the FDA is also going to review the drugs for effectiveness, as new studies show some cold remedies are no more effective than a placebo.

“There is widespread consensus that there is no good evidence for the effectiveness of several of the compounds used in cold medicines,” said Dr. Ian M. Paul, an assistant professor of pediatrics at Penn State College of Medicine who has studied the medicines. Last year, the American College of Chest Physicians recommended that parents avoid using cough and cold medicines in children, especially young ones.

Despite these growing worries, sales of the drugs are booming. Most major pharmacies carry a dozen or more brands.

This is an article you’ll want to read if you have children, particularly children under the age of 2, as it has also has some good information on recommended dosing and ways to avoid dangerous overdose. —MEGHANN MARCO

U.S. Reviewing Safety of Children’s Cough Drugs [NYT] (Thanks, Jason!)