FDA clamps down on timed-release cold meds

The U.S. Food and Drug Administration (FDA) is clamping down on the production of some timed-release cold medicines. Timed-release meds that contain an expectorant called guaifenesin are not officially approved, the FDA says. In fact, more than 20 companies make timed-release cold and cough meds that contain guaifenesin, including popular prescription medications such as Guaifenex, Crantex and Amibid, but only the over-the-counter meds marketed as Mucinex and Humibid have been approved by the FDA.

Companies making the meds must stop producing them by August 27, the FDA says, and they can be shipped no later than November 25, 2007.

The FDA is requiring that these medications be approved in order to ensure that the active ingredient is effective and is released safely over time, a spokesperson said. And from now on, any timed-release version of an existing medication must be separately approved by the agency.

Prescription and over-the-counter meds that contain guaifenesin in an immediate-release format are not part of the clampdown.

If you’d like more information, or would like to see a list of all medications not approved by the FDA, head here.