FDA orders a halt to unapproved cough drugs

Manufacturers of unapproved extended-release cough and cold drugs that contain an expectorant called guaifenesin have until Nov. 25 to stop shipping the medicines, health officials said Friday.

The Food and Drug Administration said about 20 companies make hundreds of timed-release medicines containing guaifenesin that have never undergone agency review. They are expected to stop making the drugs even earlier, by Aug. 27.

The drugs are sold both by prescription and over the counter, and as both single-ingredient and combination products.

Friday’s action does not affect products containing guaifenesin in immediate-release form, the FDA said.

The agency said it knew of no safety issues with guaifenesin, which has been used in medicines for decades. The drug stimulates removal of mucus from the lungs.

Only one company, Adams Respiratory Therapeutics Inc., has FDA approval to sell extended-release guaifenesin.

In 2002, the FDA approved single-ingredient versions of the medicines, sold as Mucinex and Humibid.

In 2004, the FDA approved combination versions of Mucinex that included either a cough suppressant or a decongestant.

Any company that wants to sell medicines containing guaifenesin in timed-release form must seek FDA approval, the agency said.

Approval, however, would be subject to patent rights held by Adams Respiratory Therapeutics, it added.