FDA targets unapproved cough and cold drugs

Published May 26, 2007

WASHINGTON - Manufacturers of unapproved extended-release cough and cold drugs that contain the expectorant 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 by Aug. 27. The drugs are sold both by prescription and over the counter, and as both single-ingredient and combination products.

The 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.

Only 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. Friday's move by the FDA immediately benefited the Chester, N.J. company: Its shares were up 9.86 percent, to $44, in early afternoon trading.

The FDA identified Crantex and Guaifenex as among the biggest selling names of unapproved guaifenesin medicines, as of 2006. Crantex's distributor, Breckenridge Pharmaceutical Inc. of Boca Raton, will halt distribution by the deadline, said Larry Lapila, vice president of business development. A message left with Ethex Corp., the St. Louis company that distributes Guaifenex, was not immediately returned.

Any company that wants to sell medicine containing guaifenesin in timed-release form must seek FDA approval, the agency said. Approval would be subject to patent rights held by Adams Respiratory Therapeutics.

Fast Facts:


Guaifenesin has been used in medicine for decades. It thins the mucus in the air passages and makes it easier to cough and clear the airways. It relieves the coughs of colds, bronchitis, and other lung infections. Side effects can include headache, upset stomach and vomiting.

Source: nlm.nih.gov