Drug Litigation Newsroom

The Dangers of Unapproved Time-Released Drugs

Approximately 20 firms make timed-release products containing guaifenesin that have not undergone FDA review and as a result are considered by the agency to be unapproved drugs. "Today's action is another example of our commitment to ensure all drugs marketed in the United States that require FDA approval have that approval," said Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research (CDER). "This benefits consumers because drugs that skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured." This action does not affect products containing guaifenesin in immediate release form, but rather only affects timed-release forms, often described as extended-release, long-acting or sustained-release. These dosage forms release their active ingredients over an extended period of time, reducing the number of doses needed per day. Many of the products that contain guaifenesin also contain other active ingredients that are intended to relieve nasal congestion, suppress cough, reduce fever or relieve pain.

Timed-release drugs require FDA approval because the FDA must ensure that the product releases its active ingredients safely and effectively, sustaining the intended effect over the entire time in which the product is intended to work. To date, only Adams Respiratory Therapeutics has obtained FDA approval for timed-release products containing guaifenesin (600 milligrams and 1200 milligrams) under the trade names of Mucinex and Humibid. These include over-the-counter products containing guaifenesin alone (Mucinex and Humibid), with the decongestant pseudoephedrine (Mucinex-D), and with the cough suppressant dextromethorphan (Mucinex-DM). Companies marketing unapproved products containing guaifenesin in timed-release form are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days. A small amount of these products is expected to be available after these dates until supplies are exhausted.

After these dates, companies wishing to market products containing guaifenesin in timed-release form that do not have the required FDA approval must obtain approval or face regulatory action. FDA is committed to working with companies to facilitate the process of ensuring that products are safe and effective, and meet appropriate standards for manufacturing and labeling. Today's action is part of FDA's broader initiative on marketed unapproved drugs that was launched in June 2006. At that time, the agency published a Compliance Policy Guide describing FDA's risk-based enforcement approach to unapproved drugs. The guidance explains that FDA intends to give priority to enforcement actions involving unapproved drugs with potential safety risks, that lack evidence of effectiveness and that constitute health fraud.