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Consumer Update |
On May 25, 2007, FDA announced that it will take action against companies that market unapproved drug products in timed-release dosage form that contain guaifenesin.
About 20 firms make timed-release products containing guaifenesin that have not undergone FDA review. As a result, they are considered by FDA to be unapproved drugs.
Guaifenesin is a substance commonly used in medicines to relieve cough and cold symptoms by stimulating the removal of mucous from the lungs. It is used in both prescription and over-the-counter medicines.
Timed-release products release their active ingredients over an extended period of time, reducing the number of doses needed per day. Other names for timed-release are extended-release, long-acting, or sustained-release.
FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled.
For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.
The unapproved products include timed-release forms of products that contain only guaifenesin and those that contain guaifenesin combined with other active ingredients. These products may be prescription or over-the-counter medicines.
Some of the biggest sellers of these products, marketed under trade names, are:
Yes. There are many legally marketed, over-the-counter products containing guaifenesin in immediate release form. Immediate release guaifenesin products will remain on the market.
In addition, one company, Adams Respiratory Therapeutics, has obtained FDA approval for timed-release products containing guaifenesin. The approved time-released products include the following over-the-counter drugs:
Previously manufactured unapproved timed-release guaifenesin products may still be found on pharmacy shelves and in consumers' homes for a short period of time.
Manufacturers must stop making these products by Aug. 27, 2007, and stop shipping the products in interstate commerce by Nov. 25, 2007. A small amount of these products is expected to be available after these dates until supplies are exhausted.
Consumers should talk to their health care provider about whether or not to use an unapproved guaifenesin-containing timed-release product.
For more information on timed-release drug products containing guaifenesin:
www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#guaifenesin
Date Posted: May 31, 2007
