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FDA Talk Paper

T05-23
May 20, 2005

Media Inquiries: Bradford Stone
                        301-827-6242
Consumer Inquiries: 888-INFO-FDA


FDA Warns Against Abuse of Dextromethorphan (DXM)

The Food and Drug Administration (FDA) is concerned about the abuse of dextromethorphan (DXM), a synthetically produced ingredient found in many over-the-counter (OTC) cough and cold remedies. The agency is working with other health and law enforcement authorities to address this serious issue and warn the public of potential harm, after five recently reported deaths of teenagers that may be associated with the consumption of powdered DXM sold in capsules.

Although DXM, when formulated properly and used in small amounts, can be safely used in cough suppressant medicines, abuse of the drug can cause death as well as other serious adverse events such as brain damage, seizure, loss of consciousness, and irregular heart beat.

DXM abuse, though not a new phenomenon, has developed into a disturbing new trend which involves the sale of pure DXM in powdered form. This pure DXM is often encapsulated by the “dealer” and offered for street use.

DXM has gradually replaced codeine as the most widely used cough suppressant in the United States . It is available OTC in capsule, liquid, liquid gelatin capsule, lozenge, and tablet forms. When ingested at recommended dosage levels, DXM is generally a safe and effective cough suppressant.

Additional information about the dangers of Dextromethorphan use and abuse can be found at the following SAMHSA National Clearinghouse for Alcohol and Drug Information links. http://store.health.org/catalog/mediaDetails.aspx?ID=371, http://www.family.samhsa.gov/get/otcdrugs.aspx.

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