FDA Warns Public of OTC Dextromethorphan Abuse

Yael Waknine

Disclosures

May 24, 2005

May 24, 2005 -- The U.S. Food and Drug Administration (FDA) has notified the public via a talk paper of its concerns regarding the potential abuse of dextromethorphan, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting system.

The warning follows recent reports of five teenage deaths that may be associated with the consumption of powdered dextromethorphan sold in capsules.

Dextromethorphan is a synthetically produced ingredient that is included in many over-the-counter (OTC) cough and cold medications. It is available in capsule, liquid, liquid gelatin capsule, lozenge, and tablet forms at stores and on the Internet.

Although dextromethorphan is a safe and effective cough suppressant when used in small quantities as directed, its abuse to get a "'high"' can cause serious adverse events such as brain damage, seizure, loss of consciousness, arrhythmias, and death.

According to the FDA, dextromethorphan abuse is an old phenomenon with a new and disturbing twist -- the sale of pure dextromethorphan in powdered form, often encapsulated by the "dealer" and offered for street use.

Parents are advised to watch their children for signs of abuse of dextromethorphan or other OTC drugs, including use of large amounts of cough or cold remedies or use when their children are not ill; disappearance of products from the medicine cabinet; and medication stashes found in the child's room or backpack. Falling grades, mood swings, and changes in normal habits or appearance can also be potential signs of drug abuse.

The FDA is working with other health and law enforcement authorities to address the issue of dextromethorphan abuse and warn the public of potential harm. Additional information regarding the dangers of dextromethorphan 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, and http://www.family.samhsa.gov/get/otcdrugs.aspx.

Adverse events related to the use of dextromethorphan should be reported to the FDA's MedWatch program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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