FDA Warns Against Internal Use of High-Strength Hydrogen Peroxide

Yael Waknine

Disclosures

July 28, 2006

July 28, 2006 -- The US Food and Drug Administration (FDA) has issued a health advisory to warn consumers against the purchase and ingestion of high-strength hydrogen peroxide products for medicinal purposes due to the risk for serious harm or death.

Consumers are advised to immediately discontinue use of these products, which include currently marketed items such as "35 Percent Food Grade Hydrogen Peroxide," and consult their healthcare provider, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

The high-strength hydrogen peroxide products are more than 10 times more concentrated than topical products used for disinfecting minor cuts. Ingestion of these highly corrosive products can cause gastrointestinal irritation or ulceration, and intravenous administration can result in blood vessel inflammation at the injection site, gas embolisms, and potentially life-threatening allergic reactions.

The FDA is currently working to stop companies from making illegal claims regarding their high-strength hydrogen peroxide products, because their ingestion is of no known clinical value and they have not been approved by the agency for any medical indications; moreover, their use can cause significant harm and lead to "tragic results."

To this end, warning letters have been issued to 2 firms selling 35% hydrogen peroxide products on the Internet for the treatment of AIDS, cancers, emphysema, and other serious and life-threatening diseases. The letters, dated 7/19/06, are available for viewing online at http://www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm .

Similar warnings previously issued to consumers include one from April 1989 that warned against the use of industrial-strength hydrogen peroxide illegally promoted for the treatment of AIDS and cancer; the alert followed a related death in Texas and several injuries requiring hospitalization.

Adverse events related to internal use of high-strength hydrogen peroxide should be reported to the FDA's MedWatch reporting program by phone 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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