July 21, 2006 -- The FDA today warned consumers and health care providers not to use an unapproved product called "bismacine," also known as chromacine, that's sometimes used to treatLyme disease.
The FDA is investigating one report of a death and several reports of injury related to the administration of bismacine.
Bismacine is an injectable product that has been used to treat Lyme disease, which is a tick-borne bacterial infection. But bismacine is not approved for anything, including Lyme disease.
Bismacine is not a pharmaceutical and is mixed individually by druggists. It is prescribed or administered by doctors of "alternative health" or by people claiming to be medical doctors, according to the FDA.
Bismacine contains high amounts of bismuth, a heavy metal that is used in some medications taken by mouth to treat Helicobacter pylori, bacteria that can cause stomach ulcers. But bismuth is not approved in any form for use by injection.
The FDA reports that on April 20, 2006, one person died as a result of treatment with bismacine, and on March 29, 2005, another person was hospitalized after receiving a bismacine treatment.
"Other individuals who have used or been administered this product have also suffered serious adverse events. Possible effects of bismuth poisoning include cardiovascular collapse and kidney failure," states an FDA news release.
People who believe they have suffered adverse events from receiving bismacine "may wish to seek medical attention," states the FDA.
The FDA is evaluating the product's suppliers and pledges to take "additional action as appropriate." Meanwhile, the FDA asks that adverse reactions to bismacine be reported to the FDA's MedWatch adverse event reporting program by any of these methods:
- Internet: www.fda.gov/MedWatch/report.htm
- Phone: (800) FDA-1088 (800-332-1088)
- Fax: (800) FDA-0178 (800-332-0178)
- Mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Mailed reports should use postage-paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm.