Unapproved Lyme disease treatment harmful, FDA warns

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It makes me wonder if this is an overreaction , we all want safe drugs , but is there such a thing? Bismuth is effective against HP taken as an oral compound .Anyone had any experience of this ..

http://www.cnn.com/2006/HEALTH/07/21/lyme.disease.reut/index.htmlUnapproved Lyme disease treatment harmful, FDA warnsWASHINGTON (Reuters) -- An unapproved compound mixed by pharmacists to treatLyme disease should not be used, U.S. health officials warned Friday, afterone person died and another was hospitalized earlier this year.The Food and Drug Administration said other users of the compound, calledbismacine, have reported severe side effects that can include kidney failureand cardiovascular collapse.The agency said it was investigating all reported cases but did not say howmany people had reported problems.Bismacine, also known as chromocine, contains large amounts of the metalbismuth, used in some medications to treat ulcer-causing bacteria, accordingto the FDA.In March, one person was hospitalized after receiving the compound. InApril, another person died from the treatment, the agency said.Some doctors have been known to administer the injectable solution to treatthe disease, which is caused by bacteria often spread by tick bites; ifuntreated, Lyme can affect the nervous system, joints and heart. Some stateshave already taken legal action against such physicians.The FDA said it was evaluating those who supply the compound. Anyone who hastaken the product and is concerned about side effects may want to seekmedical care, it added.Copyright 2006 Reuters.=====http://www.webmd.com/content/article/125/115962.htmFDA: Lyme Disease Compound RiskyBismacine, an Unapproved Compound, Linked to 1 Death By Miranda HittiWebMD Medical News Reviewed By Louise Chang, MDon Friday, July 21, 2006July 21, 2006 -- The FDA today warned consumers and health care providersnot to use an unapproved product called "bismacine," also known aschromacine, that's sometimes used to treat Lyme diseaseLyme disease.The FDA is investigating one report of a death and several reports of injuryrelated 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 foranything, including Lyme disease.Bismacine is not a pharmaceutical and is mixed individually by druggists. Itis prescribed or administered by doctors of "alternative health" or bypeople claiming to be medical doctors, according to the FDA.Bismacine contains high amounts of bismuth, a heavy metal that is used insome medications taken by mouth to treat Helicobacter pylori, bacteria thatcan cause stomach ulcersulcers. But bismuth is not approved in any form foruse by injection.The FDA reports that on April 20, 2006, one person died as a result oftreatment with bismacine, and on March 29, 2005, another person washospitalized after receiving a bismacine treatment."Other individuals who have used or been administered this product have alsosuffered serious adverse events. Possible effects of bismuth poisoninginclude cardiovascular collapse and kidney failurekidney failure," states anFDA news release.People who believe they have suffered adverse events from receivingbismacine "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 adversereactions to bismacine be reported to the FDA's MedWatch adverse eventreporting program by any of these methods:a.. Internet: www.fda.gov/MedWatch/report.htmb.. Phone: (800) FDA-1088 (800-332-1088)c.. Fax: (800) FDA-0178 (800-332-0178)d.. Mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787Mailed reports should use postage-paid FDA form 3500, which may bedownloaded from www.fda.gov/MedWatch/getforms.htm.----------------------------------------------------------SOURCES: News release, FDA. WebMD Medical Reference in collaboration withThe Cleveland Clinic: "Arthritis: Lyme Disease."© 2006 WebMD Inc.