Post by Admin on Jul 22, 2006 8:52:48 GMT -5
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA notified healthcare professionals and consumers not to use an injectable product called Bismacine, also known as Chromacine.
Bismacine is not a pharmaceutical and has not been approved to treat any condition, however, it is being prescribed or administered by doctors of "alternative health" to treat Lyme disease.
This product contains high amounts of bismuth, a heavy metal that is used in some medications taken by mouth to treat Helicobacter pylori, a bacteria that can cause stomach ulcers. Bismacine is not approved in any form for use by injection.
The FDA is investigating one report of death and several reports of injury related to the administration of Bismacine. Individuals who believe they have suffered adverse events from receiving Bismacine should seek medical attention. Possible effects of bismuth poisoning include cardio-vascular collapse and kidney failure.
Read the complete MedWatch 2006 Safety summary, including links to the FDA Press Release at:
www.fda.gov/medwatch/safety/2006/safety06.htm#Bismacin
Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process. They can learn more and subscribe to the e-list at www.fda.gov/medwatch.
FDA notified healthcare professionals and consumers not to use an injectable product called Bismacine, also known as Chromacine.
Bismacine is not a pharmaceutical and has not been approved to treat any condition, however, it is being prescribed or administered by doctors of "alternative health" to treat Lyme disease.
This product contains high amounts of bismuth, a heavy metal that is used in some medications taken by mouth to treat Helicobacter pylori, a bacteria that can cause stomach ulcers. Bismacine is not approved in any form for use by injection.
The FDA is investigating one report of death and several reports of injury related to the administration of Bismacine. Individuals who believe they have suffered adverse events from receiving Bismacine should seek medical attention. Possible effects of bismuth poisoning include cardio-vascular collapse and kidney failure.
Read the complete MedWatch 2006 Safety summary, including links to the FDA Press Release at:
www.fda.gov/medwatch/safety/2006/safety06.htm#Bismacin
Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process. They can learn more and subscribe to the e-list at www.fda.gov/medwatch.