Unapproved Lyme Disease Drug May Cause
(as reported by Yael Waknine in Medscape 2006. © 2006
July 21, 2006 — The US Food and Drug
Administration (FDA) has warned consumers and health care providers via health
advisory against the use of bismacine injection (also known as chromacine) due
to the risk for potentially fatal bismuth poisoning.
According to the FDA, the product has been used to treat Lyme
disease and contains high amounts of bismuth, which is not indicated for
injection in any form.
Use of bismacine has been linked to the death of 1 patient in
April 2006 and the hospitalization of another in March 2005. Other individuals
given the injection have also suffered serious adverse events related to bismuth
poisoning, which can include cardiovascular collapse and renal failure.
The FDA emphasizes that the product is not a pharmaceutical
and has not been approved by the agency for any indication. Mixed individually
by druggists, bismacine injection is prescribed or administered by alternative
health physicians and those claiming to be doctors.
Patients with concerns regarding adverse events potentially
related to bismacine injection may wish to seek medical attention.
Health care professionals are encouraged
to report bismacine-related adverse events to the FDA's MedWatch reporting
program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at
, or by mail to 5600 Fishers Lane,
Reviewed by Gary D. Vogin, MD