Unapproved Lyme Disease Drug May Cause Fatal Poisoning

(as reported by Yael Waknine in Medscape 2006. © 2006 Medscape)

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 http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD