Madigan seeks Cipro warning - Tendon damage risk seen from antibiotics

Madigan seeks Cipro warning - Tendon damage risk seen from antibiotics
By Bruce Japsen, Tribune staff reporter.
Bloomberg News contributed to this story
Copyright © 2006, Chicago Tribune
Published August 30, 2006


A prominent consumer group and Illinois Atty. Gen. Lisa Madigan Tuesday called for the government to put its strongest warning label on Cipro and similar prescription antibiotics because of a possible risk of tendon damage.

Public Citizen and Madigan said these antibiotics, known as fluoroquinolones, should be labeled with the Food and Drug Administration's stiffest so-called "black box" warning, which outlines the risks in boldface type that is outlined in a black box.

The warning would describe the drugs' link to torn tendons and other problems of tissue that joins the muscle to the bone. Public Citizen said the tendon that most frequently erupts is the Achilles tendon, which, when damaged, can cause severe pain and difficulty walking, among other problems.

"The numbers are startling," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

"Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics. The FDA must act and require black box warnings and patient information guides."

Public Citizen said its review of the FDA's database of adverse events associated with fluoroquinoline antibiotics showed 262 reported cases of tendon ruptures, 258 cases of tendinitis and 274 cases of other tendon disorders between November 1997 and Dec. 31, 2005.

The drugs are widely used, marketed in both generic and brand versions by at least 20 companies, according to the FDA. Bayer AG, the maker of Cipro, had no comment.

FDA spokeswoman Susan Bro said the "association of tendon rupture risk with fluoroquinolones in fact is well documented and understood by clinicians." She would not comment, however, on the status of the FDA's evaluation of the petitions by Madigan and Public Citizen or whether the agency plans to issue more serious warnings for the antibiotics.

Madigan asked the FDA to inform doctors about the drugs' risks and urged that the entire class of drugs be submitted to the FDA's Drug Safety Oversight Board for review.

While it is unusual for Madigan's office to push the FDA for enhanced warnings on prescription drugs, her health-care staff said they felt compelled to become involved after receiving complaints from Illinois consumers.

Madigan then decided to join with Public Citizen after receiving "only a tentative, non-substantive response," from the FDA in November of 2005.

Since then the FDA has "never responded substantively to the petition," Madigan's office said in a statement, so the attorney general decided to join forces with Public Citizen in urging the agency to slap black box warnings on the antibiotics.