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Last updated on April 18, 2014 at 17:24 EDT

Illinois, group seek tougher Cipro tendon warning

August 29, 2006

LOS ANGELES (Reuters) – The group of antibiotics that
includes Bayer AG’s Cipro should carry “black box” warnings
about a higher risk of ruptured tendons, the Illinois Attorney
General and a consumer group told federal health regulators on
Tuesday.

The Illinois petition follows a request made in May 2005
that urged the U.S. Food and Drug Administration to require
manufacturers of the antibiotics to revise drug labels and
inform doctors of the risk.

Consumer group Public Citizen said its analysis of FDA
records from November 1997 to December 2005 on the class of
antibiotics known as fluoroquinolones found 262 cases of tendon
rupture, 258 cases of tendinitis and 274 cases of other tendon
disorders.

Bayer spokeswoman Staci Gouveia said the company had no
comment.

The pill form of Bayer’s Cipro has been available as
generic drug in the United States since 2004.

The FDA on Monday approved the first generic versions of an
injectable version of the drug.

The package inserts of all fluoroquinolones already include
a warning on the risk of tendinitis and tendon rupture.


Source: reuters