Tendon issues with Ab'sl?

[Guest guest]

I saw this come across another list that I belong to and was

wondering if anyone had heard anything about it?

Group Sues FDA for Stronger

Warnings

Jan 3, 7:16 PM (ET)

WASHINGTON (AP) - A consumer

group sued the Food and Drug Administration Thursday, charging the agency is

ignoring calls for stronger warnings that Cipro and similar antibiotics may

cause serious tendon injuries.

Labels of the

fluoroquinolone family of antibiotics - drugs that include the popular Cipro

and Levaquin - already warn about rupture of tendons and other tendon injuries,

but at the bottom of a list of other side effects.

The consumer group Public

Citizen wants those warnings upgraded to the FDA's most severe type, a

so-called black-box warning - and for patients to get pamphlets with every

bottle that describe the risk. It argues that too few patients know they're

supposed to quit using the drugs if they experience symptoms such as pain or

inflammation, before the tendon actually ruptures.

Public Citizen filed a

petition seeking the stronger warning in August 2006.

The state of Illinois had filed a

similar petition the previous year.

The FDA is violating its own

statutes and putting patients at risk in taking so long to settle the issue,

Public Citizen said in the suit filed in U.S.

District Court for the District of Columbia.

When Public Citizen first

filed the petition, FDA's database showed 262 reports of tendon ruptures

between November 1997 and December 2005, along with hundreds of other tendon

problems in users of these antibiotics. Since then, the FDA has received an

additional 74 reports of tendon ruptures, said Public Citizen's Dr. Sidney

Wolfe. Only a fraction of drug side effects typically are reported to the

agency, he noted.

An FDA spokesman said the

agency was evaluating the lawsuit and declined comment.