Antibiotic leads to Tendon Ruptures; FDA Ignores Risks

[Guest guest]

Possibly of special interest to the Sports Medicine Specialists

Jan Patenaude

Antibiotic Leads to Tendon Ruptures; FDA Ignores Risks

Published on Thursday, January 03, 2008

by Healthy News Service

Back to _Healthy News_ (http://healthy.net/scr/HealthyNews.asp)

____________________________________

Public Citizen Sues FDA in Federal Court to Force Agency to Act On Petition

Seeking Stricter Fluoroquinolone Warnings

WASHINGTON, D.C. – Despite long-standing evidence that fluoroquinolone

antibiotics can cause tendon ruptures, the Food and Drug Administration (FDA)

has

failed to increase its warnings to patients and physicians about the dangers

of the medicines, Public Citizen told a federal court Thursday.

Public Citizen sued in the U.S. District Court for the District of Columbia,

asking the court to force the FDA to act upon a petition the consumer group

filed with the agency 16 months ago. The FDA has failed to respond to the

petition, which asked the agency to put a “black box†warning on

fluoroquinolone antibiotics (such as Cipro, Levaquin and others) to make

doctors and

patients more aware of the risk of serious tendon injury before tendons

actually

rupture.

The petition also urged the FDA to send a warning letter to physicians, as

well as require an FDA-approved medication guide to be dispensed when

prescriptions are filled. Public Citizen contends that the FDA is violating the

Administrative Procedure Act by not acting upon the petition.

Stronger warnings could lead to earlier intervention and prevent needless

injuries by allowing doctors to switch patients to other antibiotics, said Dr.

Sidney Wolfe, director of Public Citizen’s Health Research Group.

“While the FDA sits idly by and ignores the problem, more people will suffer

serious tendon ruptures that could have been prevented,†Wolfe said. “The

current warning is buried in a long list of possible adverse reactions and is

far too easy to miss.â€

From November 1997 through December 2005, the FDA received 262 reports of

tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274

cases of other tendon disorders in patients using fluoroquinolone

antibiotics. An additional 74 tendon ruptures have subsequently been reported

to the

FDA for a total of 336. Because only a small fraction of cases are typically

reported to the FDA, the actual number of ruptures and other tendon injuries

attributable to the antibiotic is much higher.

_READ_

(http://www.citizen.org/litigation/forms/cases/CaseDetails.cfm?cID=444) the

complaint.

Jan Patenaude, RD

Director of Medical Nutrition

Signet Diagnostic Corporation

(Mountain Time)

(toll free)

Fax:

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