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Antibiotic Leads to Tendon Ruptures; FDA Ignores Risks
 
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Published: 16 y
 

Antibiotic Leads to Tendon Ruptures; FDA Ignores Risks


Public Citizen Sues FDA in Federal Court to Force Agency to Act On Petition Seeking Stricter Fluoroquinolone Warnings


Published on Thursday, January 03, 2008
by Healthy News Service

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.”

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 the complaint.


Provided by Public Citizen on 1/3/2008

Note:  Yet another instance of the FDA protecting the profits of the pharmaceutical industry at the expense of the health of the public it is supposed to serve by ignoring the dangers of a patented and highly profitable drug.  Shades of Vioxx, Celebrex, Alleve, Gardasil, Fosamax, etc.  One can only imagine the FDA's reaction if 336 tendon ruptures had been reported for those who take the best antibotic and pathogen destroyer on the planet - colloidal silver.  No doubt, they would have raided the manufacturer with storm troopers and shut it down years ago.

The differences in how the FDA treats patented drugs as opposed to natural supplements is, in my humble opinion, starkly telling.  A patented drug with proven instances of harm associated with it's use does not even warrant a consumer warning.  On the other hand, a natural alternative, and thus a threat to the profits of the approved drug, such as colloidal silver, is singled out for enforcement action despite virtually no consumer complaints at all - and the media is regularly fed new rounds of bogus scare stories about "blue people" (the blue skin condition known as argyria) to scare the public and justify enforcement actions.

Although as far as I can tell, not one single instance of argyria has been attributed to properly made colloidal silver (instead, the rare handful of instances of argyria, have been associated with silver nitrate products, homemade silver where salt was used, or silver which was made using animal protein to form a suspension and mistakenly call it a colloid), that has not stopped the FDA from continuing to "sing the blues" about silver or from going after those who make and sell colloidal silver products, not, in my strong opinion, because silver represents a whit of threat to human health but rather because it represents a threat to the inflated bottom line profits of the mainstream drug manufacturers.

Zealous protection of mainstream approved drugs and suppression of natural competition is nothing new - look at the estimated 100,000 or more deaths caused by Vioxx before the FDA finally removed it from the market.  Look at the ridiculous actions of the FDA when it threatened Washington cherry growers for telling the truth about the health benefits of eating cherries, or at the storm trooper actions against the makers of charantia (bitter melon) tea in Florida who dared put references to some of the 650 plus PubMed studies and citations about bitter melon on their website.

A prime example of such selective enforcement is the continued persecution of CureZone sponsor Utopia Silver, who was been singled out as a special test case for FDA actions against colloidal silver despite the lack of a single consumer complaint.


Finding out who the FDA really serves is a simple task - all you have to do is follow the money.

"The FDA 'protects' the big drug companies and are subsequently rewarded, and using the government's police powers they attack those who threaten the big drug companies. People think that the FDA is protecting them.

It isn't.

What the FDA is doing and what the public thinks it is doing are as different as night and day."

Dr. Herbert Ley
Former U.S. FDA Commissioner

DQ

 
 

 
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