" 

  
 ==Public Citizen / Flockhart / Cohen== 

  
 Public Citizen: 

 IN THE UNITED STATES DISTRICT COURT 
 FOR THE DISTRICT OF COLUMBIA 
 PUBLIC CITIZEN, INC. ) 
 1600 20th Street, NW ) 
 Washington, DC 20009 ) 
 (202) 588-1000 ) 
 ) 
 Plaintiff, ) 
 ) 
 v. ) C. A. No. ___________________ 
 ) 
 FOOD AND DRUG ADMINISTRATION ) 
 5600 Fishers Lane ) 
 Rockville, MD 20854 ) 
 (301) 827-2410 ) 
 ) 
 Defendant. ) 
 ______________________________________ ) 
 COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF 

 The FDCA, 28 U.S.C. § 331, prohibits the introduction into interstate commerce of any drug that is misbranded. A drug is misbranded unless its labeling bears adequate warnings. 28 U.S.C. § 352(f). 

 Tendinopathy and tendon rupture associated with fluoroquinolone antibiotics has been observed since at least 1988. Since that time, reports of fluoroquinolone-induced tendon injuries have appeared repeatedly in the medical literature. 

 From November 1997 through December 31, 2005, the FDA adverse event database received reports of 262 cases of tendon ruptures; 258 cases of tendinitis; and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. Because only a small fraction of adverse events typically are reported to FDA, the actual number of injuries attributable to fluoroquinolones is considerably higher. Analysis of the entire FDA adverse event database reveals that fluoroquinolones are implicated significantly more often in tendon ruptures than any other class of drugs. There has been no change in the rate of fluoroquinolone-induced tendon ruptures reported to FDA since December 31, 2005. From January 2006 through March 31, 2007, the FDA adverse event database received reports of 74 additional cases of tendon ruptures in patients using fluoroquinolone antibiotics for a total of 336 cases of tendon rupture reported since November 1997. 

 To date, FDA has not issued a decision on Public Citizen's petition, nor has it taken action to require adequate warnings of the risk of fluoroquinolone- induced tendinopathy and tendon rupture. Specifically, FDA has failed to require a black-box warning and enhanced provider information and, in addition, has failed to mandate an FDA-approved Medication Guide for patients. FDA has failed to act despite the significant and continuing reports to the agency of tendon injury linked to the use of fluoroquinolone antibiotics. 

 The considerable danger to public health occasioned by FDA's failure to require adequate warnings of the risk of fluoroquinolone-induced tendinopathy and tendon rupture counsels in favor of expeditious action on Public Citizen's petition. 

  

 PRESS RELEASE  Jan. 3, 2008 

 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 

 ""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."" 

 The FDA’s response to the Attorney General of the State of Illinois May 2005: 
 
 “I am writing to inform you that the Food and Drug Administration (FDA) has not yet resolved the issues raised in your Citizen Petition submitted  on May 24, 2005.   Your petition request that the Agency take the following actions  with  respect  to  the  entire  class of fluoroquinolone drug products and the potential adverse event of tendonopathy  and  tendon  rupture  to: 1)  revise  the  labeling  to  increase the warnings, 2)  provide ""BLACK   BOX""  warnings,  3)   require  manufacturers  to issue   ""DEAR HEALTH CARE PROFESSIONAL""  letter  that informs  these  professionals  of  the  potential  health  hazards  associated with the use of this class of drugs and  details  your  proposed  labeling  changes,  4)   supplement  information  provided to patients with bolded warnings,  and  5)  submit  the  issue  for review  and  analysis  to  FDA's  Drug Safety Oversight Board.  FDA  has  been  unable  to  reach  a  decision on your petition because it raises complex issues requiring extensive review and 
 analysis by Agency officials...” 

 Public Citizen recieved a similar response one year later. 

 Letter to the Food and Drug Administration to immediately ban the antibiotic trovafloxacin (Trovan). (HRG Publication #1485) 

 “With eight other drugs in the fluoroquinolone family already available in the U.S, as well as dozens of other safer and equally or more effective drugs for infections, the removal of TROVAN from the market will not deprive doctors or p