From: unk...@googlegroups.com   
      
   Patients, experts: Popular antibiotics could cause permanent damage    
   Studies: Fluoroquinolones could cause nerve damage    
      
   ABC15 Investigators , Cristin Severance    
   6:12 AM, Nov 24, 2014    
   6:44 PM, Nov 25, 2014    
      
   Autoplay:    
   KGTV SHOW    
      
   SAN DIEGO - For Jenny Frank, it started with a small white pill she took   
   nearly four years ago.    
      
   "I was prescribed Levaquin for a strep infection," she said. "I can't compare   
   myself to the person I was in December in 2010."    
      
   Levaquin is one of the most commonly prescribed antibiotics on the market.   
   Frank said it left her with persistent, painful and long-term side effects   
   that affected her both physically and mentally.    
      
   She recalls one moment as the scariest of her life.    
      
   "About three weeks after I had stopped taking it, I started typing on the   
   computer," Frank said. "When I looked at what I had written it wasn't even   
   words."    
      
   The science teacher said it was "gibberish."    
      
   So, Frank deleted what she wrote and tried again.    
      
   "Same thing... it was just random letters and numbers and things," she said.    
      
   When asked what she was thinking, Frank said, "I can't even put a sentence   
   together. Oh my god. Am I going to lose my job?"    
      
   New warnings needed?    
      
   Levaquin is in a class of antibiotics called fluoroquinolones.    
      
   It is one of the most potent antibiotics approved by the Food and Drug   
   Administration and is prescribed millions of times a year. Experts said that   
   most Americans will take Levaquin in their lifetime.    
      
   Team 10's investigative partners at ABC 15 in Phoenix spoke to researchers and   
   patients across the country who believe that Levaquin carries more serious   
   side effects than are listed on the label. They have filed a pair of citizen   
   petitions this year    
   asking the FDA to add new warnings to the label for a long list of psychiatric   
   side effects ranging from depression to hallucinations and also something   
   called "mitochondrial toxicity."    
      
   In simple terms, researchers say that means it could alter and damage the   
   body's cells.    
      
   Dr. Charles Bennett helped write the citizen petitions filed with the FDA.   
   Bennett, who says he has successfully petitioned the FDA before, is with the   
   South Carolina College of Pharmacy and the Southern Network on Adverse   
   Reactions (SONAR).    
      
   He said he has been analyzing the effects of Levaquin and other    
   luoroquinolones for three years.    
      
   Bennett said thousands of people have reported psychiatric side effects to the   
   FDA. He also pointed to a 2013 FDA review of six different fluoroquinoles,   
   including Levaquin, that raised the possibility of mitochondrial toxicity.    
      
   Team 10 has also learned that full studies are underway at UC San Diego and   
   the University of Rochester to look into these side effects.    
      
   Experts: Overuse leads to added risk    
      
   Frank is part of the fight to add new warnings to the label.    
      
   "There's no reason why anyone should have to go through this if there are   
   safer antibiotics that could be used," she said. "This should be a last   
   resort. Not a first line of defense."    
      
   It is a feeling shared by Dr. Ray Woosley, founder of CredibleMeds and a   
   medication safety expert. He believes Levaquin and other fluoroquinolones are   
   overprescribed.    
      
   "The FDA put out a call two years ago that says don't overuse these drugs, but   
   they continue to be overused," Woosley said. "It's like the wild west out   
   there."    
      
   Here is an example: During the anthrax mail attacks in 2001, victims were   
   prescribed the fluoroquinolone Ciprofloxacin.    
      
   "They are very potent antibiotics," Woosley said. "We can't take them off the   
   market. We have got to have them available for whom they are lifesaving."    
      
   But Woosley said that is also why these antibiotics should not be prescribed   
   for things like sinus infections or prostatitis, like Tony Woods.    
      
   Woods was prescribed Ciprofloxacin for a possible prostate infection two years   
   ago.    
      
   "There was no evidence I had an infection," said Woods, "He just wanted to   
   treat me for what he thought was an infection."    
      
   Woods took the pills for 19 days.    
      
   "I started having extreme burning in my limbs, sensitivity to light, my eyes,   
   my hearing, everything just felt rearranged," he said. "I couldn't smell or   
   taste."    
      
   The father of four was bedridden for months.    
      
   "It's horrible," Woods said. "You go to bed thinking you are going to die ...   
   who's going to provide for my family?"    
      
   Woods' attorney, John Fiske, said his firm, John Gomez Trial Attorneys, has   
   been getting hundreds of calls a week from people who have taken these drugs.    
      
   Fiske said the maker of Levaquin, Johnson & Johnson, faces a product liability   
   lawsuit over side effects of the drug that allegedly caused peripheral   
   neuropathy for one woman.    
      
   The complaint was filed in August in the U.S. District Court for the Northern   
   District of California. Fiske expects more to be filed against the makers of   
   these drugs.    
      
   "These are some of the most widely prescribed drugs in the world," said Fiske.    
      
   Last year, the FDA added a warning to fluoroquinolone labels for nerve damage.   
   In 2008, the FDA forced a black box warning because it can cause tendons to   
   snap. A black box warning is the highest action the FDA can take before   
   pulling a medication off    
   the market.    
      
   "Most people, if they knew it could have affected them, they wouldn't have   
   taken it," said Woosley.    
      
   Just ask Frank. She took eight of the 10 pills of her Levaquin prescription.   
   She said every dose is one of regret.    
      
   "If someone said to me that you could go back in time and change one thing, I   
   would not fill this prescription and take these pills," she said.    
      
   FDA and Levaquin respond    
      
   A representative for the FDA sent the following statement:    
      
   "We have received the citizen petition and will respond directly to the   
   petitioner after we review. The citizen petition and any comments on it can be   
   found here: http://www.regulations.gov/#!docketDetail;D=FDA-2014-P-0856.    
      
   We like to view drug labels as living documents. We work with companies to   
   regularly update them as new safety or efficacy."    
      
   Bayer responds    
      
   Team 10 also reached out to the maker of Ciprofloxacin for a comment and is   
   waiting to hear back.    
      
      
   http://www.10news.com/news/investigations/patients-experts-popul   
   r-antibiotics-could-cause-permanent-damage-11242014   
      
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