FDA not disclosing serious Levaquin side effect

Posted at 6:31 PM, Sep 16, 2015
and last updated 2015-09-16 18:31:44-04
Each year, millions of people take a class of antibiotics called fluoroquinolones. Doctors commonly prescribe the powerful drugs to treat infections. But a growing chorus of people who've taken them say they were not properly informed of a potentially debilitating side effect.
They're part of an active online community who call themselves floxies-- people who've been seriously and sometimes permanently damaged by fluoroquinolones. Our In Focus investigation found the Food and Drug Administration (FDA) is aware of a potentially crippling side effect called mitochondrial toxicity, but has yet to act on it.
"It has destroyed my life. It has shattered my life," said Terry Aston of Baltimore. "I don't have a life. I'm existing right now." 
Aston's life is completely different than it used to be. The former truck driver spent long stretches on the road, away from home. Now, it's difficult for her to leave her house at all.
"I'm tired all the time. I have to really push to get anything done," she said. "I have pain everyday, all day throughout my body."
She blames fluoroquinolones-- antibiotics approved to treat very serious infections, like pneumonia. They're known under brand names Levaquin, Cipro and Avelox. Aston said she was first prescribed Cipro in 1991 and didn't link her bizarre symptoms to the drugs at first. She continued taking them when prescribed by her doctor, ignoring her burning feet, muscle weakness, vision problems and fatigue. Twenty years later, she finally made the connection after taking Levaquin for the last time. 
"I had lost all of my neck muscles and my neck would keep dropping," she said. "I had no control over my neck, and I was having a very difficult time walking. When it happened again in 2011, that's when I kind of put it together."
Aston's symptoms are consistent with mitochondrial toxicity--a serious condition that can weaken the entire body and is linked to neurodegenerative diseases like Parkinson's, Alzheimer's and ALS.
"I look at mitochondria as like the gas tank. The mitochondria are sort of like the energy supply for us to work, so when you get mitochondrial toxicity, you're basically running on empty," said Dr. Charles Bennett, who chairs the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina. 
He filed a citizen petition last June urging the FDA to add a black box warning-- the strongest required by the agency-- to Levaquin's label for possible mitochondrial toxicity.
"Black Box warning, make it clear, the side effects of the drug are this, if patients get sick, they understand what is happening," Dr. Bennett said. "Patients, also ask your doctors upfront, 'Do I really need that medication?'" 
Dr. Bennett said fluoroquinolones are useful drugs--so powerful they're used to treat people exposed to anthrax. But he stressed they should only be used to treat the most serious infections.
"Cipro and Levaquin, are two of the most commonly over prescribed medications we have," he said. "They're very strong, no doubt about it, but they can have tremendous, they can have side effects that can really affect patients for a long time."
"We want doctors to just stop handing these drugs out like candy," said Dee Jump of Harwood, Md. "We want patients to be warned." 
Jump became an advocate for the additional Black Box warning after she was prescribed the generic Levofloxacin for a UTI.  Once a very active person, she experienced crippling side effects after taking the antibiotic for three days.
"There was one hour where I walked outside healthy and it's like a bomb went off in my body and every cell was changed in my body," she said. "You could feel that something happened."
A laundry list of troubling symptoms followed.
"Connective tissue damage, problems to my central nervous system, problems to my nerves," Jump said. "My eyesight comes and goes sometimes, some blurring. I sometimes have some numbness in my face and my lips." 
After months of suffering, Jump was able to find some relief through a physiatrist, a nerve, muscle and bone expert, who has experience treating patients dealing with fluoroquinolone side effects.
"I live with some pain everyday, but I feel like I'm one of the fortunate ones that I have recovered as much as I have," she said. "New little symptoms pop up here and there, but it's a level I can live with."
A 2013 FDA report obtained by ABC2 In Focus raised concerns about mitochondrial toxicity from exposure to fluoroquinolones. But more than two years later, still no action.
"We want it out there and we're not going away until we get change," Aston said. "These are serious drugs with serious side effects."
ABC2 In Focus reached out to the FDA to get a status update on Dr. Bennett's petition. Spokeswoman Lyndsay Meyer wrote that the agency is not able to discuss the contents of the petition because it's still under review. But she went on to say that the FDA "takes concerns about the safety of approved drugs very seriously" and is giving the concerns raised in the petition "careful attention."
A previous citizen petition to add a Black Box warning for another Levaquin side effect was successful. In 2008, the FDA announced it would add a Black Box warning for an increased risk of tendonitis and ruptured tendons.