Studies: Fluoroquinolones could cause nerve damage
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 fluoroquinolones 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.