FDA evaluates antibiotic that patients say makes them sicker - KCTV5

It is an antibiotic powerful enough to kill anthrax or the plague, but it is being prescribed for simple infections like sinusitis and urinary tract infections.

One group wants the Food and Drug Administration to reach beyond a black box warning issued in 2008 for Levaquin after an internal FDA report showed possible links between the drug and debilitating diseases like ALS, Alzheimer's and Parkinson's.

"We're talking about a possible drain on future healthcare costs," Linda Martin, of Arizona, told KCTV5 News in a phone interview.

Martin took Levaquin three times for sinus infections. She is now an outspoken critic of the drug, helping file a citizen petition last year calling for better labeling by the FDA. Click here to read the petition.

Levaquin is an antibiotic known as a "quinolone" or "fluoroquinolone." Other brand names include Cipro, Avelox and Levofloaxcin.

"It's a good antibiotic for infections in many different organ systems in many parts of the body, so it's very widely used over the last 20 years," said chief medical officer Dr. Lee Norman at the University of Kansas Hospital.

The FDA issued a black box warning in 2008, a serious red flag meant for doctors to note before prescribing quinolones to their patients. The warning came after the FDA discovered Levaquin to cause tendonitis and tendon tears.

But people like Chris Butler of Raymore say their doctor doled out the medicine three to four times a year for sinus infections well after the black box warning surfaced.

"It makes me angry. It is hard for me to even express just how angry I am. Because I feel doctors, pharmacists, medical practitioners should know about black box warning on drugs," Butler said.

Butler underwent four tendon tear surgeries and started experiencing neurological disorders before he launched his own investigation into Levaquin. It wasn't until 10 years after his first Levaquin prescription, he figured out, he had been taking a drug known to cause such injuries.

In 2013, the FDA started warning users of peripheral neuropathy, neurological diseases that can lead to tingling and pain in the limbs. Butler also knows those symptoms well.

"Even to this day I will have shooting pains in my hands and my feet. My hands will go numb, my feet will go numb," Butler said.

But what hasn't been disclosed is a condition called "mitochondrial toxicity" detailed in the 2013 internal FDA report. It is a condition that can lead to lasting neurodegenerative diseases.

"Mitochondria are the little organs inside each cell that are basically power plants that generates the cell," Norman said.

Research in non-human mammals showed quinolones can cause the weakening of those cells.

Martin and the citizen petition wants these possible serious side effects to be on all warning labels for antibiotics like Levaquin.

The FDA told KCTV5 it is not ready to respond to the request.

The group has also shared the information with lawmakers on the U.S. Senate Health Committee which includes Kansas Sen. Pat Roberts. He did not return our messages for comment.

"I trusted my doctors to do what's best for me. And when I realize when I couldn't trust them to warn me about the drugs, it was my responsibility," Butler said.

Butler is not taking legal action against his doctors or the drug company. He says his sole purpose in speaking out is to raise awareness about taking prescription pills like Levaquin.

"It's being used for things like sinus infections. For women, UTI's is this drug appropriate for those situations?" Butler asked.

Norman doesn't believe quinolones should be taken off the market. He says these kinds of antibiotics save lives but consumers need to ask more questions and do research before popping a pill.

"Does every doctor know about every single product and every line of the package insert? No. I can assure you, no," Norman said, "I really think it's important people ask questions."

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