A reported 100,000 Americans, including a 54-year-old Illinois man and 36-year-old North Carolina woman, have reported severe side effects from Levaquin, an antibiotic that packs enough pill power to kill anthrax.
Levaquin, a drug classified in the fluoroquinolone family, is now undergoing another Food and Drug Administration evaluation because of the controversy.
Twelve years after approving it in 1996, the FDA sent out a black-box warning upon learning the drug caused tendonitis. The warning was a red flag for doctors to take pause prior to prescribing it to patients. In 2013, an agency communication “required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy.”
Apparently, the man’s healthcare professional didn’t get the messages. Eight years ago, he started taking Levaquin and since has developed neuropathy.
“I was a very healthy person at the time,” the man told CBS Chicago. “I bicycled about seven to ten miles a day, I could bench-press 300 pounds.”
He said he had no choice but to retire early from the force because “the pain is almost unbearable.”
The 36-year-old North Carolina woman also reported being in unbearable pain following a regimen of Levaquin during the summer of 2014. She undergoes physical therapy every week to help with her tendinopathy.
“Every day you push through it, you push through it because you have to,” she told an NBC affiliate in Washington. “It’s very painful for me, just because my Achilles hurts really bad. So in order for me to not lose strength in my legs, I have to do this. I just have to bear the pain.”
Both were given Levaquin to treat common infections. South Carolina Dr. Charles Bennett said their diagnoses are unfortunate but commonplace.
“I’m not surprised,” Bennett said. “I’ve been working on this for years. This… is a story that’s replicated in city after city, case after case.”
That’s why he filed a pair of petitions with the FDA calling for the agency to re-issue the black-box warning to include another side effect – mitochondrial toxicity, a condition that can lead to ALS, as well as Alzheimer’s and Parkinson’s disease. The petitions also point to the possibility of psychiatric-related side effects.
“We are talking about going into the physician’s office, having a little sniffle, walking out with an antibiotic and shortly after having these kinds of problems,” Bennett said.
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, manufactures Levaquin.
The best advice for patients is to talk with their doctors and/or pharmacists about the side effects a reported 100,000 Americans are experiencing.