(CBS) — Millions of people are being given powerful antibiotics to treat common infections. Now, as Erin Kennedy reports, one safety advocate is warning that this may be overkill and wants the FDA to do something about it.
“I was a very healthy person at the time. I bicycled about seven to ten miles a day, I could bench-press 300 pounds,” said 54-year-old David Melvin from downstate Chatsworth, Illinois
Now, just helping his wife prepare a meal can be almost unbearable.
“I have days I can’t lift a half a gallon of milk, and if I do, I have to go lay down and rest for a while,” he said.
Melvin suffers from chronic fatigue, neuropathy and digestion problems – all due, he believes, to the antibiotic Levaquin, given to him for a common infection eight years ago.
“I don’t know what the future holds, whether I’ve got five years or I’ve got 15 years,” said Melvin.
Levaquin is in a class of drugs called fluoroquinolones.
These drugs already carry a black box warning for tendon ruptures, muscle weakness and central nervous system damage.
“It is powerful,” said Dr. Charles Bennett of the South Carolina College of Pharmacy.
He is one of the nation’s leading watchdogs for prescription drugs. He says the big problem with flouroquinolones is inappropriate use.
“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,” said Dr. Bennett.
He has filed two citizen’s petitions with the FDA.
One seeks to expand the black box warning to include mitochondrial toxicity, meaning damage can occur within a patient’s cells and possibly show up years later as Parkinson’s, Alzheimer’s or ALS in patients who may be more at risk.
“Potentially, a genetic predisposition to be a poor metabolizer of the drug, so it’s not what you take it for, it’s who you are,” explained Dr. Bennett.
The second petition wants to highlight the potential for serious psychiatric events.
“This is another one, if I am depressed,” said Caroline Eagan.
She took Levaquin eight years ago for a sinus infection and hasn’t been the same since.
“One day, I can be okay and focus and another day I can’t even talk to anybody because they are not making sense,” she said.
Melvin had to retire early from the Illinois State Police and now focuses on his blog dedicated to the Levaquin safety issue.
Through emails, people tell him: “the pain is almost unbearable,” and “I woke up one day in hell.”
So, what does he want to see happen to these drugs?
“I don’t think they need to be taken off the market but I think doctors and patients should be informed,” said Melvin.
For more information on fluoroquinolones, click here.
To see Dr. Charles Bennett’s citizen petition, visit www.saferpills.org/citizen-petition/.
David Melvin’s blog is at www.myquinstory.info/.
Janssen Pharmaceuticals, Inc. released a statement saying: “At Janssen, our first priority is the well-being of the people who use our medicines.
We are aware of the Citizen Petitions and we are evaluating them.
LEVAQUIN® (levofloxacin) is part of the important fluoroquinolone class of anti-infective prescription medications that have been used for more than 20 years to treat infections, including those that may be serious or life threatening. All medicines, including LEVAQUIN®, have both benefits and risks. We continually collect and monitor information on the safety and effectiveness of all our medicines, and, in cooperation with the US FDA and other health authorities, we incorporate new data into our product labels so doctors and patients can make informed decisions.
Ever since it was first approved by the FDA in 1996, the LEVAQUIN® label has provided information to physicians on the risks and benefits associated with the medication, including warnings and precautions.
Since 2004, the LEVAQUIN® label has informed physicians and patients about possible side effects related to peripheral neuropathy.”