CHARLOTTE, N.C. - Some patients and doctors are blaming popular antibiotics for devastating side effects, including ALS/ Lou Gehrig's disease, Alzheimer's disease, Parkinson's disease, and even death.
These kind of antibiotics are called "fluoroquinolones." They're prescribed for a variety of serious bacterial infections. Some of the more well-known generics include Ciprofloxacin and Levofloxacin, and the brand name examples include Cipro and Levaquin.
Donna Versace said she was fine until she got a urinary tract infection, took Ciprofloxacin, and started having odd side effects.
"All of the joints in my body started popping," she said.
She admits she can't prove the drug is to blame. But, she says, she never had trouble standing before. Now, she needs a cane and usually ends up on the sofa. Versace says it's been hard to keep a job, or even friends, because she just can't keep up.
"It's ruined [my life]. I can't go anywhere. I lay on my couch, with pain every single day that is so bad it feels like somebody's ripping flesh right off my bones," Donna Versace said.
That may sound far-fetched, but she's not alone. A Georgia man's wife says he was in great shape, got sick, went to urgent care, and got a prescription for Levofloxacin. Kathy Dannelly says he took just two pills and, days later, he was dead. "That's really hard to get out of my mind," she said.
Jeff Stephens says he had a sinus infection, took seven doses of the same medicine, and ended up hobbling around. "I may be one of those that's crippled for the rest of my life. It's terrifying," he said. Just weeks before, he says he was running on a beach in Australia and that he has home video of it.
SC doctor asks feds to require more warnings
Dr. Charles Bennett thinks there are many more examples. He runs, he said, the largest drug safety program in the country, which happens to be in South Carolina.
He's an oncologist, tied to the University of South Carolina, South Carolina College of Pharmacy and Medical University of South Carolina. He says his group has an $8 million budget to investigate medicines with adverse side effects.
He said his group gathered "thousands" of stories from people who reported these side effects from those drugs -- click here to read more on the warnings:
- Muscle weakness
- Heart disease
- Hearing loss
- Nerve damage
"Some of these side effects occurred after two or three doses of drug. Some of them occurred with re-challenge: every time you took the drug again, you got sick again. Some of the side effects: never resolved," he said.
But Bennett is clear: These antibiotics can be very effective, so he doesn't want them banned. He just wants the federal government to do more to warn patients about possible side effects.
In 2013, the FDA did require labels on these kinds of antibiotics to mention possible "permanent nerve damage."
Still, Bennett is petitioning the FDA to require even stronger warnings on these drugs. He said, so far, the agency hasn't responded.
So, now, he's asking Congress to step in and force the FDA's hand. "Because I think, if we get the grassroots from the Congress, the Senate, we're going to get it turned over," he said.
Senators on the health committee, like North Carolina's Richard Burr, may be hard to convince.
"I'm not sure that the American people want non-healthcare professionals trying to drive decisions about medications and their approval or rejection," he said.
Bennett also believes it's an uphill battle because these antibiotics, he says, generate more than $2 billion in sales each year.
Drug company response
A dozen companies make these drugs, including the generics and the brand names.
The company behind Levaquin, Janssen Pharmaceuticals, told Action 9, "Our first priority is the well-being of the people who use our medicines. We are aware of the [Dr. Bennett's] Citizen Petition and are evaluating it. 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 U.S. 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."
You can find the current Levaquin Medication Guide here, and the full U.S. prescribing information, including boxed warning, here.
If you have negative side effects from fluoroquinolones, tell your doctor. If you feel the warnings should be stricter, tell your federal lawmaker.
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