DENVER — Some of the most popular medications prescribed to treat bacterial infections can cause serious side effects and are being over-prescribed, according to studies and reports.
The Food and Drug Administration has said Cipro (ciprofloxacin), Ofloxacin, and Levaquin (levofloxacin) — prescription drugs known as fluoroquinolones — can have rare but serious side effects. These side effects include tendon rupture, neuropathy, central nervous system impacts, and suicide.
“It destroyed my life,” said Jon Horne, who was prescribed Ofloxacin.
Horne lives in Aurora and says her doctor prescribed Ofloxacin to treat a stomach infection while on vacation with her family.
“I took the pills and I just don’t know, I went completely psychotic,” he said.
Horne has been diagnosed with neuropathy, which leaves him in chronic pain.
“I get burned alive and get stung by bees and I have Charlie horses all the time,” he said.
Horne says he doesn’t believe he was properly warned of the risks by the doctors who prescribed him the drugs.
Dr. Tim Jenkins, an infectious disease physician at Denver Health, was part of a panel of experts from the Center for Disease Control and Prevention investigate overuse of antibiotics such as fluoroquinolones. The study found that 47% of fluroquinolones given to hospitalized patients should never have been prescribed.
“It’s been very easy for clinicians to prescribe fluroquinolones because they treat so many of these infections so effectively,” Jenkins said. “(The) fluroquinolone class of drugs should really only be used when there are no equally effective alternative antibiotics available to treat infections.”
In response to growing reports of disabling reactions, in 2018 the FDA issued its strongest black box warning for these drugs. The warning is designed to draw attention to serious or even fatal side effects.
Jenkins says more than a warning, doctors need to be better educated.
“Getting the message out to providers and patients that there are real risks associated with these drugs, but there is still a lot of work to be done,” he said.
“Life can turn in no time, and it did”
Mike Mendoza says his wife Dawn was a happy, healthy 49-year-old woman until she started taking Cipro.
“I saw her at the bottom of the pool, and that’s how I found my wife that day,” he says. “Life can turn on a penny, and she did.”
Mendoza says a doctor prescribed the antibiotic to his wife after she was diagnosed with pneumonia. Seven days later, he says he found his wife at the bottom of their swimming pool in Florida.
“She had tied herself to a hunting lounge and rolled around in the pool,” he said. “I know that drug put her in a state where it was over. She lost hope.
Mendoza says that in the 27 years they were together, his wife never suffered from depression.
“And she takes this drug in seven days and kills herself,” he said.
Reports filed with the FDA associate 221 suicides with Cipro and Levaquin as of December 31, 2021.
A last resort
Denver attorney Seth Katz has filed several lawsuits involving this class of drug. He stressed that it is important for patients to ask lots of questions before taking these antibiotics.
“It’s a very potent drug, and it should be used with care,” Katz said. “Ask your doctor tough questions. Do some research. Do they get their information only from a drug manufacturer or do they do their own independent research? »
Katz insists that fluroquinolones should always be the last resort, not the first choice.
Bayer, the pharmaceutical company that makes Cipro, said in a statement: “Fluoroquinolones are an important class of drugs that treat a wide range of bacterial infections…All drugs have potential side effects, but these risks are communicated to physicians and patients via FDA Approved Labeling.
For victims like Horne, they want to do more to protect patients.
“It’s a growing problem and it’s unresolved,” he said.
Bayer also said it closely monitors these antibiotics on an ongoing basis and that the safety of fluroquinolones has been well documented in clinical trials. But for those who suffer from side effects, it can be devastating.
“That drug, it killed my wife,” Mendoza said. “She took her down a rabbit hole that she couldn’t get out of.”
Bayer’s full statement:
“The health and safety of patients who use Bayer products is our top priority.
Fluoroquinolone antibiotics are an important class of drugs that treat a wide range of bacterial infections, many of which are serious and can be life threatening. Cipro® (ciprofloxacin) is one such drug in this class and is widely available as a generic drug which is manufactured and widely distributed in the United States by several companies.
All drugs have potential side effects, and the risks are communicated to physicians and patients in FDA-approved product labeling. The Cipro label already contains FDA-approved language informing physicians and their patients of the potential side effects associated with the use of this therapy, including specific warnings about central nervous system risks and other psychiatric effects for help physicians and patients make informed decisions.
The safety and effectiveness of Bayer’s fluoroquinolones have been demonstrated in clinical trials involving over 90,000 patients and extensive clinical experience in over 800 million patients. Cipro was originally approved by the FDA in 1987.
Bayer closely and continuously monitors the safety and effectiveness of its fluoroquinolones, as we do with all of our products. As with any prescription medication, Bayer encourages patients to discuss the risks and benefits of these medications with their healthcare provider.
We recommend that you visit fda.gov for more information about the FDA’s position on adverse event reporting.