DENVER — Some of the most popular drugs prescribed to treat bacterial infections can cause serious side effects and are overprescribed, according to studies and reports.
The Food and Drug Administration has said that Cipro (ciprofloxacin), Ofloxacin and Levaquin (levofloxacin) — prescription drugs known as fluoroquinolones — can have rare but serious side effects. Those side effects include tendon rupture, neuropathy, impacts to the central nervous system and suicide.
“It destroyed my life,” said Jon Horne, who was prescribed Ofloxacin.
Horne lives in Aurora and says his doctor prescribed him Ofloxacin to treat a stomach infection while on vacation with his family.
“I took the pills and I just don’t know, I went full psychotic,” he said.
Horne has been diagnosed with neuropathy, which leaves him in chronic pain.
“I’m being burned alive and getting stung by bees and have constant Charlie horses,” he said.
Horne says he does not 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 an expert Center for Disease Control and Prevention panel investigating the overuse of antibiotics like fluoroquinolones. The study found 47% of fluroquinolones given to patients in the hospital should have never been prescribed.
“It’s been very easy for clinicians to prescribe fluroquinolones because it treats so many of these infections so effectively,” Jenkins said. “(The) fluroquinolone drug class should really only be used when there are no equally effective alternative antibiotics that are 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 call attention to serious, even life-threatening side effects.
Jenkins says more than a warning, doctors need to be better educated.
“Getting the message out to both providers and patients that there are real risks associated with these medications, but there is a lot of work left to be done,” he said.
“Life can turn on a dime, and it did”
Mike Mendoza says his wife Dawn was a happy, healthy 49-year-old 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 said. “Life can turn on a dime, and it did.”
Mendoza says a doctor prescribed his wife the antibiotic after she was diagnosed with pneumonia. Seven days later, he says he found his wife at the bottom of their pool in Florida.
“She had latched herself to a chase lounge and rolled herself into the pool,” he said. “I know this drug put her in a state of mine where it was over. She lost hope.”
Mendoza says in the 27 years they were together, his wife never suffered from depression.
“And she gets on this drug in seven days and takes her life,” he said.
Reports filed with the FDA tie 221 suicides to Cipro and Levaquin as of Dec. 31, 2021.
A last resort
Denver Attorney Seth Katz has filed multiple lawsuits involving this class of drug. He stressed it's important patients ask lots of questions before taking these antibiotics.
“It’s a very strong drug, and it should be used carefully,” Katz said. “Ask your doctor hard questions. Do some research. Are they getting their information solely from a drug manufacturer or are they doing their own independent research?”
Katz insists fluroquinolones should always be the last resort, not the first choice.
Bayer, the drug company that makes Cipro, said in a statement, “Fluroquinolones are an important class of medications that treat a wide range of bacterial infections... All medications have potential side effects, but those risks are communicated with doctors and patients through FDA-approved labeling.”
For victims like Horne, they want more done to protect patients.
“It’s a growing issue and it’s not getting addressed,” he said.
Bayer also stated it closely monitors these antibiotics on an ongoing basis and the safety of fluroquinolones has been well documented in clinical trials. But for those who suffer side effects, it can have devastating impacts.
“That drug, it killed my wife," Mendoza said. "It 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 medications that treat a wide range of bacterial infections, many of which are serious and can be life-threatening. Cipro® (ciprofloxacin) is one such medication in this class and is widely available as a generic medication that is manufactured and supplied widely throughout the United States by several companies.
All medicines 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 advising physicians and their patients about the potential side effects associated with the use of this therapy, including specific warnings about the risks of central nervous system and other psychiatric effects to help physicians and patients make informed decisions.
The safety and efficacy of Bayer’s fluoroquinolones have been demonstrated in clinical trials involving more than 90,000 patients and extensive clinical experience in more than 800 million patients. Cipro was originally approved by the FDA in 1987.
Bayer closely monitors the safety and efficacy of its fluoroquinolones on an ongoing basis, 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 visiting fda.gov for more information on the FDA’s position of adverse event reporting.”