Medical safety experts are petitioning for tighter regulations on a popular antibiotic already flagged for dangerous – and sometimes deadly – side effects.
The U.S. Food and Drug Administration already requires black box warnings to for a class of antibiotics known as fluoroquinolones, cited for disabling and potentially irreversible side effects, including suicidal thoughts.
But Dr. Charles Bennett, a nationally recognized medication safety expert, said no one is reading that warning, which is buried in a 35-page drug information insert.
“We have suicides after one or two days of antibiotics,” said Bennett. “The risks outweigh the benefits.”
Dr. Bennett has filed a petition with the FDA asking that doctors who prescribe this medicine get patients to sign a release that they understand the risks before taking the drugs.
An I-Team review of the FDA’s own data shows more than 20,000 reports of “nervous system disorders” – or psychiatric side effects, including anxiety and depression, connected to these antibiotics since 2000.
The FDA also reported 174 suicides tied to this medication in the past 20 years.
Since 2015, U.S. Food and Drug Administration has recognized a syndrome related to taking these antibiotics called Fluoroquinolone-Associated Disability or FQAD.
Still, U.S. doctors wrote 29.7 million prescriptions for these drugs in 2016 alone, according to the CDC.
The antibiotic has been sold under brand names Cipro and Levaquin. The drug maker Janssen is no longer making Levaquin, but the drug is still available in generic form.
Deana Poghen’s family blames her suicide on side effects from Cipro.
Witnesses say Poghen parked her car on the side of the interstate near her home on Christmas Eve in 2015 and walked in front of a semi-trailer truck.
Poghen’s mother, Florence Summers, described her as a happily married mother of two who loved life until she was prescribed Cipro just four months before her death.
“She was intelligent, vibrant and happy,” said Summers. “It was not her. She would have never, ever, ever done something like that.”
Laurie Walls said she also never experienced anxiety, muscle and joint pain and depression – until doctors prescribed her Cipro for a sinus infection in 2017. She told ABC Action News she no longer enjoys traveling long distances to see family or her favorite hobby – karaoke.
“I never in a million years thought an antibiotic would do this to a person,” said Walls.
ABC Action News contacted the FDA about Dr. Bennett’s petition. In a statement, the agency said:
“The FDA is reviewing the petition and will respond directly to the petitioner. It is important that health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use. For some serious bacterial infections, including bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for these antibacterial drugs to remain available as a therapeutic option. More information about fluoroquinolones can be found on FDA’s web site.”
The FDA could take more than a year to decide on Dr. Bennett’s request.
ABC Action News also reached out to Bayer, which makes Cipro.
In an email statement, the drug maker said:
“The health and safety of patients who use Bayer products is our top priority, and Bayer expresses its sympathies to the family of Ms. Poghen.
Cipro (ciprofloxacin) is a fluoroquinolone antibiotic, an important class of medications that treat a wide range of bacterial infections, many of which are serious and can be life-threatening. All medicines have potential side effects and the risks are communicated to physicians and patients in FDA-approved product labeling. The Cipro label 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.
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 and is now widely available as a generic medication that is manufactured and supplied widely throughout the United States by several companies.
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.
More information on fluoroquinolones from the FDA can be found here.