TAMPA, Fla. — Reports of deadly side effects are on the rise in one of the most widely prescribed antibiotics on the market.
I-Team investigator Jackie Callaway first exposed the dangers of Cipro and Levaquin in 2015. Now she reports on new hope in the fight to raise awareness.
No one, not Dawn Mendoza's husband nor the two daughters she loved fiercely imagined her 49th birthday would be her last.
Mike Mendoza told ABC Action News that in the 27 years they were together, his wife never suffered from depression.
"She was larger than life, she gets on this drug and in seven days, it takes her life," he said.
In 2019, a doctor prescribed the popular and powerful antibiotic Cipro after Dawn was diagnosed with pneumonia.
Mendoza said his wife stopped sleeping and became anxious after her first dose.
Dawn Mendoza chronicled her downward spiral over the seven days she was on Cipro. She wrote about sleeping two hours or less, anxiety attacks, and in one entry described feeling like she was "dying from the inside out."
Texts found on her phone indicate Dawn notified her doctor's office about the anxiety and insomnia. Mendoza said his wife was never warned of the drug's possible mental health side effects.
In the search for answers, Dawn, a vegan who exercised regularly, read the drug insert and found anxiety, insomnia and suicide warnings on page 12.
The woman who cherished her girls and loved life ended her suffering four days after she stopped taking the drug. Mike came home from work and found her dead at the bottom of their pool.
"She lashed herself to a chaise lounge and rolled herself into the pool," Mendoza said.
Reports filed with the FDA tie 219 suicides to Cipro and Levaquin, two popular antibiotics used to treat serious infections.
- The worst side effects of one of the most popular antibiotics is buried in fine print
- Popular antibiotics will come with strong warning after reported deaths
- FDA warns of antibiotics' mental health risks years after Purdue University student's death
- Medical expert petitions FDA for checks on popular antibiotic to protect public from suicide risk
Medical experts suspect thousands more because only 1-10% of all adverse drug side effects are ever reported.
A nationally recognized medication safety expert, Dr. Charles Bennett, petitioned the FDA in 2014 and again in 2019 for increased suicide warnings for Cipro and Levaquin. They're in a class of drugs known as fluoroquinolones.
In 2018 the FDA issued its strongest "black box" warnings for these drugs. It states that the antibiotics are "associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves and central nervous system."
The agency denied Dr. Bennett's petition to add suicide as part of the boxed warning, leaving it in a subsection on page 12 of the 52-page drug insert included with the prescription.
Dr. Bennett said physicians often don't know about the side effects associated with these drugs when they prescribe them. In an attempt to raise worldwide awareness, Dr. Bennett told the I-Team that he started work on a petition asking the CDC to recognize Fluoroquinolone Long Term Toxicity as a condition that can be billed to insurance.
"The biggest way to get providers to pay attention is when they can bill for incidents," Bennett said.
But the process could take years.
Meanwhile, the makers of Levaquin stopped making the drug, citing other options for treatment. This week Cipro's maker, Bayer, responded to ABC Action News in the following 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."
Victim's families say more needs to be done to warn patients and inform doctors of the potentially life-threatening risks.
If you experience adverse side effects from taking a drug, you can make a report to the FDA by clicking here.