They’re certain antibiotics, known as fluoroquinolones. Popular brand names include Avelox, Cipro, and Levaquin.
Now, the U.S. Food and Drug Administration says these antibiotics “can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body,” the aorta. The FDA says these ruptures “can lead to dangerous bleeding or even death.”
The FDA is requiring drug makers to add a new warning to the packaging, saying “fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available.”
The FDA says those patients are ones with “a history of blockages or aneurysms” of blood vessels, high blood pressure, certain genetic disorders and the elderly.
For years, Sherry Reiver has been claiming that’s what happened to her father, Louis Hellman. She says in 2011 doctors thought her father had pneumonia and gave him a fluoroquinolone antibiotic. She says he died from a ruptured aortic aneurysm. He was 93 years old. “I miss his sense of humor. He had a really dry sense of humor. And he always told me, ‘Don’t worry, be happy.'”
Action 9 asked Reiver what she thought of the FDA’s latest warning about fluoroquinolones. “Vindicated, validated that I had been right,” she said. “I’ve told so many doctors that [those medicines] cause [aortic ruptures] and they look at me as if I have 10 heads.”
Rachel Brummert helped push the FDA over the years to issue other warnings about these medicines. She lives here in Charlotte. “I was not surprised by this latest warning. This was something that advocates had been pushing for for a long time,” she said.
Dr. Charles Bennett also saw it coming. He runs the only state-sponsored pharmaceutical watchdog program in the country, which happens to be in South Carolina. “What we do is look for fatal or near-fatal side effects of billion-dollar drugs,” he told Action 9.
He called this latest warning “a huge deal. It’s a game-changer, I think.”
But Brummert and Bennett both worry that patients, and even doctors, don’t know the risks.
These antibiotics can be lifesaving against infections. And the pros can outweigh the cons. Roughly a dozen companies make these drugs, including the generics and the brand names. One of them, Janssen Pharmaceuticals, told Action 9 “our first priority is the well-being of the people who use our medicines,” that its antibiotic “has been used for more than 20 years,” and that its “safety profile remains well-known and established.”
This is the latest warning about fluoroquinolones.
In 2015, some patients and doctors blamed the antibiotics for devastating side effects, including ALS, Alzheimer’s, Parkinson’s and even death.
In 2016, the FDA required drug makers to include warnings the drugs could have disabling effects on tendons, muscles, joints and nerves.
Later that year, the FDA added more warnings about the risks of mental health side effects and serious blood sugar disturbances.