Action 9

Some worry doctors don't know about new warnings on some antibiotics

CHARLOTTE, N.C. — A Charlotte woman helped push the U.S. Food and Drug Administration to change the warnings on certain popular antibiotics, but she and a South Carolina doctor are worried doctors aren't aware of the ruling.

These antibiotics are known as "fluoroquinolones." Popular brand names include Avelox, Cipro, and LEVAQUIN.

The FDA now believes they're linked with serious side effects involving tendons, muscles, joints, and the central nervous system. It says the side effects outweigh the benefits for people with less serious infections, like sinus infections and bronchitis. Last month, the FDA ruled that the companies that make these drugs need to include stricter warnings with the medications.

Doctor: “Most doctors don’t know”

But Dr. Charles Bennett, with the South Carolina College of Pharmacy, said, "I'd say most doctors don't know about this." He's been warning doctors and patients of the potential side effects since 2014.

He wants the companies that make these drugs to send every doctor in the country what's called a "Dear Doctor" letter, making them aware of the FDA's ruling. "It says, 'Dear Doctor, We want to inform you of important, new changes in the quinolones. Their risks outweigh their benefits for most diagnoses,’" he said.

Patient: “Long way to go”

The Charlotte woman, Rachel Brummert, said she only took LEVAQUIN for seven days, but since then, she's had tendons tear 10 times in 10 years. She blames the drug. "Everyday things that most people take for granted is difficult for people like me. Going to the supermarket-- most people don't think about it-- but for me, it will tire me out like you wouldn't believe," she said.

She spent months pushing the FDA to require more warnings on the drugs. Now, Brummert and her group, Quinolone Vigilance Foundation (http://www.saferpills.org/). is launching its own campaign to make doctors aware of the ruling. Brummert is speaking to doctor groups and meeting with the CDC in Atlanta. She said she met with officials there last month to discuss ways to track the side effects of these drugs better. "We've come a long way, but we've got a long way to go too," she said.

FDA and drug companies’ responses

The FDA and two major drug companies that make the brand-name versions of these drugs aren't saying what steps they'll take to make sure doctors are aware of the new warnings.

"This is the beginning of the safety-label change process and some of the exact language may change before the labels are finalized. The Sponsors will have an opportunity to respond to the labeling changes notification and engage in discussions with the agency. (The) FDA intends to complete the safety-labeling changes process as soon as possible," an FDA spokesperson told Action 9's Jason Stoogenke.

"Bayer's highest priority is the safety of patients who use our medicines. Millions of patients in the U.S. and around the world have relied upon Cipro® (ciprofloxacin) and Avelox® (moxifloxacin) to treat a range of infections, many of which are serious and can be life-threatening. Bayer will continue working cooperatively with the FDA on this topic. It is important that patients continue to have access to therapeutic options for treating bacterial infections that, if left untreated, can cause serious complications. Bayer is committed to helping physicians and their patients understand the benefits and risks associated with these medicines," a Bayer spokesperson told Stoogenke.

"At Janssen, our first priority is the well-being of the people who use our medicines. LEVAQUIN® (levofloxacin) is part of the important fluoroquinolone class of anti-infective prescription medications. We are reviewing the Drug Safety Communication and will continue to ensure our commitment to support the safe and appropriate use of fluoroquinolone antibiotics. LEVAQUIN® has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening," a Janssen spokesperson told Stoogenke.

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