Yesterday the FDA announced it will now require updated box warnings on fluoroquinolones like Cipro and Levaquin. The new labels will advise that serious side effects associated with the drugs outweigh the benefit for many patients. This label change comes after thousands of reports of adverse reactions linked to the medications. Click here to read more about the FDA's decision.
These are "big gun" antibiotics prescribed to knock out conditions like sinus, urinary tract and ear infections, but hundreds of thousands of patients say the drugs do that and more, claiming they've experienced nerve damage, heart problems, and ruptured tendons.
We talked to a local mom who says the antibiotic she took turned her life upside down. Kelly Love describes it as a bomb going off in her body. Three years ago this Union Grove mom of four was prescribed a powerful antibiotic, Cipro, for a bacterial infection.
"I literally couldn't use my body," she said.
Kelly says she reacted to the first pill. Then came joint pain. On the fifth day, Kelly says her symptoms got scary.
"I woke up in the middle of the night with an electric shock like feeling in my body. Pain that I can't even describe to you how bad it was."
Kelly ended up in the emergency room. Doctors were stumped. She couldn't walk, and with her symptoms getting worse, Kelly was referred to a doctor at the Mayo Clinic in Minnesota.
"He believed it was a reaction to the antibiotic. There was nothing to do for it. The nerve damage and all of that was already done."
Over the years, reports have flooded into the FDA. Patients complain of similar side effects like pain, muscle weakness, tendon rupture. All of them took an antibiotic in the fluoroquinolone or "FQ" family.
There are five on the market right now, including brand names Cipro and Levaquin. The FDA's database of complaints about those two drugs show almost 200,000 adverse reactions from 1997 to 2015, including more than 3,600 reported deaths. It's estimated only 10 percent of patients who experience side effects report them. Using that number, critics claim there have actually been many more deaths related to Cipro and Levaquin.
Michael Carome is the Director of Public Citizen in Washington, D.C. He calls adverse drug reaction a serious health problem. The consumer advocacy group has been studying FQ antibiotics for 20 years. It was behind the black box warning for tendon rupture the FDA added to fluoroquinolones in 2008.
Now the group is pushing for more warnings and testified before an FDA advisory panel in November. "The FDA will consider making labeling changes, and we hope they will do that sooner than later to protect public health and patient health," Carome said.
Designed to treat serious infections like pneumonia and anthrax exposure, FQ's are now among the most commonly prescribed antibiotics in the U.S. OB-GYN doctor Brian Bear says they're overused because they knock out infections quickly, but that can come with more side effects than other drug options.
"They really should be reserved for people who have recurrent infections or severe infections that won't respond to other antibiotics."
Kelly and her husband say life is completely different these days. She still lives with constant exhaustion and pain, and there are many things she can't do. "No bike rides, no hiking. I can't grocery shop alone. I can't handle pushing the cart."
Kelly still hopes she'll recover fully, but there's no research to tell her what to expect. "I might just have to get used to this being what life is going to be like."
In August of 2013, the FDA issued a warning about permanent nerve damage as a possible side effect of fluoroquinolones. That was months after Kelly took Cipro. Some FQ's have been removed from the market over the years because of their side effects.
As for the proposed labeling changes, the FDA is considering anything from advising drug manufacturers to more clearly stating the risks, to adding additional warnings. The FDA can also advise doctors not to prescribe these drugs for certain conditions.
We reached out to the FDA about it being six months since the advisory panel made its recommendations.
Statement from the FDA:
In November 2015, the FDA convened an advisory committee meeting to receive expert scientific advice regarding the benefits and risks of systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections. This included a discussion of the data regarding the benefit of these products to treat these conditions as well as the adverse effects of the drugs.
This meeting provided valuable information and perspectives to help inform the FDA's decision-making processes. The FDA plans to consider the input from committee members and the public from the advisory committee meeting and determine what future actions may be appropriate.
This is an important issue for the Agency. The FDA will keep health care providers and the public informed of new information regarding the use of systemic fluoroquinolones to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections.
Information for consumers and health professionals on new drug warnings and other safety information, drug label changes, and shortages of medically necessary drug products can be found on the FDA's drug safety and availability website here: http://www.fda.gov/Drugs/DrugSafety/default.htm
Healthcare professionals and patients are encouraged to report adverse events or side effects, product use errors, product quality problems, and therapeutic failures to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The manufacturers of Cipro and Levaquin say the drug labeling reflects all current safety concerns.
Statement from BAYER (Cipro/Avelox):
"Bayer appreciated the opportunity to present before the U.S. FDA's Advisory Committees in November 2015 about Cipro® (ciprofloxacin) and Avelox® (moxifloxacin), both part of the important fluoroquinolone class of antibiotics that has been used to treat a range of infections for many years. Bayer believes that these drugs are important medicines and that the benefits continue to outweigh the risks. We also maintain that the existing labeling for both these drugs reflects the current understanding of the safety and efficacy of fluoroquinolones.
"As the FDA noted during the meeting, advisory committees provide recommendations to the agency, but the FDA makes the final decisions. Bayer's highest priority is patient safety and we look forward to continue working with the FDA as it considers the Committees' recommendations."
Statement from Janssen Pharmaceuticals (Levaquin):
At Janssen, our first priority is the well-being of the people who use our medicines.
LEVAQUIN® (levofloxacin) is part of an important fluoroquinolone class of anti-infective prescription medications that has been used for nearly 20 years to treat infections, including those that may be serious or life threatening.
We appreciated the opportunity to present to the Advisory Committees about LEVAQUIN® last November. We believe the existing labeling appropriately reflects the current understanding of the safety and efficacy of the fluoroquinolone class, and we look forward to discussing the Committees' recommendations with the FDA as we continue our ongoing collaboration to support the safe and appropriate use of fluoroquinolone antibiotics.
Please see the full prescribing guide (http://www.janssen.com/us/sites/www_janssen_com_usa/files/products-documents/038271-150806_levaquin_uspi.pdf)
and medication guide http://www.janssen.com/us/sites/www_janssen_com_usa/files/products-documents/levaquin_med_guide_0.pdf
for further information
2013 FDA Warning of possible permanent nerve damage from fluoroqunolone antibacterial drugs.
FDA Advisory Committee Meeting notes/November 2015
WMAR-TV coverage of FDA Advisory Committee Meeting/November 2015
Public Citizen (Consumer Advisory Group)