INDIANAPOLIS -- The U.S. Food and Drug Administration has announced labeling changes to antibacterial drugs called fluoroquinolones following multiple Call 6 Investigations into safety issues.
The labeling changes will include an updated boxed warning and medication guide that advises serious side effects with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options.
Patients with those conditions should only use fluoroquinolones as a last resort, according to the FDA.
The announcement comes after years of public testimony and outcry about the drug’s disabling and deadly effects.
“The FDA takes seriously its responsibility to protect the health of the American public through the review of safety, effectiveness and quality of medical products for patients,” according to an FDA statement to Call 6 Investigates. “The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information.”
Indiana mother Heather McCarthy testified before an FDA panel after losing her son Shea, a Purdue University student, in what she believes is a drug-induced death.
"While more work needs to be done the FDA’s changes give weight to the testimony of all those suffering from fluoroquinolone toxicity and sends a clear message to doctors that these drugs must be used sparingly, only when necessary and that physicians must take seriously patient complaints,” said McCarthy in response to the FDA announcement.
McCarthy said the decision also validated her son’s belief that fluoroquinolones had a profound impact on his health.
Shea was prescribed the powerful antibiotic, Levaquin, prior to a nasal surgery.
Levaquin is the brand name for levofloxacin, which is part of a class of drugs called fluoroquinolones, intended to treat major infections like pneumonia, anthrax exposure, plague and urinary tract infections.
“He didn’t even have an infection,” said McCarthy. “This was just to prevent an infection from happening. It’s like taking a cannon to kill a mosquito.”
Heather said her son started acting strangely after taking Levaquin, and told doctors, friends and family he thought the drug was to blame.
Shea quit taking the medication, but the side effects still lingered, according to his mother.
Shea’s anxiety got so bad, he dropped out of school and ended up in the mental health system, where doctors prescribed him more drugs for bipolar disorder.
On Oct. 23, 2013, Shea jumped out of a second story window, got in his car, and crashed into a cement embankment. He died at the age of 24.
“It is now clear that this class of drugs affects multiple bodily systems including the central nervous system and includes neuropsychiatric adverse effects,” said McCarthy on Thursday following the FDA announcement. “I still believe the warnings in this area need to be stronger and under a separate heading so that no one will need to experience the long suffering O’Shea had to bear due to the refusal of his doctors to listen to him. “
McCarthy said she will work to heighten awareness surrounding neuropsychiatric effects of Levaquin and other powerful antibiotics.
A 2014 citizen petition to the U.S. Food and Drug Administration raised concerns about the psychiatric effects of Levaquin including depression, anxiety, and confusion that can start “days, weeks, or months after the last dose.”
The citizen petition requested the FDA add a black box warning on the Levaquin label for “serious psychiatric events,” but the FDA has not yet required that language on the label.
Janssen Pharmaceuticals, maker of Levaquin, released the following statement in response to the FDA label change:
At Janssen, our first priority is the well-being of the people who use our medicines. We are reviewing the Drug Safety Communication and will continue our ongoing collaboration with the FDA to support the safe and appropriate use of fluoroquinolone antibiotics. LEVAQUIN® (levofloxacin) has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening. LEVAQUIN® is part of the important fluoroquinolone class of anti-infective prescription medications, and its safety profile remains well-known and established.
Call 6 Investigates obtained the FDA database of adverse reactions to Levaquin and found more than 31,000 complaints since 2010, including 179 reported deaths.
Hundreds of patients complained of depression and anxiety, according to the database.
Critics of the drug, however, estimate 15,000 deaths related to Levaquin since 1997.