INDIANAPOLIS— The U.S. Food and Drug Administration is requiring drug label changes for commonly prescribed antibiotics, including more prominent and consistent warnings for mental health side effects.
For several years, Call 6 Investigates has been looking into potential safety issues and concerning side effects associated with fluoroquinolone antibiotics sold under brand names like Levaquin, Cipro and Avelox.
Purdue University student Shea McCarty died in 2013 after jumping out of a second story window and crashing his car into a cement embankment.
His mother, Heather McCarthy, said Shea was agitated and suffering mental health side effects from taking the antibiotic Levaquin.
McCarty, as well as Dr. Charles Bennett with the Southern Network on Adverse Reactions (SONAR), have been pushing the FDA to better warn the public about the psychiatric effects of the drugs.
On September 11, 2014, Bennett filed a petition with the FDA calling on the federal agency to change the drug labels to better warn patients of the risks.
On July 10, 2018, the FDA responded with a safety announcement in which it called for label changes on fluoroquinolones including more prominent and consistent warnings for mental health side effects.
The mental health side effects, according to the FDA, include disturbances in attention, disorientation, agitation, nervousness, memory impairment, serious disturbances in mental abilities, and delirium .
Heather McCarthy told Call 6 Investigates Monday the FDA’s announcement is a breakthrough in acknowledging the drugs’ effects.
“While justice is slow - this label will now open the doors to accountability for doctors who chose to ignore patient complaints,” McCarthy said in an email to RTV6 Monday. “I personally believe there is a never a reason for doctors not to listen to patients and with this labeling, there is no longer a viable excuse to ignore patient complaints associated with fluoroquinolones. The key here is ending the degradation that patients must go through when they believe they have had an adverse effect from these drugs.”
Dr. Bennett called the FDA’s July 10 announcement a “huge paradigm shift.”
“The FDA has decided to markedly change the package insert,” said Bennett. “It’s been 15 years and coming. They clearly identify psychiatric side effects as an important quinolone associated toxicity.”
Bennett said making mental health side effects more prominent on warning labels is a good start, but not a fix.
“It’s very hard to get the doctors attention with just a warning change, so, no I’m not convinced this will result in the necessary outcomes that we want to see which is lives saved,” said Bennett.
Bennett says what needs to happen is the patient, doctor and pharmacy all need to sign off that they’ve been educated about the drug beforehand.
Bennett is also pushing for a gene test you can take before you use a fluoroquinolone so you can see if you’re more susceptible to side effects.
He said the FDA should also consider warning labels that address the risk of suicide.
“We looked into suicides which we think is a clear association with the quinolones, and the change in the package insert do not address suicide as an important toxicity,” said Bennett. “We’ve identified 122 patients with suicide with Cipro or Levaquin and 45% within 2 weeks of starting the drug.”
In 2016, the FDA announced an updated boxed warning and medication guide that advised 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.
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.
Call 6 Investigates contacted Janssen, the maker of Levaquin, about the FDA’s July 10 announcement.
“At Janssen, our first priority is the well-being of the people who use our medicines. Janssen is reviewing the Safety Labeling Change Notification and working with the FDA to ensure labeling will be updated appropriately to facilitate the safe and appropriate use of LEVAQUIN®,” said Kelsey Buckholtz, Janssen spokesperson in a statement to RTV6. “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 also contacted Bayer, who makes Cipro and Avelox, about the FDA’s label change.
Bayer released the following statement:
“Fluoroquinolones, including Cipro® (ciprofloxacin) and Avelox® (moxifloxacin), are an important class of antibiotics that treat a range of bacterial infections, some of which are serious and can be life-threatening. Cipro has been used in more than 600 million patients worldwide since becoming available by prescription in 1987. Avelox has been used by more than 200 million patients since it became available in 1999.
FDA, on July 10, 2018, issued an announcement [fda.gov] to reinforce safety information about the risks of low blood sugar levels and mental health side effects with fluoroquinolone antibiotics, and is requiring label changes for these products. This is a class-wide labeling change for all NDA and ANDA holders of fluoroquinolone antibiotics. Companies have 30 days to respond to the proposed label changes. Bayer is currently reviewing the proposed Labeling Change Notifications for Cipro and Avelox, and we will respond to the agency within the required time frame.
The current approved product labeling of both Cipro and Avelox reflects the benefit-risk profile of these drugs in their approved indications, including information about the risks of mental health side effects and hypoglycemia (low blood sugar).
Bayer’s highest priority is patient safety and we closely monitor the safety and efficacy of Cipro and Avelox on an ongoing basis. Bayer takes all reports of side effects very seriously, investigates them thoroughly, reports them to health authorities around the world as required and regularly evaluates whether the product’s benefit risk profile is adequately reflected in the product information.”
Heather McCarthy testified in November 2015 before an FDA advisory panel convened to talk about fluoroquinolones.
“This was a drug-induced death that was unnecessary,” McCarthy told the panel.
McCarthy filed a lawsuit in Lake County against the doctors who treated Shea, alleging they ignored her son’s assertion that Levaquin caused his mental health problems, and that the doctors were inflexible in their treatment of her son.
The lawsuit is still ongoing, McCarthy said Monday.
“The hardest thing about this is my son knew what was wrong with him, and no one listened to him,” McCarthy said. “It breaks my heart. We put faith in a system that failed us horribly.”
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