INDIANAPOLIS — A new effort is underway to change the labels on commonly prescribed antibiotics called fluoroquinolones following the death of a Purdue University student.
The drugs are typically prescribed to treat serious infections like pneumonia, and the U.S. Food and Drug Administration now says the drugs should not be used to treat common infections like bronchitis, UTIs or sinusitis.
Shea McCarthy, a Purdue student, took the antibiotic Levaquin to prevent an infection following surgery to fix a deviated septum.
Shea died in 2013 after he jumped out of a second story window and crashed his car into a cement embankment.
Shea was suffering mental health side effects from taking the antibiotic Levaquin, according to his mother, Heather McCarthy.
“He was suffering from anxiety and depression, and I believe it just overcame him,” said McCarthy. “This was a young man who wanted to live. This didn’t need to happen, and he didn’t need to go through this.”
On June 17, the Southern Network for Adverse Reactions (SONAR) and Dr. Charles Bennett submitted a citizen petition to the FDA requesting a black box warning to specifically identify psychiatric adverse events, including suicide and suicide-related adverse events.
Although McCarthy was not involved directly in the petition, she may testify before the FDA about what happened to Shea.
“The goal of this petition is to make sure a patient is well informed of the potentially dangerous and they’re informed of alternative treatments that don’t involve fluoroquinolones,” said McCarthy. “Shea can’t speak out now. He’s gone, but I can.”
McCarthy said Shea tried to tell his doctors he believed Levaquin was to blame, but they didn’t believe him.
“So often, the medical professionals give that no credence,” said McCarthy. “He felt like it was messing it with his mind, and it was his impression it was coming from this drug.”
The June 2017 petition also requests the FDA add Fluoroquinolone-Associated Disability (FQAD) to the black box warning, and implement a risk evaluation and mitigation strategy for Levaquin.
FQAD is a cluster of disabling symptoms that result in a substantial disruption to a person’s ability to live a healthy life.
McCarthy believes Shea was suffering from FQAD, but it was not diagnosed at the time.
“It’s beyond words the devastation this has caused to our family,” said McCarthy.
Since 2015, 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.
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Dr. Charles Bennett with the Southern Network on Adverse Reactions (SONAR), has 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 .
Bennett also filed the new petition on June 17 that calls for a FQAD and psychiatric adverse events black box warning, as well as the implementation of a risk evaluation and mitigation strategy for Levaquin.
“This is serious,” said Bennett. “We want FQAD in the black box warning. Everyone show know about it, and you certainly want to know about suicide in a black box warning.”
The drug maker, Janssen, stopped making Levaquin in December 2017.
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However, Bennett said the drugmaker is still responsible for the drug’s label and medication guide.
“Under the regulations, which the Supreme Court has reinforced, the manufacturer label for Levaquin or any drug must be maintained by the brand name manufacturer, even if they don’t market the drug,” said Dr. Bennett. “The generic manufacturer may not change the label in any way, shape or form.”
Bennett said 22 million people in the United States use the generics of Levaquin and Cipro.
“The generic of Levaquin and Cipro is still used by 10 percent of the United States population,” said Dr. Bennett.
Based on adverse event reports to the FDA, Bennett said the antibiotics have harmed many.
“We’re talking about a couple hundred thousand people with this toxicity that puts this in the range of opioids in terms of national toxicity,” said Dr. Bennett.
Dr. Bennett hopes the new citizen petition will lead to label changes not just with Levaquin, but all fluoroquinolones.
“We fully expect that if this petition is responded to positively, that this will be across the board,” said Dr. Bennett. “The FDA has made it clear they want to see the package inserts among fluoroquinolones harmonized.”
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 hopes the FDA will hear and approve their latest petition to address FQAD and 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,” Bennett told RTV6 in 2018. “We’ve identified 122 patients with suicide with Cipro or Levaquin and 45% within two weeks of starting the drug.”
In 2016, the FDA announced an updated boxed warning and medication guide that advised severe 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 significant infections like pneumonia and anthrax exposure.
Janssen, the maker of Levaquin, provided the following statement in 2018.
“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 in 2018.
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.
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“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.
