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FDA backlog delays Indiana mom's efforts on antibiotic warnings

Heather McCarthy frustrated at federal agency’s response to petition
Posted: 10:33 AM, Jan 22, 2020
Updated: 2020-01-22 20:55:21-05
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INDIANAPOLIS — A backlog at the U.S. Food and Drug Administration is delaying an Indiana mother’s efforts to require more stringent warnings on commonly prescribed antibiotics called fluoroquinolones.

Heather McCarthy has been pushing for changes after the 2013 death of her son, Shea McCarthy, a Purdue University student.

Shea was suffering mental health side effects from taking the antibiotic Levaquin, according to his mother, and died after he crashed his car into a cement embankment.

Fluoroquinolones are typically prescribed to treat severe 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.

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.

On Dec. 17, six months after the petition was filed, the FDA responded to Dr. Bennett saying the agency hasn’t resolved the issues raised in the petition.

“FDA has been unable to reach a decision on your petition due to the need to address other agency priorities,” read the FDA’s response.

Call 6 Investigates sent an email to the FDA on January 15, seeking more information about their letter, and we are still waiting to hear back.

The FDA’s lack of investigation thus far is infuriating to people who have been fighting for label changes to fluoroquinolones.

“This is the current government’s way of dealing with regulatory issues – they are understaffed and pretty much not equipped to do the work they are charged with carrying out – public safety,” said McCarthy. “This response from the FDA sends the message loud and clear that our regulatory agency has failed in its core mission of ensuring patient safety leaving little hope that the damage that has been done to so many citizens by this drug will continue despite our ongoing efforts to implement warnings for patients and prevent further victims. The FDA, under the guise of priorities, has essentially chosen to ignore those who have witnessed first-hand the detrimental effects of this class of drugs.”

Although McCarthy was not involved directly in the petition, she may testify before the FDA about what happened to Shea.

“This is unacceptable, and I assure you those who have lost loved ones and have been damaged by Levaquin will continue to make this their priority, despite the FDA’s lack of interest in addressing these harms, until the proper warnings are in place,” said McCarthy.

The citizen 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.

“This is really concerning because the response we received is that they haven’t read the materials,” said Dr. Bennett. “That response was something we’ve never gotten in my 34 years of working with the FDA.”

Bennett said the longer the FDA waits, the more people could be harmed by the antibiotics.

“What’s at stake is lives,” said Bennett. “Every day that passes without patients being informed of life-threatening side effects is real lives that are lost.”

Bennett, McCarthy and others are urging the FDA to take action.

“It’s important because without a well-written product label, patients are uninformed,” said Bennett. “We have a side effect that includes suicide, that includes psychiatric disabilities for a drug that’s been used 22 million in the United States, which is 10 percent of the population.”

McCarthy believes Shea was suffering from FQAD, but it was not diagnosed at the time.

FQAD is a cluster of disabling symptoms that result in a substantial disruption to a person’s ability to live a healthy life.

“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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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 .

The drug maker, Janssen, stopped making Levaquin in December 2017.

PREVIOUS | Drug maker stops making popular antibiotic

However, Bennett said the drugmaker is still responsible for the drug’s label and medication guide.

Plus, an estimated 22 million people in the United States use the generics of Levaquin and Cipro.

“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.”

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.”

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.

Kristen Plunchino, a spokesperson for the FDA, said the agency is continuing to work to resolve the issues raised by McCarthy. Pluchino said the FDA will respond to McCarthy and post the response on its website.

Janssen, the maker of Levaquin, provided the following statement to RTV6:

“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.”

McCarthy testified in November 2015 before an FDA advisory panel convened to talk about fluoroquinolones.

MORE | FDA meeting on side-effects of antibiotics

“This was a drug-induced death that was unnecessary,” McCarthy told the panel.