FDA Committee recommends label changes, warnings for popular antibiotics like Cipro, Levaquin

FDA Committee recommends label changes, warnings for popular antibiotics like Cipro, Levaquin
Dave Biscobing
6:47 PM, Nov 5, 2015
investigations

A Food and Drug Administration advisory committee overwhelmingly voted Thursday that one of the most common classes of antibiotics should change its labels to better inform and warn the public.

The Joint Meeting of the Antimicrobial Drugs Advisory Committee heard testimony from drug-makers, doctors and patients regarding the risks and benefits of using fluoroquinolones on some patients with bronchitis, sinusitis and urinary tract infections.

The committee voted that it believed changes to the label should be made regarding the treatment of those three conditions.

At the meeting, representatives for one of the drug-makers, Janssen Pharmaceuticals, said based on their present understanding, no new label changes needed to be made.

More information on the meeting can be found on the FDA’s website .

The committee’s vote serves as a recommendation. The FDA will now evaluate if any changes to the label need to be made and what those changes would be.

Fluoroquinolones are one of the most potent antibiotics approved by the Food and Drug Administration.

Some brand names included in the class are Cipro and Levaquin. The antibiotics are prescribed millions of times a year and most Americans will take one in their lifetime, experts said.

In a briefing about the meeting , FDA reviewers raised concerns about a “constellation of symptoms” that are being called Fluoroquinolone- Associated Disability, or FQAD.

People who may have FQAD were described in the report as:

Patients who were previously healthy
Patients who took a fluoroquinolone to treat a urinary tract infections, bronchitis, or sinusitis
Patients who experiences adverse events in two or more body systems, including peripheral neuropathy, neuropsychiatric, musculoskeletal, senses, cardiovascular, and skin.
Patients who had a substantial disruption of their normal life functions.
On page 28 of the briefing, reviewers concluded: “We find an association between oral fluoroquinolone use in previously healthy U.S. patients being treated for uncomplicated cases of sinusitis, bronchitis, or UTI, and the development of FQAD. While the individual components are included in fluoroquinolone labels, a description of the constellation of disabling adverse events is not currently described in the fluoroquinolone labels.”

The meeting comes nearly one year after an ABC15 Investigation exposed concerns by researchers and patients who believe that Levaquin carries more serious side effects than are listed on the label.

Last year, they filed a pair of citizen petitions asking the FDA to add new warnings to the label for a long list of psychiatric side effects ranging from depression to hallucinations, and also something called “mitochondrial toxicity.”

In simple terms, researchers say that means it could alter and damage the body’s cells.

Find the petitions here and here .

Medical experts told ABC15 that fluoroquinolones are important antibiotics because they successfully treat life-threatening infections.

However, their potency has also raises concerns about them being over-prescribed and used to treat minor conditions or infections.

In 2013, the FDA added a warning to fluoroquinolone labels for nerve damage. In 2008, the FDA forced a black box warning because it can cause tendons to snap.

A black box warning is the highest action the FDA can take before pulling a medication off the market.

Contact ABC15 Investigator Dave Biscobing at dbiscobing@abc15.com

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