A New Outlaw in the Levaquin Side Effects Corral

. By Gordon Gibb

Levaquin has long been a source of frustration for patients with regard to Levaquin side effects ranging from pain to tendon ruptures. But there is a new scourge emerging from the use of the fluoroquinolone that has actually been on the FDA radar since 2004, with an updated label finally coming last fall. Critics and plaintiffs say manufacturers and the US Food and Drug Administration aren’t doing enough.

The issue is peripheral neuropathy, which in lay terms can be summed up as nerve damage.

Sometimes it can be permanent.

Jenny Frank knows all about it. The 54-year-old resident of Glendale, Arizona, was prescribed a round of Levaquin to combat an infection, the nature of which was not identified in the news report. According to The Arizona Republic (9/17/14), Frank was doing fine until seven days into her relationship with the fluoroquinolone, when she experienced dizziness so severe Frank had to go to the emergency room of her local hospital to find out what was wrong.

Subsequent to her dizziness from Levaquin side effects, she began experiencing pain in her knee and swelling in her ankles a few weeks later. And that wasn’t the end of it. Frank began to feel anxious and became prone to panic attacks. There were muscle spasms, gastrointestinal issues and fatigue. She was forced to employ braces to her knees, elbows and wrist. She had to start using a cane, and took a leave of absence from her job.

“Every single day, something else in my body fell apart,” said Frank, in comments to The Arizona Republic. The report further states that Frank is “mostly” recovered from “the worst of her pains” that started three years ago when she was prescribed Levaquin.

So what was it that Frank was dealing with? Levaquin Peripheral Sensorimotor Neuropathy, Levaquin side effects that have been a concern since 2004. However, it wasn’t until August 2013 that the FDA got around to issuing a communiqué following analysis of a “continued association” between all fluoroquinolones - including Levaquin and Levaquin Peripheral Sensorimotor Neuropathy, concluding that the “potential rapid onset and risk of permanence” when it came to potential nerve damage “were not adequately described” in the original warning issued in 2004.

Thus, Levaquin side effects warnings were updated for the Levaquin label last fall, together with warning labels for other drugs in the fluoroquinolone class.

That’s not good enough for the signatory of a citizen’s petition submitted over the summer by a researcher on behalf of a Phoenix resident and other patients who took Levaquin and other fluoroquinolones and suffered Levaquin side effects. The petitioners want a further update to the warning labels with regard to the potential for permanent damage to the mitochondria in human cells.

That was in the summer. Last month, the same group issued a petition to the FDA for additional warnings with regard to the potential for psychiatric side effects stemming from nerve damage.

It should be noted that the potential for Levaquin Peripheral Sensorimotor Neuropathy is limited to oral and injectable fluoroquinolones, as compared with topical versions of the medication, which are considered not to pose the same kinds of risks.

Was the overuse of Levaquin and fluoroquinolones foreseen?

That said, according to various sources, there were 23 million patients prescribed an oral fluoroquinolone - including Levaquin - for infection in 2011, along with 4 million others who received the medication through an injection. That’s 27 million Americans with the potential for Levaquin Peripheral Sensorimotor Neuropathy. Adding to the concern is the fact that fluoroquinolones such as Levaquin - originally designed and approved to treat extremely serious infections - have been increasingly prescribed for the treatment of relatively minor infections for which fluoroquinolones were never originally indicated. Doctors have always possessed the medical, ethical, legal and regulatory freedom to prescribe medications off-label, but this doesn’t help patients who have implicit trust in their doctors and are potentially being exposed to serious Levaquin side effects such as Levaquin Peripheral Sensorimotor Neuropathy, without need.

It behooves the manufacturers and the FDA, say pundits, to better educate consumers and the medical community with regard to the potential for serious and lasting nerve damage when trying to combat a relatively minor infection. This can be done though further label changes and consumer education.

The FDA, it is noted, has advised doctors to avoid prescribing fluoroquinolones for relatively minor infections and instead advocate its use only for the most serious infections in order to support the benefits/safety profile under which Levaquin and its ilk were approved in the first place. The federal regulator, meanwhile, seems comfortable with its label change recommendation in August 2013, and is continuing to monitor the file before it imposes any further changes to the label for Levaquin side effects. “Think of drug labels as living documents,” FDA spokesperson Stephanie Yao said in comments published in The Arizona Republic.

That’s cold comfort for people like Jenny Frank and others who have suffered the rigors of Levaquin Peripheral Sensorimotor Neuropathy. Little wonder a Levaquin Antibiotics lawsuit is pursued when serious and lasting nerve damage results from just popping a little pill for just a few days…

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