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A New Outlaw in the Levaquin Side Effects Corral

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Glendale, AZLevaquin 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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READER COMMENTS

Posted by

on
11/2013 Dr. ordered levaquin for a cough. Next day I called him about my achilles heal hurting. Told me to stop the pills. I only had taking 2 pills. 11/2014 Had another little cough. The Dr. obviously didn't enter the last levaquin episode so he ordered it with prednidsone, not a good combination at my age. I had a lot going on that year, so I forgot about the year before. I had taken 2 pills again. That night my husband call 911 because I was in severe paid and no one could touch me. The first responders had to put me on the gurny with my sheet, because I was in such pain. Well all through 2015 I had many tendons that had to have cortizone shots, i.e., ankle, wrists. Pain in almost every joint, i.e., shoulder, neck, back, feet that had and have hairline fractures, fingers. Now my groin is painful when walking, sitting, I sit on a ring. Every day I wake up with another pain some where else. I hope there is an end to this. God Bless

Posted by

on
MARCH 20 2015
I WAS GIVEN LEVEQUIN FOR SINUSITIS AFTER TWO DAYS MY ACHILLES TENDON AND LEG ARE SWOLLEN AND SO PAINFUL I CAN NOT STAND TO WALK OR STAND
I WENT TO MY DOCTOR IN WEDS 3-25-2015 BECAUSE OF MY FOOT AND SEVERE STOMACH PAINS. HE WAS LEAVING FOR SPRING BREAK IN TOLD ME IT WAS FROM LEVEQUIN AND TO KEEP TAKING THE FULL DOSE OF TEN MORE PILLS. I AM NOT SURE WHAT TO DO
I HAD ACHILLES TENDON SURGERY LAST YEAR AND IT HAS HEALED BUT THIS FEELS LIKE IT FELT BACK THEN
BEFORE SURGERY. HELP I HURT
DEB

Posted by

on
[This is my] Report of bad drug reaction:
Drug: LEVOFLOXACIN 500 MG tablets
Mfgr: AUROMEDICS
Purpose: cure a difficult sinus infection

ADVERSE REACTION details:
After eating a late lunch 4PM to 4:30 PM, I took the FLUCONAZOLE tablet. At 5:PM I took one LEVOFLOXACIN tablet with 8 OZ water. By 9:30 PM the skin and veins [but not the tendons] on the back of both legs from the calf to the ankle had turned a nasty beet red and I began to experience increasingly agonizing pain in these distended veins. I immediately stopped work & began preparing for bed where I elevated my legs on a soft pillow. By the time I got into bed other veins in both thighs and groin had begun to hurt. At that time, I carefully read the 3 page warnings and side effects sheets accompanying the prescription. There was NO mention of vascular damage whatsoever!! The pain lessened after about an hour on the bed. During the night at 3 AM when I got up to go to the bathroom, the agonizing pain returned the minute I put my feet on the floor.

On Sunday in order to work on a drawing for a client, I had to put on a pair of old supp-hose to cradle the affected veins. I was forced to sit on my bed with my legs elevated on a pillow to begin the drawing. The pain returned all day when I got up to fix meals or go to the bathroom. During Sunday I drank 8 oz of water every hour to flush the drug residue out of my system. Sunday night I again elevated my legs on a soft pillow. During the night the pain was markedly less, but STILL THERE. Monday morning the vein distention is still there, but less painful, but now the tendons in my feet and ankles ARE definitely affected as well.

I have reported this to the FDA MEDWATCH and to the mfgr. AUROMEDICS.
21 Mar. 2015 - update - Less pain, but veins in left leg drastically affected and a painful lump of veins, capillaries & tissue has developed on my left shin. Unable to move toes and left ankle without pain. CM Ward

Posted by

on
I have been prescribed Cipro over the years for on/off UTIs. In June 2008, I was prescribed Levaquin after having a severely infected Internal Nerve Stimulator surgically removed by my Neuro Doctor. I had taken 3-4 doses and started feeling strangely. My nerves seemed on fire, burning bone pain, numbness, tingling, and complete loss of coordination. My doctor immediately discontinued the Levaquin, but put me on Cipro, instead. I have been in a pain management program for years due to this "unexplainable pain", which is getting worse and debilitating. I cannot function......and was always an active, vivacious, outgoing, working woman, till this all started. I was a Neuro Trauma Registered Nurse till this took over my life. Seems no one cares. I moved, six months ago, from NC to Laughlin, NV, thinking the climate might help my condition. And transferred my pain management to a "doctor" out here. I see him every month, and have told him about my increasing numbness in my hands & feet. He told me "that isn't possible", and doesn't seem to care. I don't know what to do......And I went through all of this, while taking care of my late husband, till his death....And it continues to this day. I've had too much pride to apply for disability, and don't think my own country will help me, anyway.....considering, they only help illegal immigrants.It saddens me......I put myself through college, led an active life helping others....and can get NO help from my own country, or profession, whom I have given so much. God help us all.

Posted by

on
My doctor prescribed Levaquin for a sinus infection. After taking the fifth pill (out of ten prescribed) i started limping because of severe pain in my achilles tendons on both feet. I called my physician and was told to stop the medication. That was over two weeks ago and I still can barely walk because of the pain. I am scheduled for an MRI, but have not been given any advice on what, if anything, I can do to alleviate the pain.

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