“I was given the antibiotic Levaquin. After 5 pills my body was burning and my right arm and legs were weak,” a reader posted after an article about underreported prescription drug dangers. “I discontinued the drug and was told I would be fine. 1 month later my feet started hurting, my knees developed chronic pain and I had stabbing pain in my quads. 13 months later, I have floaters in my vision, tinnitus, flat and deformed feet, rotator cuff damage, knee grinding, hip snapping, tendonitis and I can only walk for a few minutes.”
After taking Levaquin, another patient had “multiple areas of tendinitis in triceps, biceps, rotator cuff, hip flexor, feet and lower back,” he wrote on the web site askapatient.com. “I had joint swelling and severe pain in my wrists and fingers, generalized fluid retention and edema, joint popping with any movement in feet, ankles, knees and hips.” Before taking Levaquin, “I was a sponsored athlete—happy, strong and active. Levaquin has ruined me.
The drug the patients are talking about, the antibiotic Levaquin (levofloxacin), is part of a group of drugs called fluoroquinolones, widely used until recently for urinary tract infections, bronchitis, sinusitis and other infections. Other drugs in the class include Avelox (moxifloxacin), Cipro (ciprofloxacin), Floxin (ofloxacin), Factive (gemifloxacin mesylate) and Noroxin (norfloxacin). Patients’ stories about taking Levaquin share striking similarities. Illinois resident Jerzy Tyszkowski who filed a complaint against Johnson & Johnson and Ortho-McNeil-Janssen Pharmaceuticals, Inc. about Levaquin in 2013, says he developed severe orthopedic, gastrointestinal, neurological, visual and renal injuries after taking the drug for only five days.
Like many prescription drugs AlterNet has told you about, the enormity of Levaquin’s risks did not emerge until it went off patent and all possible profit was netted. (Until then, the drug was making manufacturer Johnson & Johnson over $1 billion a year and was the top-selling antibiotic.) Worse, the FDA did not acknowledge that the disabling side effects from the drug class were not “rare” at all, but common and possibly permanent until patient groups, books, videos and lawsuits like Tyszkowski’s reported them. Only in May did the FDA warn that the drug class should only be used as a last resort. In July, it provided language for new label warnings and a medication guide to be given to every patient. Better late than never.
Red Flags Ignored
Fluoroquinolone antibiotics are among the biggest-selling drug classes. Demand for Bayer’s Cipro was so strong after the 9/11 attacks when anthrax-containing letters were sent to media outlets and lawmakers, killing five and infecting 17, daily prescriptions soared to 14,000 a day. Bayer planned to open another plant.
But by 2008, Cipro was under the same cloud as other drugs in its class thanks to an FDA announcement that cautioned fluoroquinolones posed an increased risk of tendinitis and tendon rupture. The FDA warning, which told drug makers to make label changes, said the agency had conducted a new data analysis of tendinitis and tendon ruptures and identified a three times greater risk for patients using fluoroquinolones.
“Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy,” the FDA advised in its statement. “Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.”
The watchdog group Public Citizen called for warnings about the tendinitis and tendon rupture side effects with the drug class as early as 1999 and sued the FDA in 2006 to have warnings added. At the time, 10 years ago, Public Citizen cited 262 cases of tendon ruptures, 258 cases of tendonitis and 274 other cases of other tendon problems. A more recent count in a medical journal revealed there have been 2,495 reports of tendon rupture linked to fluoroquinolones from their respective approvals date through 2012. There were 1,555 for Levaquin (levofloxacin) and 606 for Cipro (ciprofloxacin) said the research.
Tendinitis and tendon ruptures, it turned out, were the tip of the Levaquin and fluoroquinolone iceberg. In 2013, the FDA admitted under pressure from public health officials and patients groups that the “serious side effect of peripheral neuropathy” (nerve damage) can “occur soon after these drugs are taken and may be permanent.” By then, hundreds of lawsuits had charged that warnings falsely claimed that the side effects were “rare” and that symptoms go away on discontinuation. In fact they are often permanent, charge patients and patient groups who are raising awareness, and have coined the term “Fluoroquinolone Toxicity Syndrome.”
And there was more. Fluoroquinolone use is a “major risk factor for development of community and hospital acquired C. difficile infection,” reports the Duke Antimicrobial Stewardship Outreach Network (DASON), the dreaded and tenacious intestinal microbe. The drugs are also linked to mental effects like confusion and hallucinations, says DASON, and a medical journal reportspsychosis. The Journal of the American Medical Association reported that of 4,384 patients diagnosed with retinal detachment, 445 (10 percent) were exposed to a fluoroquinolone in the year before diagnosis.
Other possible fluoroquinolone side effects include liver injury—which caused Trovan (trovafloxacin), a different fluoroquinolone to be withdrawn—and heart problems—which caused the fluoroquinolone Raxar (grepafloxacin) to be withdrawn after heart-related deaths. Omniflox, another fluoroquinolone, was withdrawn from the market after more than 100 patients experienced allergic events, hemolytic anemia and worse. Patients also experienced kidney dysfunction on Omniflox and half needed dialysis. Others suffered liver dysfunction.
Was Former FDA Commissioner Hamburg Culpable?
This spring, a federal lawsuit was filed against former FDA commissioner Margaret Hamburg, her husband, Peter Brown and Johnson & Johnson. It charges the parties sought to inflate Johnson & Johnson stock price by hiding risks linked to its drug, Levaquin. Brown is an executive in the hedge fund Renaissance Technologies which held hundreds of millions of dollars of Johnson & Johnson stock according to news reports.
“While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown’s annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin,” says the suit.
Hamburg left the FDA in 2015 but not before naming Robert Califf FDA Deputy Commissioner for Medical Products and Tobacco. Califf went on to become the new FDA commissioner despite 23 financial links to pharmaceutical companies including board appointments, a conflict-ridden choice which AlterNet told you about earlier this year.
Fluoroquinolones Use in Livestock
As AlterNet has reported, U.S. factory farmers turn nasty when the government tries to take away their antibiotics. Without antibiotics, animals would require more food and more room to move around, eating into profits. In 2008, the egg, chicken, turkey, milk, pork and cattle industries stormed Capitol Hill over the FDA’s attempt to prohibit the use of antibiotics called cephalosporins and they won. Instead, the government backpedaled into its current livestock antibiotic regulatory system which many consider toothless, full of loopholes and an honor system. The use of antibiotics on the farm has actually increased.
After a decade-long battle with Bayer whose fluoroquinolone Baytril (enrofloxacin) was routinely used in poultry, the government managed to ban the antibiotic’s use in poultry water. As with all antibiotics used in livestock, the FDA worried about the development of fluoroquinolone-resistant bacteria sometimes called “superbugs” and the ability to treat human infections.
But fluoroquinolones are still clearly in use on U.S. farms. The USDA’s National Residue Program for Meat, Poultry, and Egg Products which tests for six fluoroquinolones found enrofloxacin (Baytril) and ciprofloxacin (Cipro) residues in meat in 2014, 2013 and 2012—the most recent reports available—and danofloxacin residues in meat in two of the three years. Yes, drugs not even recommended for people are found as residues in U.S. meat.
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