Preview Newsletter
Levaquin Media Report 7/27/16
-
FDA enhances warnings on group of strong antibiotics
Jul 26, 2016 | Reuters
By Dipika Jain and Don Sebastian
The U.S. Food and Drug Administration has enhanced warnings of side effects of a group of strong antibiotics used to treat a variety of respiratory and urinary tract infections and limited their use to patients with no alternatives. -
FDA Strengthens Warning on Powerful Antibiotics
Jul 26, 2016 | NBC News
By Maggie Fox
The Food and Drug Administration strengthened the warnings about one type of antibiotic Tuesday, saying they're too strong to be used for sinus infections, bronchitis and simple urinary tract infections. The drugs are in a class called fluoroquinolones and include levofloxacin (as known as Levaquin) and ciprofloxacin (Cipro). They can cause serious and sometimes permanent side-effects. -
FDA issues updated label warnings for Levaquin, Cipro antibiotics
Jul 26, 2016 | News Net 5 Cleveland
By Ron Regan
The U.S. Food and Drug Administration issued updated warnings on Tuesday for some of the most prescribed antibiotics on the market due to disabling and potentially permanent side effects. -
FDA Strengthens Warnings on Group of Strong Antibiotics
Jul 26, 2016 | WABC
The Food and Drug Administration announced on Tuesday a new set of warnings about a group of commonly used antibiotics. Some of the drugs included in these new enhanced warnings include Cipro, Levaquin, and Avelox. -
Pharmaceutical companies accused of inadequate labeling
Jul 26, 2016 | Pennsylvania Record
By Louie Torres
A couple's lawsuit against Johnson & Johnson, Janssen Research & Development LLC and Janssen Pharmaceuticals Inc. cites alleged breach of implied warranty, failure to warn, fraud, negligence, negligent misrepresentation and product liability. -
FDA issues warning on common antibiotics
Jul 26, 2016 | Greenville Online
By Liv Osby
The FDA on Tuesday issued enhanced warnings about antibiotics called fluoroquinolones, saying their risk outweighs the benefit when used for sinusitis and other minor conditions. Fluoroquinolones include the drugs Cipro, Levaquin, Avelox and Factive. -
FDA Bolsters Warnings About Class of Antibiotics
Jul 26, 2016 | Health Day News
The U.S. Food and Drug Administration announced Tuesday that it's strengthening label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to disabling side effects, including long-term nerve damage and ruptured tendons. -
FDA Updates Warnings For Antibiotics Class
Jul 26, 2016 | Law360
By Emily Field
The U.S. Food and Drug Administration said Tuesday that it has signed off on safety labeling changes for a class of antibiotics known as fluoroquinolones, to bolster warnings about a link with potentially permanent side effects. -
FDA: Limit use of fluoroquinolones
| American Association of Pediatrics
By Melissa Jenco
Fluoroquinolone antibiotics may have serious side effects and should be used sparingly, federal officials warned Tuesday. Such side effects have prompted the Food and Drug Administration (FDA) to issue label changes for such drugs. -
Are You Taking This Dangerous Antibiotic?
Jul 26, 2016 | Alternet
By Martha Rosenberg
“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.” -
FDA updates fluoroquinolone safety warnings
Jul 27, 2016 | Healio
The FDA has approved changes to the labels of several fluoroquinolones warning of several disabling and potentially permanent side effects when taken by mouth or injection, according to an announcement released today. -
FDA: Updated Warnings for Antibiotic Class
Jul 26, 2016 | MPR
The Food and Drug Administration (FDA) has approved changes to the drug labeling for fluoroquinolone antibacterials for systemic use. This class of drugs has been associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system (CNS) that can simultaneously occur in the patient. -
Fluoroquinolone Label Warning Strengthened by FDA
Jul 26, 2016 | Medscape
By Tony Brown
The US Food and Drug Administration (FDA) approved updated labeling for fluoroquinolone antibiotics today to warn against their use in patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, unless those patients have no other treatment options. -
FDA strengthens warnings on class of antibiotics
Jul 26, 2016 | BioPharma Dive
By Nicole Gray
The Food and Drug Administration on Tuesday approved a broader warning label for the entire class of fluoroquinolone antibiotics, following up on a safety alert published in May that cautioned against using the drugs in certain patients. -
45 News Morning
Jul 27, 2016 | LSTC Minneapolis
View clip here: http://beta.criticalmention.com/app/#clip/view/23596340?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019 -
ABC 11 Eyewitness News
Jul 27, 2016 | WTVD Raleigh-Durham
View clip here: http://beta.criticalmention.com/app/#clip/view/23596398?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019 -
Cleveland 19 News on 43
Jul 26, 2016 | WUAB 18 Cleveland
View clip here: http://beta.criticalmention.com/app/#clip/view/23596421?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019 -
10News
Jul 26, 2016 | KGTV San Diego
View clip here: http://beta.criticalmention.com/app/#clip/view/23596446?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019 -
8 News
Jul 26, 2016 | WRIC (ABC) Richmond
View clip here: http://beta.criticalmention.com/app/#clip/view/23596545?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019 -
The NOW
Jul 26, 2016 | WES (ABC) Cleveland
View clip here: http://beta.criticalmention.com/app/#clip/view/23596578?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019 -
News 12 Long Island
Jul 27, 2016 | N12LI New York
View clip here: http://beta.criticalmention.com/app/#clip/view/23596814?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019
National Coverage
Local Coverage
Trade Coverage
Broadcast Coverage
-
FDA enhances warnings on group of strong antibiotics
Jul 26, 2016 | Reuters
By Dipika Jain and Don Sebastian
The U.S. Food and Drug Administration has enhanced warnings of side effects of a group of strong antibiotics used to treat a variety of respiratory and urinary tract infections and limited their use to patients with no alternatives.
The antibiotics known as fluoroquinolones include Johnson & Johnson's Levaquin, Bayer's Cipro extended-release tablets and Merck Inc's Avelox. (bit.ly/2a8Xvup)
The FDA added a box warning to the antibiotics in July 2008 to inform users about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed.
The box warning was updated on Tuesday to highlight the disabling and potentially permanent side effects of the drugs.
The regulator said in May that the side effects of the antibiotics outweighed its benefits. (bit.ly/1TdtpSy)
-
FDA Strengthens Warning on Powerful Antibiotics
Jul 26, 2016 | NBC News
By Maggie Fox
The Food and Drug Administration strengthened the warnings about one type of antibiotic Tuesday, saying they're too strong to be used for sinus infections, bronchitis and simple urinary tract infections.
The drugs are in a class called fluoroquinolones and include levofloxacin (as known as Levaquin) and ciprofloxacin (Cipro). They can cause serious and sometimes permanent side-effects.
"While these drugs are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system," the agency said in a statement.
Related: Feared Superbug Gene Showed Up in U.S. Last Year
"These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent."
The drugs are worthwhile to use for potentially fatal infections such as plague, anthrax and some types of bacterial pneumonia but not for the more minor stuff, FDA added.
"FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive)," the statement said.
"The labeling changes include an updated Boxed Warning and revisions to the Warnings and Precautions section of the label about the risk of disabling and potentially irreversible adverse reactions that can occur together."
-
FDA issues updated label warnings for Levaquin, Cipro antibiotics
Jul 26, 2016 | News Net 5 Cleveland
By Ron Regan
WASHINGTON D.C. - The U.S. Food and Drug Administration issued updated warnings on Tuesday for some of the most prescribed antibiotics on the market due to disabling and potentially permanent side effects.
The FDA approved safety labeling changes for a class of antibiotics called fluoroquinolones that include popular drugs like Cipro, Levaquin and Avelox.
The enhanced warnings include an updated "Boxed Warning," often called black box warnings and revisions to the warnings and precautions sections.
The updated warnings come in the wake of an exclusive 5 On Your Side investigation in July 2015 that revealed disabling side effects involving tendons, joints and nerve damage .
The updated warnings include alerting patients that "serious side effects generally outweigh the benefits" for patients with acute bacterial sinusitis and uncomplicated urinary tract infections.
The FDA determined that fluoroquinolones should be "reserved for use in patients" who have no alternative treatment options.
-
FDA Strengthens Warnings on Group of Strong Antibiotics
Jul 26, 2016 | WABC
The Food and Drug Administration announced on Tuesday a new set of warnings about a group of commonly used antibiotics.
Some of the drugs included in these new enhanced warnings include Cipro, Levaquin, and Avelox.
They're part of the fluoroquinolones family of antibiotics that are usually used to treat urinary tract and respiratory infections.
The FDA says that they could cause debilitating permanent damage to muscles, joints, and nerves.
The agency says use should be restricted to only the most acute illnesses where there are no other options. -
Pharmaceutical companies accused of inadequate labeling
Jul 26, 2016 | Pennsylvania Record
By Louie Torres
A couple's lawsuit against Johnson & Johnson, Janssen Research & Development LLC and Janssen Pharmaceuticals Inc. cites alleged breach of implied warranty, failure to warn, fraud, negligence, negligent misrepresentation and product liability.
Tony Brown Sr. and Elizabeth Brown filed a complaint on July 13 in the U.S. District Court for the Eastern District of Pennsylvania against the defendants, alleging that they failed to provide proper warnings about taking Levaquin.
According to the complaint, the plaintiffs allege that in February 2004, one plaintiff was diagnosed with peripheral neuropathy after Levaquin was prescribed. The plaintiffs hold the defendants responsible because they allegedly failed to provide adequate warning on Levaquin's label regarding the potential side effects of the drug.
The plaintiffs request a trial by jury and seek general and special damages, all medical expenses, interest, a full refund of all purchase costs for FLQ drugs, compensatory damages, consequential damages, punitive damages, court costs and any further relief this court grants.
-
FDA issues warning on common antibiotics
Jul 26, 2016 | Greenville Online
By Liv Osby
The FDA on Tuesday issued enhanced warnings about antibiotics called fluoroquinolones, saying their risk outweighs the benefit when used for sinusitis and other minor conditions.
Fluoroquinolones include the drugs Cipro, Levaquin, Avelox and Factive.
Their use is associated with “disabling and potentially irreversible” side effects involving tendons, muscles, joints, nerves and the central nervous system, such as peripheral neuropathy, which can affect movement or function.
As a result, the FDA concluded that they should not be used for bacterial sinusitis, acute chronic bronchitis and uncomplicated urinary tract infections unless there are no other treatment options.
The drugs, FDA said, should be reserved for serious bacterial infections such as anthrax, plague and pneumonia where the benefits outweigh the risks.
According to an FDA safety notice, patients taking these antibiotics should contact their doctor immediately if they experience tendon, joint and muscle pain; a tingling sensation; confusion or hallucinations.
“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Dr. Edward Cox of the FDA’s Center for Drug Evaluation and Research. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”
-
FDA Bolsters Warnings About Class of Antibiotics
Jul 26, 2016 | Health Day News
The U.S. Food and Drug Administration announced Tuesday that it's strengthening label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to disabling side effects, including long-term nerve damage and ruptured tendons.
The agency also cautioned that these bacteria-fighting drugs -- including levofloxacin (Levaquin) and ciprofloxacin (Cipro) -- shouldn't be prescribed for sinusitis, chronic bronchitis or simple urinary tract infections unless no other treatments options exist.
"Fluoroquinolones have risks and benefits that should be considered very carefully," Dr. Edward Cox said in an FDA news release. He's director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research.
"It's important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use," Cox said.
A safety review revealed that potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system can occur hours or weeks after exposure to fluoroquinolone pills or injections. Also, two or more serious side effects can occur together, the FDA said.
Because of this, the FDA recommends reserving these antibiotics for serious bacterial infections, such as anthrax, plague and bacterial pneumonia.
In these cases, "the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option," the agency said.Advertisement
Besides Cipro and Levaquin, other fluoroquinolones include moxifloxacin (Avelox), ofloxacin (Floxin) and gemifloxacin (Factive).
The new labeling action will include an updated boxed warning and revisions to the Warnings and Precautions section of the label. Also, a medication guide that patients receive describes the safety issues tied to these drugs, the agency said.
The FDA has reported concerns about fluoroquinolones since 2008. At that time, it added a boxed warning because of increased risk of tendinitis and tendon rupture.
Almost three years later, the FDA warned that the drugs could worsen symptoms of the neuromuscular disease myasthenia gravis. The potential for serious nerve damage (irreversible peripheral neuropathy) was detailed in 2013.
Finally, last year an FDA advisory committee said uncomplicated sinus, urinary and bronchial infections should be treated with other options.
-
FDA Updates Warnings For Antibiotics Class
Jul 26, 2016 | Law360
By Emily Field
The U.S. Food and Drug Administration said Tuesday that it has signed off on safety labeling changes for a class of antibiotics known as fluoroquinolones, to bolster warnings about a link with potentially permanent side effects.
That class of antibiotics kills or stops bacteria from growing. But while the drugs effectively treat serious infections, the FDA said, a recent safety review of oral and injectable fluoroquinolones uncovered an association with side effects involving the central nervous system, muscles, tendons and joints. Those side effects can happen hours to weeks after exposure to the antibiotics and can be irreversible, the regulator said.
The changes to the label include an updated box warning and revisions to the warnings and precautions section of the label about such risks, according the FDA. Patient medication guides will also describe these risks.
Since the risk of side effects generally outweighs the benefits for treating patients with acute bacterial exacerbations of chronic bronchitis and uncomplicated urinary tract infections, the FDA said, fluoroquinolones should be used for patients with those illnesses only when they do not have any alternative treatment options.
For other serious bacterial infections such as anthrax, plague and pneumonia, fluoroquinolones can remain an option for treatment, the FDA said.
“Fluoroquinolones have risks and benefits that should be considered very carefully,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”
Brand-name fluoroquinolones include Avelox, which is marketed by Merck & Co. Inc., as well asBayer Corp.'s Cipro and Johnson & Johnson’s Levaquin, among others.
The label change follows a May advisory from the agency against the systemic use of this class of antibiotics for treating certain infections and a recommendation that the labels be changed.
The antibiotic class has been the subject of a number of lawsuits.
Earlier this year, Judge Jacqueline F. Allen denied a bid to consolidate 32 cases filed in the Philadelphia Court of Common Pleas against Bayer, Merck and others. The plaintiffs in those cases have argued that the drugmakers hid the risk of permanent nerve damage resulting from the use of fluoroquinolones and seek mass tort designation for their claims.
In January in Illinois, U.S. District Judge Manish S. Shah denied Johnson & Johnson’s bid to dismiss a suit brought by a man blaming Levaquin for a range of serious physical ailments.
The plaintiff in that suit has sought to hold J&J and subsidiary Janssen Pharmaceuticals Inc. responsible for allegedly failing to adequately test the drug, safely manufacture it or warn consumers of its risks.
He allegedly had taken Levaquin for five days in October 2010 to treat an infection. Between then and the start of 2011, he says, he began to experience a host of physical problems, including issues with his tendons and joints, as well as neurological and gastrointestinal disturbances.
A Belgian doctor first established a link between the drugs and permanent nerve damage in 1992. In 2002, the FDA put Bayer on notice that numerous reports suggested such a relationship. -
FDA: Limit use of fluoroquinolones
| American Association of Pediatrics
By Melissa Jenco
Fluoroquinolone antibiotics may have serious side effects and should be used sparingly, federal officials warned Tuesday.
Such side effects have prompted the Food and Drug Administration (FDA) to issue label changes for such drugs.
“Fluoroquinolones have risks and benefits that should be considered very carefully,” Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”
Side effects from fluoroquinolones may be “disabling and potentially permanent” and include tendon rupture, muscle or joint pain, neuropathy, depression and hallucinations, according to the FDA. Patients may experience more than one of these effects, which can happen within hours or weeks.
The new warnings instruct doctors to prescribe fluoroquinolones as a last resort for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections, according to the FDA. However, they still may be appropriate for more serious infections like plague or bacterial pneumonia.
The warnings apply to levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive), which already carry boxed warnings and other precautions.
Patients should contact their doctor if they experience side effects like unusual joint pain, muscle weakness, numbness or hallucinations.
-
Are You Taking This Dangerous Antibiotic?
Jul 26, 2016 | Alternet
By Martha Rosenberg
“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,” they 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 from 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 Johnson & Johnson, its manufacturer, 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 this summer did the FDA warn that the drug class should only be used as a last resort. Thanks for that.
Red Flags Ignored
Fluoroquinolone antibiotics have been 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, ten 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 to the Levaquin and fluoroquinolone iceberg. 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 reports psychosis. 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 Dr. 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, M.D. 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 in2014, 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.
-
FDA updates fluoroquinolone safety warnings
Jul 27, 2016 | Healio
The FDA has approved changes to the labels of several fluoroquinolones warning of several disabling and potentially permanent side effects when taken by mouth or injection, according to an announcement released today.
The update — which will apply to Avelox (moxifloxacin, Bayer HealthCare Pharmaceuticals), standard- and extended-release Cipro (ciprofloxacin, Bayer HealthCare Pharmaceuticals), Factive (gemifloxacin, LG Life Sciences), Levaquin (levofloxacin, Johnson & Johnson) and ofloxacin — was implemented due to associations with tendon, muscle, joint, nerve and central nervous system disabilities that could occur together in the same patient and be permanently debilitating, according to the release. The FDA will revise the boxed warning for these fluoroquinolones, as well as other parts of the drug label such as the “Warnings and Precautions” and “Medication Guide” sections.
Because of these risks and other cardiac, dermatologic and hypersensitivity reactions, the FDA recommends that fluoroquinolone use be reserved for patients with no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, or for serious infections where treatment benefits outweigh the risk for side effects.
According to the release, the FDA “is continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.”
-
FDA: Updated Warnings for Antibiotic Class
Jul 26, 2016 | MPR
The Food and Drug Administration (FDA) has approved changes to the drug labeling for fluoroquinolone antibacterials for systemic use. This class of drugs has been associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system (CNS) that can simultaneously occur in the patient.
Currently available fluoroquinolones include: Avelox(moxifloxacin), Cipro (ciprofloxacin), Cipro XR (ciprofloxacin extended-release), Factive (gemifloxacin), Levaquin(levofloxacin), and Ofloxacin.
Fluoroquinolone use should be reserved for patients who have no treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risks of these serious adverse events generally outweigh the benefits. In cases where the benefits of fluoroquinolones outweigh the risks, it is appropriate for this drug class to remain a treatment option.
Patients that experience serious side effects such as unusual joint or tendon pain, muscle weakness, a "pins and needles" tingling or prickling sensation, arm/leg numbness, confusion, and hallucinations, are urged to contact their healthcare provider immediately. These reactions can occur within hours to weeks after initiating fluoroquinolone treatment.
Healthcare professionals should not prescribe systemic fluoroquinolones to patients who have other therapeutic options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections due to the risks outweighing the benefits. If a patient experiences serious side effects while taking fluoroquinolones, treatment should be immediately discontinued and switched to a non-fluoroquinolone antibacterial to complete the treatment course. In addition, fluoroquinolones should be avoided in patients who have previously experienced serious fluoroquinolone-associated adverse reactions.
The FDA has revised the Boxed Warning to address these safety issues and a new warning has been added along with updates to other sections, including the Medication Guide. There is already a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. Other warnings on the labeling include risks of peripheral neuropathy, CNS effects (eg, psychosis, anxiety, insomnia, depression), and cardiac (eg, QT prolongation), dermatologic, and hypersensitivity reactions. The Indications and Usage section now contains a new Limitations of Use statement to reserve fluoroquinolones for patients who do not have other available treatment for the listed conditions. The Medication Guide describes the safety issues associated with these drugs and should be given to the patient with each prescription.
The FDA had reviewed data from placebo-controlled trials of various antibacterial agents in patients with the aforementioned conditions as well as post-marketing reports of adverse reactions associated with fluoroquinolones. A search of the FAERS database (November 1997–May 2015) found 178 cases of healthy patients who took oral fluoroquinolones for those conditions and developed disabling and potentially irreversible adverse reactions. The majority of the reactions affected the musculoskeletal system, peripheral nervous system, and CNS.
Previously, the FDA had issued safety information related to fluoroquinolones in July 2008, August 2013, and May 2016. The Agency is continuing to evaluate safety issues with fluoroquinolones as part of the ongoing review and will update the public if more data becomes available.
For more information visit FDA.gov.
-
Fluoroquinolone Label Warning Strengthened by FDA
Jul 26, 2016 | Medscape
By Tony Brown
The US Food and Drug Administration (FDA) approved updated labeling for fluoroquinolone antibiotics today to warn against their use in patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, unless those patients have no other treatment options.
The new labeling strengthens warnings about the risks for disabling and potentially permanent adverse effects including tendonitis and tendon rupture, central nervous system effects, myasthenia gravis exacerbation, peripheral neuropathy, prolongation of the QT interval, torsades de pointes, and phototoxicity. These effects can occur hours to weeks after exposure and can occur together.
"Fluoroquinolones have risks and benefits that should be considered very carefully," Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "It's important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use."
Fluoroquinolones are effective in treating serious bacterial infections, but the FDA's Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee determined on November 5, 2015, that their risks outweigh their benefits in patients with uncomplicated infections who have other treatment options. The panel was particularly concerned for the potential of more than one adverse effect to occur together.
The FDA released a drug safety communication on May 12, 2016, saying that clinicians should reserve fluoroquinolones for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have no other treatment options, because of the potential for these devastating adverse effects.
The benefits of fluoroquinolone antibiotics outweigh the risks in patients with certain serious bacterial infections, including anthrax, plague, and bacterial pneumonia, and they should continue to be available for those patients, the FDA said in the news release.
FDA-approved fluoroquinolone antibiotics include levofloxacin (Levaquin, Janssen Pharmaceuticals, Inc), ciprofloxacin (Cipro, Bayer Healthcare), ciprofloxacin extended-release tablets, moxifloxacin (Avelox, Merck), ofloxacin (available only as a generic formulation), and gemifloxacin (Factive, LG Life Sciences).
The labeling changes include updates to the Boxed Warning and a revised Warnings and Precautions section describing the risk for "disabling and potentially irreversible adverse reactions that can occur together," the FDA said in its statement. The label also warns clinicians to reserve fluoroquinolones for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, as well as no other treatment options. The patient Medication Guide describes these safety issues and is required to be given to patients with each fluoroquinolone prescription.
-
FDA strengthens warnings on class of antibiotics
Jul 26, 2016 | BioPharma Dive
By Nicole Gray
Dive Brief:The Food and Drug Administration on Tuesday approveda broader warning label for the entire class of fluoroquinolone antibiotics, following up on a safetyalert published in May that cautioned against using the drugs in certain patients. Fluoroquinolones should now be reserved for use only in patients who have no alternative treatments for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA said.In those patients, the risks of "disabling and potentially permanent" side effects outweigh the benefits of use. Fluoroquinolones have previously been linked to increased risk of tendon rupture and serious nerve damage.Dive Insight:Fluoroquinlones are a class of strong antibiotics and include Johnson & Johnson's Levaquin, Bayer's Cipro, Merck's Avelox and LG Life Sciences' Factive. All four are available in generic forms.
In 2008, the FDA required the drugs to carry a boxed warning cautioning of the risk of tendinitis and tendon rupture. That warning was expanded in February 2011 to include the risk of worsening symptoms for those with myasthenia gravis, and again in August 2013 for the risk of serious and potentially irreversible nerve damage.
An advisory panel determined last November the risk of these side effects occurring together and leaving lasting damage was too high to use fluoroquinolones for uncomplicated infections.
The FDA agreed and has now updated the warning labels to reflect the potential for multiple side effects occurring together and adding a limitation-of-use statement.
However, in the case of certain serious bacterial infections, such as anthrax, plague and bacterial pneumonia "the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option."
-
Jul 27, 2016 | LSTC Minneapolis
View clip here: http://beta.criticalmention.com/app/#clip/view/23596340?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019
Rough transcript: The u.s. food and drug administration approved safety labeling changes for fluoroquinolones. we first told you about the side effects last year, several patients in minnesota told our reporter joe augustine that they suffered severe tendon damage after taking the drug, and they now struggle to even walk. In may the fda started warning patients that serious side effects generally outweighed the benefits for patients suffering from sinus infection, bronchitis, or urinary tract infections.
-
Jul 27, 2016 | WTVD Raleigh-Durham
View clip here: http://beta.criticalmention.com/app/#clip/view/23596398?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019
Rough transcript: Now update on a popular antibiotic given to you by doctors now comes with a strong warning from the FDA. The FDA says the drugs known as levaquin and cipro are too strong to be used for illnesses like sinus infection and -- bronchitis and simple urinary tract infections. The enhanced warnings form the FDA include a black box warning is the most serious warning a drug can carry. Our i team first told you about serious side effects from levaquin involving tendons, joint and nerve damage. The f.d.a. says the drugs should only be used for potentially fatal infections like the plague, anthrax, and fatal pneumonia.
-
Jul 26, 2016 | WUAB 18 Cleveland
View clip here: http://beta.criticalmention.com/app/#clip/view/23596421?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019
Rough transcript: a major labeling change for some antibiotics. the fda is requiring companies to change their warning labels to let the customers know that the side effects -- some of the side effects -- of the medication could be potentially permanent. what does this mean and what are we talking about? first the antibiotics we are talking about here are called floroquionolones -- is used for sinus infections and bronchitis and uncomplicated urinary tract infections. the side effects that could be permanent are kind of pretty bad. it is damage to the tendons, muscles, joints, nerves and the central nervous system. and now let's get to the antibiotics. if you take any of these and are suffering from things like joint pain and muscle weakness or you get tingling, pins and needles, you need to call your doctor right away. the fda is saying cipro is one of them. if you take avalox is one. the third is factiv and last but not least, another drug is levaquin. that's actually a pretty common drug used to treat. again, nothing emergency earth shattering, but interesting when the fda makes a recommendation that the labels need to be changed now. we heard about drugs with the side effects, but the fact that they can be permanent and that outweighs the benefit of these drugs is why the fda is recommending these changes.
-
Jul 26, 2016 | KGTV San Diego
View clip here: http://beta.criticalmention.com/app/#clip/view/23596446?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019
Rough transcript: the fda is strengthening its warning on a powerful antibiotic used to treat sinus and urinary tract infection. starting today boxes of johnson and johnson brand levaquin and cipro pills will have obvious warnings on the boxes. it will highlight the potentially permanent risk of tendinitis which is inflammation in the tissues. the FDA said in May that the side effects of the antibiotics outweighed the benefits.
-
Jul 26, 2016 | WRIC (ABC) Richmond
View clip here: http://beta.criticalmention.com/app/#clip/view/23596545?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019
Rough transcript: after a series of 8news investigations, the fda approves labeling changes for commonly prescribed antibiotics..cipro, levaquin and avelox. those floroquionolones are no longer recommended for bactercial infections like bronchitis and urinary tract infections. 8news spent more than a year exposing devastating side effects from cipro and levaquin including tendon ruptures, memory loss and permanent damage to the central nervous system. the fda says the risks outweigh the benefits when treating those infections.
-
Jul 26, 2016 | WES (ABC) Cleveland
View clip here: http://beta.criticalmention.com/app/#clip/view/23596578?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019
Rough transcript: and just in, the fda recently announced new warnings in the wake of an exclusive 5 on your side Chief investigator Ron Regan joins us live now and Ron the fda has an update. reporter: that's right the FDA today approved new safety label changes for drugs like cipro and levaquin. they're part of a family of drugs called floroquinolones often predescribed for sinus and urinary tract infections. our exclusive report dug into the FDAs own database and found at least 3,000 patients whose deaths was linked to the drug. another 200,000 complaints of side effects, including kidney infections and nerve damage. well today, the fda updated what is called the black box warning. it includes advising patients that risks outweigh the benefits for many and should be used only when there is no other option.
-
Jul 27, 2016 | N12LI New York
View clip here: http://beta.criticalmention.com/app/#clip/view/23596814?token=8becec9c-e3ba-4cdd-b13c-48334a7cb019
Rough transcript: on the health beat - strong new health warnings for long islanders taking popular antibiotics including levaquin, cipro and avelox. the fda says the drugs are too strong to be taken for simple ailments like sinus infections, urinary tract infections or bronchitis. it's issued a new warning saying they should only be taken when there's no other option. they cite the risk of permanent damage to muscles and nerves.
National Coverage
Local Coverage
Trade Coverage
Broadcast Coverage
Add recipients
Suggested