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FDA Requires Stronger Warnings for Antibiotics’ Side Effects
May 12, 2016 | Wall Street Journal
By Thomas Burton
The Food and Drug Administration said Thursday it will require heightened warnings about serious and sometimes disabling side effects from the commonly used class of antibiotics called fluoroquinolones. -
FDA Orders Stronger Warning Labels For Antibiotic Class
May 12, 2016 | Law360
By John Kennedy
The U.S. Food and Drug Administration on Thursday advised against the systemic use of a class of antibiotics known as fluoroquinolones for the treatment of certain infections in patients who have other treatment options, ordering the drug labels to be updated accordingly. -
FDA Advises Against Fluoroquinolone Antibiotic Use for Uncomplicated Infections
May 12, 2016 | Pharmacy Times
By Allison Gilchrist
Serious side effects associated with fluoroquinolones generally outweigh the antibiotics’ benefits for patients with uncomplicated infections like sinusitis and bronchitis, the FDA announced. -
FDA recommends limiting use of fluoroquinolones
May 12, 2016 | Healio
The FDA issued a safety alert today recommending that health care professionals treating patients with sinusitis, bronchitis and uncomplicated urinary tract infections only prescribe fluoroquinolones to those patients who have no other alternative treatment options, as the adverse events related to the drugs for these conditions generally outweigh the benefits. -
Huffington Post: Why the FDA’s New Warning Labels for Popular Antibiotics Matter
May 13, 2016 | Huffington Post
By Elizabeth S Mitchell
On October 11, 2014, just before my 28th birthday, I was jolted awake in the middle of the night by the sensation that bees were stinging me from head to toe. Tingling sensations crept all over my body; phantom pins and needles pricked and burned my hands and feet; roving numbness caused me to lose sensation in one finger, then one toe, then one earlobe; and what felt like icy water slid up and down my limbs. When I tried to get out of bed, my legs would not support my weight, and I crumpled onto the floor. As I hoisted myself back into bed, all of my joints popped and crunched with the exertion, random stabbing pains sliced through my neck and shoulders, and my muscles — all of my muscles — in my jaw, my abdomen, my feet, were aching as though I had the flu. Once lying still again, I noticed that, one by one, my muscles were twitching — first in my right toe, then in my cheek, then my left eye. -
Daily Roundup
May 13, 2016 | STAT Pharmalot, Pharmalitte
By Ed Silverman
included in the daily roundup of pharmaceutical news. Relevant sections pasted below. -
FDA warns about Cipro, other antibacterials Modern Medicine
May 13, 2016 | Modern Medicine
By Christine Blank
FDA issued a new warning about potentially serious side effects associated with fluoroquinolone antibacterial drugs. Affected brands include Cipro, Levaquin, Avelox, Factive and Moxaflaxacin injection, as well as the generic Ofloxacin. -
FDA issues major drug warning for popular antibiotic used by millions
May 12, 2016 | ABC 5- NewsNet5
An exclusive 5 On Your Side investigation has contributed to a major drug warning connected to one of the nation's most prescribed antibiotics. -
FDA: Specific Antibiotic Should Only Be Used As Last Resort
May 12, 2016 | ABC 5- Minneapolis, MN
A popular and powerful antibiotic known to cause severe tendon damage in patients should only be used as a last resort to treat certain types of infections, the Food and Drug Administration (FDA) announced Thursday. -
FDA announces antibiotic label changes following Call 6 report
May 13, 2016 | The Indy Channel- ABC 6
The U.S. Food and Drug Administration has announced labeling changes to antibacterial drugs called fluoroquinolones following multiple Call 6 Investigations into safety issues. -
FDA: Label changes for fluoroquinolones to include warnings of serious side effects
May 12, 2016 | ABC News 8-WRIC
RICHMOND, Va. (WRIC) — On Thursday, the FDA announced that it is now requiring label changes for antibacterial drugs called fluoroquinolones, including an updated boxed warning and Medication Guide, and advising that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. -
FDA changes warning label on popular antibiotics
May 13, 2016 | WSOC TV
By Alexa Ashwell
Last year Channel 9 investigated patients concerned that popular antibiotics could have having devastating side effects. -
FDA advises restricting use of fluoroquinolones for certain uncomplicated infections
May 13, 2016 | American Pharmacists' Association
FDA warned Thursday that the serious adverse effects associated with fluoroquinolone antibacterial drugs "generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options." -
Levaquin
May 12, 2016 | WEWS (ABC), Cleveland, OH
(Loose transcript) Major drug warning issued tonight, prompted by an exclusive 5 on your side investigation. The Cipro and Levaquin, powerful antibiotics, your investigation has prompted big changes by the FDA.
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FDA Requires Stronger Warnings for Antibiotics’ Side Effects
May 12, 2016 | Wall Street Journal
By Thomas Burton
The Food and Drug Administration said Thursday it will require heightened warnings about serious and sometimes disabling side effects from the commonly used class of antibiotics called fluoroquinolones.
That class of medications is mostly sold now as generic drugs. But well-known brand names include Bayer AG’s Cipro, generically called ciprofloxacin; and Johnson & Johnson’s Levaquin, or levofloxacin. The class of antibiotics has been marketed for about three decades.
The federal agency is calling for an updated boxed warning, informing patients that the serious side effects of the medicines generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections, if patients have other treatment options.
The side effects can involve damage to tendons, muscles, joints, nerves and the central nervous system. The agency’s action follows a study of the issue by the FDA’s Office of Surveillance and Epidemiology, which concluded as early as 2013: “We continue to find an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy.”
The cases evaluated by that office included weakness, numbness, pain, discomfort, burning and tingling. This research also disclosed the case of a man who suffered a hypersensitivity reaction while taking levofloxacin and died.
Another FDA review reported a risk of cardiovascular disease and of tendon rupture.
The FDA in August 2013 issued a public warning. But it subsequently concluded that a range of seemingly unconnected problems can occur with people taking the drugs. So the agency convened a safety panel that met last November, which strongly advised the FDA to issue the more stringent warnings.
Johnson & Johnson said it is studying the FDA’s statement and noted that Levaquin has been used for more than 20 years. Bayer said it is aware of the FDA statement and will work closely with the FDA on the topic.
Fluoroquinolones are very commonly prescribed. IMS Health, the drug-research firm, said there were a total of more than 36 million prescriptions written in 2014, but wasn’t able immediately to provide a more recent figure.
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FDA Orders Stronger Warning Labels For Antibiotic Class
May 12, 2016 | Law360
By John Kennedy
The U.S. Food and Drug Administration on Thursday advised against the systemic use of a class of antibiotics known as fluoroquinolones for the treatment of certain infections in patients who have other treatment options, ordering the drug labels to be updated accordingly.
The serious side effects associated with fluoroquinolone use generally outweigh the benefits for patients with alternative treatment options, the FDA said. Those side effects include disabling and potentially permanent damage to tendons, muscles, joints, nerves and the central nervous system. The agency is requiring that drug labels and medication guides for all such drugs be updated to reflect the new safety information.
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 announcement comes after an FDA advisory committee ruled in November that fluoroquinolones lack adequate safety warnings. The committee found in a series of unanimous and near-unanimous votes that the labels lack strong enough warnings for the treatment of acute bacterial sinusitis, urinary tract infections and acute bacterial problems that complicate chronic bronchitis in patients with chronic obstructive pulmonary disease.
Patients experiencing any serious side effects while taking fluoroquinolone medications, including tendon, joint and muscle pain, a “pins and needles” tingling sensation, confusion or hallucinations, should notify their doctors immediately. Health care professionals, meanwhile, should stop using the drug if a patient reports such symptoms and switch to a non-fluoroquinolone drug to complete treatment, the FDA said.
The FDA said Thursday that it's continuing to investigate safety issues related to fluoroquinolones and will update the public if additional information becomes available.
The antibiotic class has been the subject of a number of lawsuits.
Earlier this year, Pennsylvania state 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 were seeking mass tort designation for their claims.
In January, U.S. District Judge Manish S. Shah, in Illinois, 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 Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. responsible for allegedly failing to adequately test the drug, manufacture it safely or warn consumers of its risks.
He said he took Levaquin for five days in October 2010 to treat an infection. Between then and the start of 2011, he said, 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.
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FDA Advises Against Fluoroquinolone Antibiotic Use for Uncomplicated Infections
May 12, 2016 | Pharmacy Times
By Allison Gilchrist
Serious side effects associated with fluoroquinolones generally outweigh the antibiotics’ benefits for patients with uncomplicated infections like sinusitis and bronchitis, the FDA announced.
During a drug safety review, the FDA determined that systemic use of fluoroquinolones is associated with “disabling and potentially permanent serious side effects that can occur together” involving the tendons, muscles, joints, nerves, and central nervous system, such as a torn Achilles tendon.
The alert comes a year after the FDA convened an advisory committee to review the risk-benefit balance for fluoroquinolones. The committee determined that the risk wasn’t worth the potential benefit for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections, for which other treatment options exist.
Labels and medication guides for all fluoroquinolones will be updated to reflect the FDA’s findings.
Fluoroquinolones, which includes ciprofloxacin (Cipro), are bactericidal agents that exhibit concentration-dependent killing against a broad spectrum of pathogens. They also demonstrate excellent tissue penetration, with their concentrations in tissue often exceeding those in plasma. -
FDA recommends limiting use of fluoroquinolones
May 12, 2016 | Healio
The FDA issued a safety alert today recommending that health care professionals treating patients with sinusitis, bronchitis and uncomplicated urinary tract infections only prescribe fluoroquinolones to those patients who have no other alternative treatment options, as the adverse events related to the drugs for these conditions generally outweigh the benefits.
During a safety review, the FDA determined that fluoroquinolones taken as tablets, capsules and injectables may cause disabling and potentially permanent adverse events involving the tendons, muscles, joints, nerves and central nervous system. The agency now requires all drug labels and medication guides for fluoroquinolones be updated to specify this information.
Patients are advised to alert their physicians if they experience signs and symptoms of adverse events related to fluoroquinolones, such as tendon, joint and muscle pain, “pins and needles” tingling sensations, confusion or hallucinations. Health care providers are urged to terminate systemicfluoroquinolone treatment if their patients report these events and switch to a nonfluoroquinolone regimen.
In July 2008, the FDA required drug labels and medication guides for all fluoroquinolones be updated to include the risk for peripheral neuropathy in patients taking the drugs. It expanded this recommendation in August 2013 to include the increased risk for tendinitis and tendon rupture.
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Huffington Post: Why the FDA’s New Warning Labels for Popular Antibiotics Matter
May 13, 2016 | Huffington Post
By Elizabeth S Mitchell
On October 11, 2014, just before my 28th birthday, I was jolted awake in the middle of the night by the sensation that bees were stinging me from head to toe. Tingling sensations crept all over my body; phantom pins and needles pricked and burned my hands and feet; roving numbness caused me to lose sensation in one finger, then one toe, then one earlobe; and what felt like icy water slid up and down my limbs. When I tried to get out of bed, my legs would not support my weight, and I crumpled onto the floor. As I hoisted myself back into bed, all of my joints popped and crunched with the exertion, random stabbing pains sliced through my neck and shoulders, and my muscles — all of my muscles — in my jaw, my abdomen, my feet, were aching as though I had the flu. Once lying still again, I noticed that, one by one, my muscles were twitching — first in my right toe, then in my cheek, then my left eye.
As I lay there in the dark, my mind whirling to comprehend what was happening, I thought about the past few days, attempting to pinpoint a cause. The only thing I had done differently was take the prescribed dose of antibiotic Ciprofloxacin (in the fluoroquinolone family) for what my doctor’s vacation stand-in suspected to be a UTI based on symptoms and white cells in the urine — I later found out that no culture was actually done.
At first, the idea of an antibiotic being responsible for the bizarre symptoms I was experiencing seemed laughable. But as I lay in bed after only three days on the drug, my whole body in revolt, I reached for my phone in search of answers. The phone itself seemed to weigh a hundred pounds, and my wrist gave out upon trying to lift it. I finally managed to situate it in such a way that allowed my aching fingers to type “adverse reaction to Cipro” in the search bar.
What popped up was terrifying.
Countless stories of previously healthy people who had been permanently disabled, ended up in wheel chairs, experienced chronic pain, lost their cognitive abilities, developed psychiatric problems — all from an antibiotic prescribed (in most cases) for minor infections — filled my iPhone’s tiny screen.
How is this possible? I thought. The reactions seemed so unrelated and so numerous, affecting virtually every system of the body. The one thing they all had in common was that they were utterly devastating. From an antibiotic?
The disbelief quickly dissolved into the panicked realization that what I was experiencing may only be the beginning. I called my doctor’s emergency number, and the on-call physician told me to stop the medication and come in first thing in the morning.
This was the beginning of my journey as a “Floxie,” the nickname given to those suffering from what the FDA now calls Fluoroquinolone Associated Disability or FQAD.
I was diagnosed with the following conditions: widespread muscle deterioration; body-wide tendon damage (which put me at risk for rupture); damage to my peripheral nervous system resulting in neuropathy (which caused chronic pain, extreme weakness, and severely limited mobility); and damage to my central nervous system resulting in chronic migraine and impaired GABA function.
For the first few months after being “floxed,” I was almost completely bed-ridden. I could barely walk from my bedroom to my bathroom, and I often needed help dressing and undressing, cutting food, washing my hair, and lifting anything heavier than leaf of paper. My teaching job found long-term substitutes for my classes, and I was out of work until December, when I went back to work VERY part time (only one class). Being around my students again brightened my outlook immeasurably, but cutting so far back on work had drastic financial consequences, as my husband (also a teacher) and I were still paying rent, heat, etc. We have since moved out of our apartment and back in with my family while we get back on our feet.
The rest of the healing process has been up and down, learning by trial and sometimes-disastrous-error what helps and what hurts (if you would like to read these details of my story, learn more about the condition, or read about what has helped me cope, please visit my more in-depth post on the Floxie Hope website). I am now teaching full time again, and while my “good days” once meant brushing my own hair, they now entail climbing mountains — literally. But chronic migraine, unpredictable flares of pain, fatigue, and mobility issues, and an inability to tolerate even “minor substances” like over-the-counter painkillers, caffeine, or alcohol, are a part of my daily life — and I am one of the very lucky ones.
Fluoroquinolone antibiotics can and do save lives. They were developed to treat serious illnesses like Anthrax and antibiotic-resistant pneumonia. And in cases like those, risking lifelong disability is likely worth it. However, according to the CDC, this class of antibiotics is the fourth most popular in the US, given to 33 million Americans in the year 2013 alone, frequently for minor infections like those of the sinuses and urinary tract.
I, along with countless others, contacted the FDA, hoping they would hear our plea: Thhese antibiotics are too dangerous to be given as first-line treatment for minor infections (especially when neither doctors nor patients are fully aware of the risks). My neurologist likened Ciprofloxacin being prescribed for my suspected UTI to “killing a fly with an uzi.”
Finally, the FDA has agreed; it announced Thursday that it will require stronger warning labels on Fluoroquinolones so that both doctors and patients can make better, more informed decisions.
Though the FDA’s ruling comes too late for me and for many of my fellow floxies, we are victorious nonetheless; we have been heard. And if our voices successfully prevent even one other person from experiencing the life-altering effects of these drugs, then we will not have suffered in vain.
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May 13, 2016 | STAT Pharmalot, Pharmalitte
By Ed Silverman
Relevant sections pasted below.
The US Food and Drug Administration is requiring boxed warnings about serious and sometimes disabling side effects caused by a class of antibiotics called fluoroquinolones. The side effects can involve damage to tendons, muscles, joints, nerves, and the central nervous system. Most are sold as generics, but well-known brand names include Bayer’s Cipro and Johnson & Johnson’s Levaquin.
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FDA warns about Cipro, other antibacterials Modern Medicine
May 13, 2016 | Modern Medicine
By Christine Blank
FDA issued a new warning about potentially serious side effects associated with fluoroquinolone antibacterial drugs. Affected brands include Cipro, Levaquin, Avelox, Factive and Moxaflaxacin injection, as well as the generic Ofloxacin.
FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options,” FDA said in aMedWatch Safety Alert. “For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.”
FDA’s safety review found that fluoroquinolones, when used systemically (i.e., tablets, capsules, and injectable), are associated with disabling and potentially permanent serious side effects that can occur together. “These side effects can involve the tendons, muscles, joints, nerves and central nervous system,” FDA said.
FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information.
Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course. The symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion and hallucinations.
FDA said it is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program.
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FDA issues major drug warning for popular antibiotic used by millions
May 12, 2016 | ABC 5- NewsNet5
An exclusive 5 On Your Side investigation has contributed to a major drug warning connected to one of the nation's most prescribed antibiotics.
The U.S. Food and Drug Administration advised new restrictions and label warnings for a family of antibiotics known as fluoroquinolones, most commonly prescribed as Cipro and Levaquin.
Last July, our investigation obtained an FDA database that revealed at least 3,000 patients whose death had been linked to the drug and another 200,000 complaints of side effects including kidney infections and nerve damage.
As a result, the FDA now advises restricting the drugs for certain "uncomplicated infections" and is "warning about disabling side effects that can occur."
According to a drug safety bulletin released Thursday, the FDA is advising "serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections."
Health care professionals are being told to "stop systemic" treatment immediately if a patient reports serious side effects.
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FDA: Specific Antibiotic Should Only Be Used As Last Resort
May 12, 2016 | ABC 5- Minneapolis, MN
A popular and powerful antibiotic known to cause severe tendon damage in patients should only be used as a last resort to treat certain types of infections, the Food and Drug Administration (FDA) announced Thursday.
The FDA was asked to review warning labels for fluoroquinolones last year after patients and doctors nationwide expressed concerns about the devastating see effects.
FIVE EYEWITNESS NEWS first reported on the controversial antibiotic, which has been used to treat simple sinus infections but also exposure to anthrax, in 2015 when patients in Minnesota stated they could barely walk after taking their medication.
The FDA announced changes to the warning labels Thursday and stated the “serious side effects associated with fluoroquinolones generally outweigh the benefits” for patients with sinus infections, bronchitis and uncomplicated urinary tract infections.
Fluoroquinolones, like Cipro and Levaquin, should only be prescribed to patients without other treatment options, according to the FDA.
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FDA announces antibiotic label changes following Call 6 report
May 13, 2016 | The Indy Channel- ABC 6
The U.S. Food and Drug Administration has announced labeling changes to antibacterial drugs called fluoroquinolones following multiple Call 6 Investigations into safety issues.
The labeling changes will include an updated boxed warning and medication guide that advises serious side effects with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options.
Patients with those conditions should only use fluoroquinolones as a last resort, according to the FDA.
The announcement comes after years of public testimony and outcry about the drug’s disabling and deadly effects.
“The FDA takes seriously its responsibility to protect the health of the American public through the review of safety, effectiveness and quality of medical products for patients,” according to an FDA statement to Call 6 Investigates. “The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information.”
Indiana mother Heather McCarthy testified before an FDA panel after losing her son Shea, a Purdue University student, in what she believes is a drug-induced death.
"While more work needs to be done the FDA’s changes give weight to the testimony of all those suffering from fluoroquinolone toxicity and sends a clear message to doctors that these drugs must be used sparingly, only when necessary and that physicians must take seriously patient complaints,” said McCarthy in response to the FDA announcement.
McCarthy said the decision also validated her son’s belief that fluoroquinolones had a profound impact on his health.
Shea was prescribed the powerful antibiotic, Levaquin, prior to a nasal surgery.
Levaquin is the brand name for levofloxacin, which is part of a class of drugs called fluoroquinolones, intended to treat major infections like pneumonia, anthrax exposure, plague and urinary tract infections.
“He didn’t even have an infection,” said McCarthy. “This was just to prevent an infection from happening. It’s like taking a cannon to kill a mosquito.”
Heather said her son started acting strangely after taking Levaquin, and told doctors, friends and family he thought the drug was to blame.
Shea quit taking the medication, but the side effects still lingered, according to his mother.
Shea’s anxiety got so bad, he dropped out of school and ended up in the mental health system, where doctors prescribed him more drugs for bipolar disorder.
On Oct. 23, 2013, Shea jumped out of a second story window, got in his car, and crashed into a cement embankment. He died at the age of 24.
“It is now clear that this class of drugs affects multiply bodily systems including the central nervous system and includes neuropsychiatric adverse effects,” said McCarthy on Thursday following the FDA announcement. “I still believe the warnings in this area need to be stronger and under a separate heading so that no one will need to experience the long suffering O’Shea had to bear due to the refusal of his doctors to listen to him. “
McCarthy said she will work to heighten awareness surrounding neuropsychiatric effects of Levaquin and other powerful antibiotics.
A 2014 citizen petition to the U.S. Food and Drug Administration raised concerns about the psychiatric effects of Levaquin including depression, anxiety, and confusion that can start “days, weeks, or months after the last dose.”
The citizen petition requested the FDA add a black box warning on the Levaquin label for “serious psychiatric events,” but the FDA has not yet required that language on the label.
Janssen Pharmaceuticals, maker of Levaquin, released the following statement in response to the FDA label change:
At Janssen, our first priority is the well-being of the people who use our medicines. We are reviewing the Drug Safety Communication and will continue our ongoing collaboration with the FDA to support the safe and appropriate use of fluoroquinolone antibiotics. LEVAQUIN® (levofloxacin) has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening. LEVAQUIN® is part of the important fluoroquinolone class of anti-infective prescription medications, and its safety profile remains well-known and established.
FDA database
Call 6 Investigates obtained the FDA database of adverse reactions to Levaquin and found more than 31,000 complaints since 2010, including 179 reported deaths. Hundreds of patients complained of depression and anxiety, according to the database.
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FDA: Label changes for fluoroquinolones to include warnings of serious side effects
May 12, 2016 | ABC News 8-WRIC
RICHMOND, Va. (WRIC) — On Thursday, the FDA announced that it is now requiring label changes for antibacterial drugs called fluoroquinolones, including an updated boxed warning and Medication Guide, and advising that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options.
For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
Examples of fluoroquinolones include Avelox, Cipro, and Levaquin.
Patients share horror stories from commonly used antibiotics
According to the FDA, a safety review has shown that fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system. As a result, the FDA is requiring label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.
The FDA released the following statement:
The FDA takes seriously its responsibility to protect the health of the American public through the review of safety, effectiveness and quality of medical products for patients. The agency continuously reviews the available sources of data to make a determination about the safety and efficacy of fluoroquinolones and will keep health care providers and the public informed of new information.
Janssen Pharmaceuticals, the manufacturer of Levaquin, also released a statement:
At Janssen, our first priority is the well-being of the people who use our medicines. We are reviewing the Drug Safety Communication and will continue our ongoing collaboration with the FDA to support the safe and appropriate use of fluoroquinolone antibiotics. LEVAQUIN® (levofloxacin) has been used for nearly 20 years to treat bacterial infections, including those that may be serious or life-threatening. LEVAQUIN® is part of the important fluoroquinolone class of anti-infective prescription medications, and its safety profile remains well-known and established.
For more information, please see the FDA’s limited Drug Safety Communication.
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FDA changes warning label on popular antibiotics
May 13, 2016 | WSOC TV
By Alexa Ashwell
Last year Channel 9 investigated patients concerned that popular antibiotics could have having devastating side effects.
Patient Donna Versace spoke to Channel 9 after she learned she won her lawsuit against the Food and Drug Administration.
Now the FDA is requiring label changes for a category of antibiotics known as fluoroquinolones that includes brand names like Ciprofloxacin.
This is after an FDA safety review found the anti-bacterial drugs are associated with "disabling and potentially permanent, serious side effects."
Rachel Brummert has been arguing that for years.
“The FDA acknowledging this is really a big step," Brummert said.
She heads a foundation headquartered in Charlotte that advocates for patients she said suffered permanent side effects from the drugs.
“Two of us from the foundation went up (to Washington, D.C.) to testify with 33 other victims who told their story to the panel,” she said. “They made the right decision.”
The decision to warn patients of side effects associated with those drugs outweigh the benefits for patients with sinus infections, bronchitis and urinary tract infections, officials said.
Other side can impact tendons, muscle joints, nerves and the central nervous system.
Brummert said she's suffered permanent damage to her tendons after taking the medication 10 years ago.
She believes the warnings should go even further.The FDA said in an email these drugs should be reserved for people who don't have alternative treatment options.116
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FDA advises restricting use of fluoroquinolones for certain uncomplicated infections
May 13, 2016 | American Pharmacists' Association
FDA warned Thursday that the serious adverse effects associated with fluoroquinolone antibacterial drugs "generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options." For people with these conditions, the agency said the drugs should be reserved for those with no other treatment options. According to an FDA safety review, systemic use of fluoroquinolones is associated with disabling and potentially permanent serious adverse effects that can occur together. The adverse effects may involve the tendons, muscles, joints, nerves, and central nervous system. FDA said it is requiring the drug labels and medication guides for all fluoroquinolone antibacterial drugs to be updated to reflect the new safety information, and it will continue to investigate safety issues associated with the drugs. -
May 12, 2016 | WEWS (ABC), Cleveland, OH
(Loose transcript) Major drug warning issued tonight, prompted by an exclusive 5 on your side investigation. The Cipro and Levaquin, powerful antibiotics, your investigation has prompted big changes by the FDA.
Listen here: http://app.criticalmention.com/bits/wordplay/#/token=0023c1dd-3964-4d69-9426-d9f6b395647b&channelId=8295&uuid=97a470a3-3a0b-43ea-8f4b-f8c0292cf6e5&keyword=levaquin
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