Invokana increases Amputations – Study

The FDA announced Invokana-197x300May 18, 2016 that Invokana increased the risk of leg and foot amputations in a clinical study. The agency alerted the public that the diabetes medicine canagliflozin (Invokana, Invokamet) increased amputations in the group of people who took it.

The U.S. Food and Drug Administration (FDA) Drug Safety Communication reported that the interim clinical trial results found the increased risk of amputations mostly affected the toes, and said it would investigate.

In the larger picture, the agency said that it had not yet determined “whether canagliflozin increases the risk of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information.”

Canagliflozin vs. Placebo

The ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial’s independent data monitoring committee (IDMC) identified the increased risk of leg and foot amputations. They occurred roughly twice as often in patients treated with canagliflozin compared to others treated with placebo. Interim analysis over a year’s time showed the risks of amputation for patients in the trial were equivalent to:

•  7 out of every 1,000 patients treated with 100 mg daily of canagliflozin
•  5 out of every 1,000 patients treated with 300 mg daily of canagliflozin
•  3 out of every 1,000 patients treated with placebo

CANVAS trial patients have been followed an average of 4 ½ years up to May 2016. But despite the apparent increase in amputations, the IDMC (Independent Data Monitoring Committee – apparently none of whom is personally part of the trial) recommended that the CANVAS trial continue.

The IDMC also said that a second trial evaluating canagliflozin – the CANVAS-R trial – has thus far not shown the same risks of increased leg and foot amputations. Patients in this second trial have been followed an average of nine (9) months.

Meanwhile, the FDA urges health care professionals and patients to report “side effects” involving canagliflozin or other medicines to the FDA MedWatch program.

FDA: Consult your Doctor

FDA further said that patients should not stop or change diabetes medicine without first speaking with their health care professional. Stopping diabetes medication can lead to uncontrolled blood sugar levels which can cause serious problems that include blindness, nerve damage, kidney damage, heart disease. Patients taking canaglifozin should consult their doctor if they feel any new pain, tenderness, sores, ulcers, or infections in the legs or feet.

Cangliflozin / Invokamet / Invokamet

Canagliflozin is a prescription medicine designed to help lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to excrete sugar from the body through the urine. The drug is available as a single-ingredient product under the brand name Invokana. It is also available in combination with the diabetes medicine metformin, under the brand name Invokamet.

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Heartburn Drugs double risk of Kidney Problems

Common heartburn Nexiummedications known as proton pump inhibitors (PPIs) increase the risk of new and severe kidney disease, according to a United States study.

Hundreds of thousands of new users of PPIs (without kidney disease) examined in the Department of Veterans Affairs (VA) were found to be 30 percent more likely to develop chronic kidney disease over the course of five years of using PPIs. Risk of kidney failure doubled for these patients.

Nexium, Prevacid, Prilosec, Protonix, Aciphex

PPIs like Nexium and Protonix are prescribed to treat ulcers, so-called “heartburn,”  and acid reflux. Authors of the study, published in the Journal of the American Society of Nephrology, said that these drugs are generally considered safe, but noted they may be overprescribed and continued for longer periods than necessary.

PPI Drugs vs. H2 Blockers

Senior author Dr. Ziyad Al-Aly, associate chief of staff for research and education at the VA Saint Louis Health Care System, said, “We suggest judicious use of PPI, and that use be limited to when it is medically necessary and to the shortest duration possible.”

Study authors analyzed data in national VA databases covering 20,270 new users of PPIs. They compared these people to 173,321 others who had begun H2 blockers, which reduce stomach acid by a different mechanism; H2s block histamines in the stomach.

No patients had kidney problems at the start. They were followed for five years to monitor their kidney function.

After adjusting for personal, social, economic factors and health conditions that could impact kidney disease risk, the study found PPI users at significantly higher risk of new kidney problems compared to H2 blocker users.

People taking PPIs faced a risk of a decline in kidney function 32 percent higher, while the risk of new cases of chronic kidney disease was 28 percent higher.

PPIs and Renal Disease

People taking PPIs were 96 percent more likely to experience end-stage renal disease – kidney failure – than those who took H2 blockers. The risks also increased over time with PPIs, stabilizing after some two years.

PPI Problems and OTC Use

Dr. Al-Aly said that because many PPIs are available over the counter (OTC), people may take them without doctor guidance. He recommends limiting the use of OTC PPIs. He told Reuters Health that he recommends that people who frequently take OTC PPIs consult their doctors to determine the best and safest options.

H2 Blockers less likely to cause kidney problems

Dr. David Juurlink, a clinical pharmacologist and drug safety researcher at the University of Toronto, told Reuters by email that H2 blockers are much less likely to cause kidney problems but are often not as effective as PPIs.

Dr. Juurlink said, “For many patients, dietary modification (less fat and alcohol) would make acid-lowering drugs unnecessary and would impart other long-term benefits as well.”

Heartburn drugs double risk of kidney problems

Dr. Juurlink also pointed out that PPIs carry risks like all drugs, and that just because a drug is available OTC doesn’t mean it’s safe. He advised that PPI users who develop kidney problems ask their doctors whether the drugs might be a factor.

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Talcum Powder Ovarian Cancer Link

Three juries have Talcum Powder Ovarian Cancerheard evidence of a talcum powder ovarian cancer link. Three juries have heard counter arguments from Johnson & Johnson defense attorneys that no such link exists. Three juries have concluded that such a link does exist. All three juries have also ruled Johnson & Johnson failed to warn women that talc can cause ovarian cancer.

Defense attorneys, meanwhile, continue to argue in the media and on appeal that there is no link, that J&J talcum powder products are safe for women to apply to their genital areas or anywhere else. Defense claims studies show talcum powder is entirely safe.

Scientific Evidence for Talc Cancer Link

What is the scientific evidence for a talc ovarian cancer link?

A professor of obstetrics, gynecology and reproductive biology at Harvard Medical School and director of the OB/GYN Epidemiology Center at Brigham and Women’s Hospital in Boston conducted one of the earliest studies linking genital talc use in women and ovarian cancer. His name was Dr. Daniel Cramer and his research was published in 1982. In Dr. Cramer’s opinion, strong evidence from some two-dozen epidemiological studies shows a significant association between talc use for feminine hygiene and ovarian cancer. Dr. Cramer told Live Science that these studies have found regular talc use may increase overall risk of ovarian cancer by about 30 percent. (LiveScience.com: Does Talcum Powder cause Ovarian Cancer?)

A study published in June 2016 showed talc powder applied not only to the genitals but anywhere on the body may raise the risk of cancer. The study also showed that black women – who were specifically target by J&J for talc sales – are at greater risk of ovarian cancer if they use talc.

 

Talc may cause ovarian cancer if regularly applied to genitals, sanitary napkins

Researchers with Brigham and Women’s Hospital in Boston said talcum powder has been linked to ovarian cancer when applied to genitals. To determine whether genital talc is a potential carcinogen (capable of causing cancer), researchers recruited 2,041 women with ovarian cancer and 2,100 without the illness, and asked them about their talcum powder use. Researchers found that applying the product to genitals, underwear, and sanitary napkins increased the risk of developing ovarian cancer risk by one third.

Talcum Powder Ovarian Cancer Link

The question then becomes whether these percentages are statistically significant enough to prove approximate causation, general causation and specific causation. The legal bars for each will continue to be haggled over in more talcum powder ovarian cancer trials to come.

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Iowa Cancer Rate Glyphosate

Iowa leads all states GlyphosateCancerand most countries in corn growing, 93% of which is genetically modified (GMO) corn grown with increasingly greater amounts of Monsanto’s Roundup glyphosate and other herbicides. Iowa is also the Midwestern state with the highest incidence of cancer. Is there any link between Iowa’s amazing corn growing capacity and cancer, or is Iowa’s cancer rate only coincidental?

According to the Centers for Disease Control (CDC), Iowa has the highest rates of cancer of any state in the Midwest. Consequently, or coincidentally, depending on your viewpoint, it should come as no surprise, or perhaps it’s only a matter of passing concern (and there is no causal link) that 97% of soybeans and 93% of corn grown in Iowa are genetically engineered and sprayed with massive amounts of pesticides and herbicides. These poisons sprayed on growing food fed to animals and humans include Monsanto’s Roundup, the main ingredient – glyphosate – of which the World Health Organization’s International Agency for Research on Cancer (IARC) has linked to causing cancer in humans.

Iowa GMO Corn King

Iowa doesn’t brag about its cancer rate, but it does brag about its corn production.

Iowacorn.org reports that in 2015 Iowa corn farmers grew 2.5 billion bushels of corn on 13 million acres of land. At 56 pounds per bushel, that’s more than 140 billion pounds of field corn. (Source: USDA March, 2016)

Iowa has been the king of corn for nearly two decades. The state produces more corn than any other, and more corn than most countries. Iowa grows about three times more corn than the entire country of Mexico.

Iowa’s GMO Corn Problem

Corn has been the top crop in Iowa for more than 150 years, but it wasn’t until GMO corn from Monsanto and other biotech companies took over the corn market that the state began to lead all others for cancer rates.  Iowacorn.org says that state farmers don’t lack imagination for growing things; it’s just that, for several reasons, Iowa is the best place on earth to grow corn.

Corn grows well in Iowa because the state has a long and warm enough growing season for corn; enough rain for corn; deep, rich soils that suit corn growth; lots of homegrown livestock with waste that includes nutrients key to fertilizing corn fields; a wide variety of corn hybrids that do well in Iowa’s environment.

Iowacorn.org, an obvious promotional web site, makes no mention of the fact that 93% of Iowa corn is genetically modified – GMO – corn. That major oversight shows clearly that site tenders know that announcing your GMO percentages is not a good selling point.

Though Iowa has long been a leader in corn production, it has not always been a leader in cancer rates. It’s taking over the Midwestern state’s lead in cancer per capita can be shown to be in direct correlation to the introduction of GMO corn and soybeans. GMO pushers can dispute the parallels as mere coincidence, but people who live in Iowa and have seen local cancer rates skyrocket since the proliferation of GMO corn and soy might beg to differ. (GMO corn pushers are banking on the idea that most cancered people’s stories can be written off as merely “anecdotal.”)

American Farmers’ Cancer Trends

Meanwhile, from 1993-1997, before GMO corn and soy became the new “normal,” the National Cancer Institute recruited some 90,000 participants for a cancer study. Most of the participants in the ongoing study are either farmers or their wives; 52,000 farmers and 32,000 farmers’ wives. All were recruited in Iowa or North Carolina.

Participants classified as “private pesticide applicators” are farmers or nursery workers. The study also includes a small percentage of “commercial pesticide applicators” from Iowa who work for pest control companies or for businesses (such as warehouses or grain mills) that use pesticides regularly. Some 5,000 participants are commercial applicators.

Cancer Trends lower among Farmers

The National Cancer Institute notes that farmers in many countries, including the U.S., have lower overall death rates and cancer rates than the general population. The lower death rates among farmers for heart disease, cancers of the lung, esophagus, bladder, and colon, in particular, are thought to be at least partly due to lower smoking rates, though farmers are typically also physically active and are thought to consume healthy foods compared with most people.

Leukemia, non-Hodgkin’s Lymphoma, Multiple Melanoma Higher among Farm Workers

When compared with the general population, however, rates for certain diseases that include some cancers appear to be higher among agricultural workers and farmers, according to the National Cancer Institute. That increase may be related to exposures common in farm work environments.

Monsanto Lawsuits

Farming communities, acording to the National Cancer Institute, experience higher rates of leukemia, non-Hodgkin lymphoma, multiple myeloma, and soft tissue sarcoma, as well as cancers of the skin, lip, stomach, brain, and prostate. Farm workers with some of these types of cancers are beginning to file Monsanto Lawsuits because glyphosate has been linked with some of these cancers.

The National Cancer Institute, meanwhile, claims that no one set of risk factors explains these higher cancer rates, though it does admit, “[T]he range of environmental exposures in the farming community is of concern. Farmers, farm workers, and farm family members may be exposed to substances such as pesticides, engine exhausts, solvents, dusts, animal viruses, fertilizers, fuels, and specific microbes that may account for these elevated cancer rates.”

Research studies reported to date have not allowed researchers to sort through which factors may be linked to which cancer types, at least according to the National Cancer Institute, though that organization is increasingly funded by industry.

Other studies, however, have found a glyphosate cancer link, as well as a glyphosate link to kidney and liver damage.

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Risperdal Trial in Texas

Texas’ 58th Judicial risperdalDistrict Court in Beaumont will host a Risperdal trial this month. Beginning June 12, 2016, Jacoby Moore vs. Ortho-McNeil-Janssen Pharmaceuticals, Inc., et al. will be presented to the first Texas judge and jury to hear a Risperdal claim.

Trial Update: A continuance has been granted; this trial will now begin Sept. 12, 2016.

Gynecomastia Injury alleged

Mr. Moore, represented by Houston law firm Matthews & Associates, is suing J&J’s Ortho-McNeil and Janssen for the case of gynecomastia he says he developed as a minor. Gynecomastia is a painful condition in which males develop female breast tissue. The petition alleges that the J&J companies illegally marketed the drug to Mr. Moore’s doctor for off-label use in minors despite knowing that the drug raised the risk of gynecomastia.

Risperdal Background

Risperdal is a powerful atypical antipsychotic developed by Janssen-Cilag, a subsidiary of Johnson & Johnson. It was approved by FDA in 1993 for the treatment of schizophrenia in adults.

Released in 1994, Risperdal became one of the most profitable drugs in history, bringing billions of dollars in profits.

In 2003, FDA approved risperidone, the chemical name for Risperdal, for the short-term treatment of the mixed and manic states associated with bipolar disorder in adults.

“But,” the petition reads, “many executives, marketing professionals, and even sales representatives were more interested in its unapproved use in children.”

Although the FDA never approved Risperdal for use in children and adults, in 2003 unapproved prescriptions accounted for most Risperdal sales.

J&J failed to Warn

The petition reads: “Johnson & Johnson and Janssen by and through its agents, servants, directors, officer(s) and employees knew, or should have known, about the devastating side effects that Risperdal could bring to children, but they failed to inform or to adequately inform physicians, including the Physician Defendant about this vital information.”

Jacoby Moore was a 7-year-old boy living in Beaumont in 2003 when he was prescribed Risperdal for Attention Deficit Hyperactiity Disorder (ADHD) and behavioral problems. Though Risperdal was not approved for use in children, Mr. Moore was prescribed it by his doctor, who had been encouraged by J&J to subscribe the drug to children.

The petition reads: “But for the Manufacturer Defendants’ off-label marketing, recommending, advertising, and promoting, the Physician Defendant would not have prescribed Risperdal to Plaintiff for off-label use. The Physician Defendant prescribed Risperdal to Plaintiff Jacoby Moore as it was recommended, promoted, and advertised to him by the Janssen Defendants.”

Risperdal Trial in Texas

The trial, the third to try J&J for Risperdal in civil court, is expected to last three weeks.

In the first Risperdal trial in February 2015, a jury hit J&J’s Janssen with a $2.5 million verdict. In the second Risperdal trial, in March 2015, a Philadelphia jury found Janssen had failed to warn that Risperdal could cause male breast growth, but awarded no damages to a young man for whom the jury found no direct link to his condition.

J&J, Janssen fined $2.2 Billion +

In 2013, Johnson & Johnson and Janssen paid more than $2.2 billion to resolve civil and criminal investigations by the U.S. Department of Justice into the marketing of Risperdal and several other drugs.

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IVC Filter Problems Unreported

IVC filter IVC Filterproblems, whether made by Bard, Cook Medical, Boston Scientific, Greenfield or some other medical device maker, all share at least one thing: their actual numbers of adverse events are vastly under-reported.

According to a 2000 report published by the U.S. General Accounting Office, “Experts believe that FDA’s system includes an estimated 1 to 10% of adverse reactions.” That means that for every ten events that get reported, 90 adverse events go unreported.

IVC Filter Problems Unreported

Most MAUDE reports are filed by device manufacturers, which typically presents a problem because in many (if not most) cases the device makers never hear of the adverse event. Meanwhile, it takes a doctor at least 20 minutes to file a MAUDE report, according to most doctors we have asked; therefore, very few ever take the time to file such a report. Doctors simply do not have or cannot take the time, and even if they did have the time, filing adverse event reports could find them dragged into a lawsuit regarding a faulty or troublesome device, another time-consuming proposition that most doctors would rather avoid. So there is very little incentive and perhaps worse than no reward to prompt a doctor to file an adverse event report.

Meanwhile, we the public are unfortunately stuck with MAUDE as our only publicly accessible medical device source.  We say “publicly accessible” in very broad sloppy fashion, because even though you can navigate to the FDA’s MAUDE pages and even the IVC Filter section of it, you will be hard pressed to determine even the 10% of actual adverse events that have been reported concerning, Bard, Cook, Boston Scientific, Greenfield, or any other IVC filter.

MAUDE Overview

The MAUDE – a messy acronym for Manufacturer And User Facility Device Experience – is the U.S. FDA’s web page (FDA: MAUDE Data) set up to record adverse events of medical devices. It is at least supposed to contain that 10% of the total adverse events which it was estimated by the 2000 study to record; but trying to locate even that lowly 10% portion of adverse events reported can prove a daunting task on the site.

For IVC Filters, the MAUDE database includes a May 6, 2014 update on an earlier IVC Filter Warning:

Summary of Problem and Scope

“The FDA has received reports of adverse events and product problems associated with IVC filters. Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”

Temporary IVC Filters not Removed

We will take up the topic of the late removal or the failure to remove what were supposed to be temporary IVC filters in our next IVC Filter post. Many so-called “temporary IVC filters” are left in indefinitely to the great detriment of their unwitting implantees, as many are trauma patients who never had a say in the matter.

To be continued. . .

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Invokana linked to Amputations

Patients in a Invokana Lawsuitclinical trial taking Invokana and Invokamet were roughly twice as likely to suffer amputations as patients taking placebo. The U.S. FDA reported the clinical trial results May 18, 2016 on Janssen Pharmaceuticals’s top-selling diabetes’ drugs.

FDA said the trial revealed that the equivalent of five of every 1,000 patients taking a 300-milligram daily dose of the active ingredient canagliflozin needed amputations, while an equivalent seven of every 1,000 patients taking a 100-milligram daily dose needed amputations. Meanwhile, on the placebo side of the trial, just three of every 1,000 patients taking the “drug” required amputations.

Invokana linked to Amputations

The amputations in the trial concerned toes, feet, and/or legs. FDA officials said they are working to determine whether canagliflozin really does elevate the risk of amputation. FDA cautioned that patients shouldn’t stop taking Invokana or Invokamet without first seeing their doctor.

FDA said, “Patients taking [canagliflozin] should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”

Canagliflozin is the only active ingredient in Invokana. In Invokamet, canagliflozin is combined with metformin, another active ingredient.

Invokana, Invokamet for Type 2 Diabetes

Invokana and Invokamet, approved in 2013 and 2014, are used to control blood sugar levels in Type 2 diabetes’patients.

The ongoing trial examines how canagliflozin affects cardiovascular health. It has followed patients for 4 ½ years so far. FDA said that a similar clinical trial that has followed patients for nine months has not found the same elevated risks of amputation.

Janssen Responds

Janssen officials said in a statement that they, “remain confident that canagliflozin is an important treatment option for people with Type 2 diabetes.”

Company officials also claimed that the increase in amputations has not been observed in a dozen other Phase III and Phase IV trials or in postmarketing safety reports.

According to the Mayo Clinic, diabetics are already at risk of amputations because the disease can cause nerve damage and impair blood circulation.

Invokana Warnings

Invokana was the first in a class of drugs known as sodium-glucose cotransporter 2, or SGLT2 inhibitors. The drug was approved despite concerns regarding cardiovascular health and bone safety. Since approving Invokana, the FDA has since updated Invokana’s and Invokamet’s warning labels to reflect bone fracture risks. Invokana’s labels, along with the labels of other SGLT2 inhibitors, have also been updated to disclose blood disorder risks and urinary tract infections.

SGLT2 Inhibitors

Other drugs in the SGLT2 class include AstraZeneca PLC’s Farxiga and Xigduo XR, (dapagliflozin, and a dapagliflozin-metformin combination); Boehringer Ingelheim GmbH; and Eli Lilly and Co.’s Jardiance and Glyxambi (empagliflozin and an empagliflozin-linagliptin combination).

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Monsanto Stock falls with Cancer Finding

Monsanto’s stock imagesprices fell when the World Health Organization found that Monsanto’s Roundup is “probably carcinogenic” for human beings. It is difficult to overstate the potential of that pronouncement’s being bad news for Monsanto. Roundup and its main ingredient, glyphosate, represent the cornerstone of the biotech bully’s entire ag-chemical business model.

Monsanto Stock falls with Cancer Finding – WSJ

Monsanto Makeover Aborted

Prior to glyphosate’s being declared a probable carcinogen for humans, Monsanto had for years been trying to rehabilitate its image from that of a chemical producer that makes things to kill plants – Agent Orange, for example – into a beneficent agricultural corporation interested in making drought-resistant seeds that bring higher crop yields.

California acts to ban Glyphosate

Other people interested in the quality of the food they eat – such as those in the state of California – looked at the WHO’s proclamation that glyphosate was carcinogenic. California examined the evidence for its citizens and the rest of the world – a huge portion of whom eat California fruits, vegetables and other glyphosate-tainted food, including California wine (also contaminated with glyphosate) – and the state then moved to ban the toxic substance.

Monsanto sues California

As is so often the case when someone moves to ban the great and powerful Monsanto, the company quickly acted to sue California for having the temerity to think it could keep the chemical giant from dumping carcinogenic toxins into the state’s food and water supplies.

Monsanto is suing California in an attempt to block it from adding Roundup to the Proposition 65 list of chemicals known to cause cancer, birth defects, and other reproductive damage. California had been planning to add glyphosate to its Prop. 65 list since September 2014, after the WHO declared glyphosate a probable human carcinogen. Prop. 65, you see, requires the state to label all substances identified as carcinogenic or dangerous to the reproductive process. Nevertheless, Monsanto argues in its lawsuit filed in Fresno County that glyphosate is not harmful. What other argument could the monster make?  This is the fight of its life, and one that should have taken place before glyphosate was ever unleashed on the public.

 

EPA balks on Glyphosate Ruling

The U.S. EPA, meanwhile, also said it would take another look at glyphosate. EPA declared it a carcinogen in 1985, then later inexplicably reversed that decision in a very curious maneuver; at least two of its top researchers on the project refused to sign their names to the green light change. Then in 2016, the EPA balked on glyphosate again, first declaring the chemical not carcinogenic to humans, then pulling that review and claiming it had only inadvertently published it.

 

Glyphosate spawns Superweeds

Glyphosate use has increased dramatically in recent years. Originally used primarily on cotton, soybeans and corn, it is now sprayed indiscriminately (wafting for miles over fences all over the world) on many more popular crops people eat every day, including wheat. If California were to add gyphosate to its carcinogen list as it plans to do, many of those foods might have to carry the familiar Prop. 65 warning label. That could drastically cut into Monsanto profits, unless perhaps people develop a taste for glyphosate like many have for cigarettes, despite their warning labels.

Although the warning labels are legally required only in California, most manufacturers include them on the labels of products sold elsewhere because of the cost and complexity of having separate labels for different states.

Pesticides wiping out Bees

On top of Monsanto’s Roundup/glyphosate cancer problem is another little problem, one that is wiping out our pollinators, without which Albert Einstein and others have observed we cannot survive. It is during corn planting season when Roundup use is at its highest levels that our honeybees are being killed off in catastrophic numbers. According to the USDA, beekeepers lost 44 percent of their honey bee colonies in 2015.

Thom Hartmann at TruthOut writes, “This loss is considered too high to be sustainable for US agriculture and the beekeeping industry.”  (You think, Thom?)

Tiffany Finck-Haynes, a food futures campaigner with Friends of the Earth, said, “These honey bee losses reinforce what sciences continues to tell us; we must take immediate action to restrict pesticides contributing to bee declines. The longer we wait, the worse the situation becomes. If we do not suspend neonicotinoid pesticides immediately, we risk losing our beekeepers and harming important ecosystem functions upon which our food supply depends.”

 

A Monsanto Future

Orwell said, “If you want a picture of the future, imagine a boot stamping on a human face – forever.” The ever-encroaching police state would seem to make that remark prescient, but for a future determined by the biotech bully of St. Louis, we can imagine Monsanto executives living in underground bunkers with Dick Cheney and others of their corporate ilk forking dollar bills into their mealy mouths, then chasing their green meal with glyphosate.

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FDA orders Stronger Warning Labels for Antibiotics

On May 12, 2016, Ciprothe U.S. Food and Drug Administration advised against the use of a class of antibiotics known as fluoroquinolones for the treatment of certain infections in patients with other treatment options.

FDA said the serious side effects associated with fluoroquinolones outweigh the benefits for patients with alternative treatment options. These “side effects” (a euphemism for “actual effects”) include disabling, potentially permanent damage to tendons, muscles, joints, nerves and the central nervous system. The agency is requiring that updated drug labels and medication guides reflect the new safety information.

Avelox, Levaquin, Cipro, Others

Brand-name fluoroquinolones include Avelox, marketed by Merck & Co. Inc.; Levaquin, marketed by Johnson & Johnson; Cipro, marketed by Bayer; and a few others.

 FDA-approved Fluoroquinolone Antibacterial Drugs

Brand Name Active Ingredient                         Maker
Avelox Moxifloxacin                                                     Merck
Cipro Ciprofloxacin                                                    Bayer
Cipro extended-release Ciprofloxacin extended-release          Bayer
Factive Gemifloxacin                                                 GeneSoft
Levaquin Levofloxacin                                     Johnson & Johnson
Moxifloxacin Injection Moxifloxacin                                        Bayer
Ofloxacin Ofloxacin                                          Ortho-McNeil-Janssen

The FDA announcement comes after an advisory committee ruled in November 2015 that fluoroquinolones lack adequate safety warnings. Law 360 reported that the committee determined in several unanimous and near-unanimous votes that the antibiotics’ labels gave inadequate 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.

Fluoroquinolone Patients cautioned

Patients taking fluoroquinolone medications and experiencing any serious side effects, including tendon, joint and muscle pain, “pins and needles” tingling sensation, confusion, hallucinations, should notify their doctors immediately. Health care professionals, meanwhile, should stop using the drug if a patient reports such symptoms. FDA said the patient should be switched to a non-fluoroquinolone drug.

FDA orders Stronger Warning Labels for Antibiotics

The FDA said that it’s continuing to investigate safety issues related to fluoroquinolones and will update the public if additional information becomes available.

Antibiotic Lawsuits

The antibiotic class  of fluoroquinolones has been the subject of several lawsuits.

Earlier in 2016, Pennsylvania state Judge Jacqueline F. Allen denied plaintiffs’ attempts 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 antibiotic drugmakers hid the risk of permanent nerve damage resulting from fluoroquinolones.

Levaquin Lawsuit

In January 2016, U.S. District Judge Manish S. Shah, in Illinois, denied Johnson & Johnson’s bid to dismiss a lawsuit brought by a man who blames Levaquin for several serious physical injuries. That plaintiff accuses Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. of failing to adequately test the drug, make it safely, or warn people of its risks.

The plaintiff said he took Levaquin for just five days in October 2010 to treat an infection. Between then and early 2011, he began to experience many physical problems, he said, including tendon and joint issues, neurological, and gastrointestinal problems.

Antibiotic Nerve Damage Linked in 1992

Law 360 reports that a “Belgian doctor first established a link between fluoroquinolone drugs and permanent nerve damage in 1992.”  The FDA told Bayer in 2002 that several reports suggested such a relationship.

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Talcum Powder Cancer $72 Million Verdict

A talcum powder cancer baby-powder-lawsuit1lawsuit rendered a $72 million verdict in St. Louis jury on Feb. 25, 2016. The jury greed that a woman died of ovarian cancer from her long-term use of Johnson & Johnson talcum powder. The state court jury ordered J&J to pay the woman’s surviving family $10 million in compensatory damages and $62 million in punitive damages. The latter are awarded by juries when they want to punish a defendant for wrongful conduct. Bloomberg News reported that the woman died in 2015 after many years of using Johnson & Johnson baby powder and another talc-based product. Several other Talcum Powder Cancer Lawsuits are pending.

The case is number 1422-CC09012-01, 22nd Judicial District (St. Louis), Missouri.

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