Secure your Shingles Vaccine Records

Waiting for a Rx Recordslaw firm to order records of your shingles vaccination in a potential shingles vaccine lawsuit could fatefully harm your potential case. By law, pharmacies, hospitals and other medical records entities are required to produce records within one month of receiving a request; however, long experience has taught us that this virtually never happens. Therefore, it is best to secure your shingles vaccine records if you can, or the records of any other vaccine or prescription drug you ever take.

Waiting for Pharmacy Records

A wait of three months or longer is often the norm after we order pharmacy records. Even a nine-month wait for records is not entirely unusual. That long wait can spoil a case. The necessary records may have been purged by the pharmacy or hospital administration in the interim. If and when that happens, the potential case could be lost before it ever starts.

Records Purging at Record Pace

Drug stores and pharmacies such as Walgreens, CVS, Wal-Mart and others are purging their records faster every year. Many previously kept their customers’ pharmacy records for 10 years or longer. Not any more. Many now purge their records in as little as five or six years, some now in as short a span as three years.

Protect your Pharmacy, Medical Records

To protect your own interests and to help make or expedite your potential shingles vaccine lawsuit – or any drug case lawsuit – it would be wise to secure your pharmacy records right now, today. In the future, it would also be wise to get and keep a copy of every prescription you’ve ever filled. Ideally, you don’t want to be in a position of waiting for a law firm to secure your records.

Matthews & Associates Orders Records

At Matthews & Associates, we order pharmacy and medical records for virtually every client we sign; nevertheless, given the vicissitudes of nearly always being forced to wait several months for records to appear, we advise all of our clients who we think have a case to get their records themselves as soon as possible.

Free Consultation

Matthwes & Associates offers a free legal consultation for anyone who was diagnosed with shingles after receiving the shingles vaccination, and anyone who suffered eye injury as a result of the shingles vaccination.

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Shingles Vaccine Eye Damage

The shinglesZostovax vaccine Merck Pharmaceuticals has been marketing since 2006 now comes with a warning that it could cause eye damage. February 17, 2016, the FDA approved a label change to Merck’s Zostamax vaccine prescribing information. The change to the label added “Eye Disorders: necrotizing retinitis.” Merck consequently faces Shingles Vaccine Lawsuits over this dubious vaccine.

Keratitis Vision Damage from Vaccines

WebMD reported that researchers found 20 cases of keratitis in children and adults that occurred within a month of receiving a chickenpox or shingles vaccine. Keratitis symptoms for adults developed within 24 days of vaccination, while symptoms in children began within 14 days of vaccination. Researchers concluded there is a probable relationship between the vaccine and the eye inflammation, though the study wasn’t designed to prove the vaccine actually caused the condition. (Of course it wasn’t.)

Keratitis causes inflammation and scarring of the eye tissue. If one fails to get treated fast, it can lead to permanent vision loss.

Health Sciences Institute (HSI) points out in a Jan 21, 2016 piece that the researchers say they don’t know why the shingles shot may cause keratitis, but we do know that keratitis has been linked to autoimmune disorders, and that shots like the shingles vaccine can profoundly short circuit the immune system.

The mainstream media didn’t miss a beat, of course, telling us that despite these little “side effects” (hardly worth a mention, really), it’s still a good idea to get the shingles vaccine, and never mind the fact that it barely works at all, or perhaps causes more cases of shingles than it prevents.

Shingles Vaccine causes Shingles

The mainstream failszostovax to tell us that the shingles vaccine causes shingles. Funny they leave that out, because even the FDA is aware now that the shingles vaccine features an absurd problem.  In August 2014, FDA approved a change to the shingles vaccine warnings label to include that the shingles vaccine causes – wait for it – shingles!  Yes, you read that right.

Shingles Vaccine Fails to Work as Advertised

HSI further points out that “UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up. And if you’re over 70, you’d be lucky to get those odds.”

So these people from WebMD and other mainstream media outlets who take endless money in advertising from Big Pharma and never see a drug or vaccine campaign they don’t like, are now telling you it’s worth risking eye damage, maybe up to blindness, to take a shingles shot that fails more than 99 percent of the time, and uh, just happens to also give you shingles? That’s a chance worth taking? You take it, friend. We shall pass on the shingles vaccine.

More Shingles Vaccine “Side Effects”

The Zostovax label lists the most common side effects as “headache, redness, pain, itching, swelling, hard lump, warmth, or bruising where the shot was given.”  Other “side effects” include:

• allergic reactions, which may be serious and may include difficulty in breathing or swallowing. (breathing is kind of important, so you may want to read this one.)
•  chickenpox
•  fever
•  hives at the injection site
•  joint pain
•  muscle pain
•  nausea
•  rash
•  rash at the injection site
•  shingles
•  swollen glands near the injection site (that may last a few days to a few weeks)

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Cook must produce IVC Filter FDA Reports

Virtually every IVC Filterlawsuit involves a judge’s issuing key rulings that impact the outcome. A judge’s decisions for the court can hinder plaintiffs  – such as the recent judge in the Mirena birth control cases who ruled to exclude all the plaintiffs’ experts, which challenges the hopes of women who have alleged Mirena injury. On the other hand, a judge’s rulings can also help plaintiffs.  A recent judge’s ruling in the Cook IVC filter multidistrict litigation has allowed plaintiffs to continue building their cases.

“Discovery” Allowed in Cook’s Reports to FDA

In May 2016 in the Cook IVC filter multidistrict litigation set in Indiana, a federal judge refused to bar Discovery involving plaintiffs’ allegations that Cook failed to file reports to the FDA that showed bad results with some Cook IVC filters.

Adverse Device Events allowed in IVC Filter Cases

Plaintiffs in the Cook IVC filter cases requested Discovery relating to information Cook Medical delivered to the FDA regarding the outcomes of patients implanted with Cook IVC filters. The plaintiffs’ group believes Cook underreported IVC filter device problems to the FDA. The group wants access (Discovery) to all information regarding whatever Cook shared or possibly failed to share with FDA.

Cook Medical requests Protective Order to Conceal Reports

Cook Medical responded by filing a motion for “protective order,” which would have effectively barred Discovery of reports Cook made to FDA. Cook argued that it had no duty to produce this information to the plaintiffs, based on some recent court decisions.

Cook IVC Filter MDL Magistrate Judge Tim Baker disagreed with Cook’s attorneys. Judge Baker ruled that this information requested by plaintiffs is potentially relevant to the claims in the case. He ruled that Cook has an obligation under the Rules of Civil Procedure to produce this information. Since Judge Baker denied Cook’s motion, the company is now required to produce this FDA reporting information to attorney David Matthews and other lawyers representing plaintiffs in the MDL.

Discovery

Once a lawsuit is filed, defendants have a chance to “answer” or enter a plea to the complaint, either by admitting the complaint is true or by denying its veracity. Following the filing of these “pleadings,” the battling parties engage in formal discovery. Discovery in civil litigation is the exchange of documents and information between the parties. The Rules of Civil Procedure require Discovery. This occurs when one side writes questions (Interrogatories) or requests for documents (Requests for Production of Documents). Unless there is a compelling reason to withhold the information, the other side must then prepare written answers and make all requested documents available to the requesting party. The parties then use that information to build their cases for trial.

Discovery Decision Impacts IVC Filter Cases

The court’s decision allows the plaintiffs to “discover” information Cook sent to FDA regarding Cook IVC filters and adverse events. Plaintiffs’ cases may be aided if those Cook reports to FDA are false, misleading or incomplete. Plaintiffs’ petitions now charge that Cook misrepresented IVC filter efficacy and safety, and that Cook failed to adequately warn of the risks.

IVC Filter Problems Underreported?

If it turns out that Cook underreported problems with the Cook IVC filter, the defense of the learned intermediary doctrine could be stripped from the case. The learned intermediary doctrine means that a medical device manufacturer cannot be liable for negligence if it provides all necessary information to a “learned intermediary” such as the doctor or implanting surgeon. It is that learned intermediary’s responsibility to inform the patient of the risk-benefit analysis, the benefits and risks of using the medical device. Medical device makers typically argue to the court that they notified the doctor (and therefore the patient) about the risks involved; it is the doctor’s responsibility to explain those risks to the patient.

However, if the IVC filter (or other device) maker underreported problems to the FDA, the learned intermediary doctrine becomes meaningless. The physician could not have informed the patient of the real risk-benefit profile if only limited information were available, especially if that information were withheld. Consequently, if Cook Medical can be shown to have underreported or misreported IVC filter problems to FDA, its defense could be substantially weakened.

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FDA Reporting Regulations:

Medical device makers must report to FDA (1) within 30 calendar days of learning information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance or service to prevent a public health problem.

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Invokana Warnings FDA Strengthened

Invokana warnings Invokana-197x300were strengthened by FDA June 14, 2016. The announcement topped the existing FDA warning made May 18, 2016. The agency wrote that recent reports prompted it to revise the warnings on Invokana’s label to include information about acute kidney injury. FDA also said that it added recommendations to minimize the risk of acute kidney injury from the type 2 diabetes medicines. In addition to Invokana, drugs included in the warning include Invokamet and Dapagliflozin (Farxiga, Xigduo XR).

Type 2 Diabetes Medications

Canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) are prescription medicines used to help lower blood sugar in adults with type 2 diabetes. These drugs belong to a class called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing kidneys to remove sugar through the urine.

FDA said in the June 2016 announcement that from canagliflozin’s approval in March 2013 through October 2015, it had received 101 confirmable case reports of acute kidney injury. Some required hospitalization and dialysis, with canagliflozin or dapagliflozin use. That number includes only reports submitted to FDA; the agency says there are likely additional cases not reported. (In point of fact, it is generally known that only some 10 percent of adverse drug reactions are reported to the FDA.)

Invokana Warnings FDA Strengthened

The FDA recommended that health care professionals consider factors that may predispose people to acute kidney injury before starting those people on canagliflozin or dapagliflozin. The agency said factors that may predispose people to kidney injury include “decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs).” The agency recommends assessing kidney function before beginning canagliflozin or dapagliflozin, and monitoring the patient periodically thereafter. FDA also said, “If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”
Acute Kidney Injury

Acute kidney injury occurs when the kidneys quit working, which causes dangerous wastes to build in the body. Signs and symptoms of acute kidney injury can include low urine output, or swollen legs or feet. FDA cautioned that people should not quit their medicine without first consulting health care professionals. Stopping medication can trigger harmful, uncontrolled blood sugar levels.

Invokana Adverse Events

FDA requests that healthcare professionals and patients report adverse events or side effects related to the use of these drugs. Reports can be made to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Invokana increases Amputations

At least one study has found that Invokana increases amputation risk for type 2 diabetes sufferers.

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Johnson’s Flagship Product Trouble

Johnson and Johnson’sTalc Powder Lawsuit Baby Powder is arguably the company’s flagship product. So much of Johnson’s branding the public has been a result of its long, successful ad campaigns to promote its baby powder, and, with that powder, the idea that the ‘consumer’ can trust Johnson & Johnson entirely. If one can trust Johnson & Johnson to powder one’s baby, one can trust the company with anything, right?

 

Johnson’s Baby Powder Invention

Frederick Barnett Kilmer, Johnson’s Director of Scientific Affairs (1889 – 1934) was  “responsible for JOHNSON’S® Baby Powder,” according to J&J’s web site.  Dr. Kilmer, says the site, suggested sending tins of Italian talc to customers “to soothe their skin.”  Customers then wrote to tell Johnson, according to J&J, “that the powder also soothed their babies’ bottoms.”  (Talk about early branding!)

 

J&J’s Facts vs. Reality

Johnson’s web site posting of Feb. 24, 2016, titled “The Facts about Talc Safety” is clearly designed to assuage growing public fears about the safety of its talc after three juries have found the company failed to warn about the link between talc and ovarian cancer. Johnson explains in its “Facts” that J&J baby powder is made from “cosmetic talc,” is one of Johnson’s oldest products, and is a “longtime part of baby care rituals.” (Bandwagon fallacy alert)  Johnson also claims on its “Facts” post that baby powder is “an essential part” of “makeup and skin care routines.”  Is that a fact?

The word “essential,” according to the Merriam-Webster Dictionary, means “extremely important and necessary.”  (See: Merriam-Webster/essential)

Baby Powder NOT Essential

By what stretch of the imagination is baby powder or talcum powder “extremely important” or “necessary”?  Do people who fail to use talc sicken or perish?  What planet does Johnson live on to make such an obviously false claim?  Talc and baby powder carry no weight whatsoever in the world of what is “necessary.” How full must a corporate entity be of its own propaganda to believe that its superfluous, unnecessary product is necessary?

J&J has clearly forgotten, or is not familiar with, Rule Number 2 from the classic movie Scarface:  “Never get high on your own supply.”

In its “Facts” blog, Johnson also asserts several things, among them:

* JOHNSON’s talc products do not contain asbestos. (Since) the 1970s, talc used in consumer products has been required to be asbestos-free.  JOHNSON’S® Baby Powder products contain only U.S. Pharmacopeia (USP) grade talc, which meets the highest quality, purity and compliance standards.

*     The safety of talc is based on a long history of safe use and decades of research by independent researchers and scientific review boards.

*     The Nurses’ Health Study (2010) and the Women’s Health Initiative Observational Cohort (2014), the only two large-scale prospective studies looking at talc and ovarian cancer, found no causal relationship between talc and ovarian cancer.

What is Talc?

J&J explains on the site that talc is a naturally occurring mineral, chemically referred to as hydrated magnesium silicate. Talc has the formula H2Mg3(SiO3)4 or Mg3Si4O10(OH)2. Talc is a highly stable, chemically inert, odorless white powder [Though some would argue that nothing in this world can be considered entirely inert]  and is the world’s softest mineral.

J&J says, “The grade of talc used in cosmetics is of high purity, comparable to that used for pharmaceutical applications, and is free from asbestos and asbestiform fibers. Cosmetic grade talc is only mined from select deposits from certified locations, and milled to relatively large, non-respirable particles size.”

J&J allows Reader Comments

The end of J&J’s “Facts about Talc Safety” piece allows for some readers’ comments, many of which reference the trial cases Johnson has lost regarding talc’s link with ovarian cancer.  All three juries which have heard talc-ovarian cancer cases have agreed that J&J failed to warn that its baby powder talc is linked to an increased risk of ovarian cancer.

Some 49 comments follow J&J “Facts about Talc Safety.”  To Johnson’s credit, it has allowed publication of not only glowing tributes for J&J, but also comments highly critical of the company’s handling of the talc controversy. Here is a sampling:

Stephan Morin, February 25, 2016:
Just like coorporate America. The ALMIGHTY DOLLAR dictates who live and who dies. Is this what they call collateral damage? At what cost J&J?

Seywonh Smith, February 24, 2016:
Lost my Mom in Aug at 71. She used Baby powder and shower to shower powder for years for feminine hygiene. I do not have BRCA 1 or 2 gene nor did she. She died from Ovarian Cancer, shame on Johnson & Johnson for killing my Mom for a buck.

Looking for alternatives, February 25, 2016:
I’ve been using Johnson and Johnson powder since I was born. I’m terrified now to use the talc powder despite these assurances. (I) feel deeply betrayed by this company which I associated with care and comfort. To read reports that executives knew of a causal link between talc and ovarian cancer as early as the 1980s leaves me saddened and distressed.

Jeannie Whitfield, February 24, 2016 
I have been using J&J Baby Talc daily since 1951 non-stop except for surgery (No perfume) and have never had a single problem and yes it’s mainly for my private parts with great success at being hygenic. (There) must be thousands like myself so why not hold a survey about us?

Elizabeth Foley-Saxon, February 29, 2016:
My husband, daughters and I have used Johnson’s baby powder for many, many years. I just learned of the association between talc and ovarian cancer, and I’m SO disappointed. Even if the risk is small, it’s too much risk to assume. Ovarian cancer is the deadliest of gynecological cancers! The moment that this risk became known, J&J should’ve taken action. This is NOT what you did. You put the bottom line of your corporation before the health of your customers. Our bottles of powder have gone into the trash, and I have purchased talc-free powder. Shame on you!

Talc Powder Lawsuits

Some 1,000Talcum Powder Ovarian Cancer or so lawsuits have been filed in state and federal courts in which women or their surviving family members allege that talc use for feminine hygiene caused ovarian cancer. Ovarian cancer is a rare but deadly form of cancer. In the three court cases so far, all of which have gone against Johnson, juries appear to have been swayed by studies but also by J&J’s internal documents which have revealed that the company knew and was concerned about the link between talc and ovarian cancer back in the early 1980s if not before that time.

Johnson, meanwhile, is sticking to its guns and defending talc as completely safe. The company, at this point, would appear to have little choice but to do so, to deny that there is anything inherently dangerous about talc. If Johnson’s flagship product is shown to cause cancer, and if the majority of the public were to believe that talc is linked with cancer, Johnson’s continued branding of millions of people to continue to sell them billions of dollars in products could be in real danger. At the very least, J&J profits could fall, and that is, of course, the last thing that Johnson wants to see happen.

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Androgel Testosterone MDL

Lawsuits against androgel-bottleAbbieVie, Inc. – the maker of Androgel – and four other pharmaceutical companies making testosterone replacement therapy drugs have been centralized into a multi district litigation court (MDL) in Illinois. Some 3,500 product liability cases are filed in the federal court system for claims against makers of the “Low-T replacement therapy.” Plaintiffs include both testosterone therapy users and insurance companies.

 Low T Replacement Therapy

Several forms of testosterone replacement therapy remain on the market. They include oral agents, injectable agents, and topical delivery, typically creams. AndroGel is a topical agent that was approved by the FDA in 2011. It is one of the most popular products designed to treat low testosterone levels. Androgel is primarily prescribed to men who fail to produce sufficient amounts of testosterone themselves. The gel, a blend of synthetic testosterone and alcohol, is applied to the skin once a day. It can cost some $500 per month.

Testosterone Therapy Problems

After testosterone therapy products had been on the market for roughly two years, more and more doctors began to discuss the dangerous side effects. Older men were using Low T therapy to regain youth, boost energy, increase sex drive – reasons for which it was not ostensibly designed. The largest risks associated with testosterone supplementation include an increase in cardiovascular problems such as heart attacks and strokes. Other risks include prostate cancer, larger red blood cells, reduced sperm count, gynecomastia (breast growth), edema, sleep apnea, high cholesterol.

 Androgel / Abbott Lawsuits

Five men aged 50-63 sued Abbott Laboratories and AbbVie, Inc. in 2014 in the U.S District Court for the Northern District of Illinois. They alleged their injuries were caused by AndroGel. Two of the plaintiffs suffered heart attacks, two suffered strokes; all said Androgel caused the problem, and that Abbott and AbbVie failed to warn them about the risks associated with AndroGel. Their petition said the companies knew or should have known about the risks posed by testosterone therapy. Their complaint charges that the company downplayed the known health risks and deceived consumers. Testosterone marketing included testimonials from professional athletes the same ages as the ad-target group.

 Studies show Significant Risks

The founder of Public Citizen’s Health Research group, Dr. Sidney Wolfe, published a piece in the British Medical Journal regarding testosterone therapy. Dr. Wolfe said his research uncovered 27 studies done on testosterone drug safety. The thirteen studies funded by drug companies showed no increased heart risks, but fourteen studies funded independently showed a significant increase in heart risks.

NIH: Testosterone doubles Heart Attack Risk

The National Institutes of Health funded an epidemiologic study based on the records of 55,000 men who had taken testosterone. The NIH found that for men over 65 the relative risk of heart attacks from Low T thereapy for three months doubled the risk they had the year before using testosterone; and the therapy more than doubled the heart attack and stroke risk for men under 65 who had a history of heart disease.

Insurance Companies sue Low T Product Makers

Insurance companies in the MDL allege the defendants created testosterone replacement therapy products to treat a fictitious disease called ‘Andropause.’ The insurance companies claim ‘symptoms’ of the ‘disease’ are only facts of the male aging process; they are therefore non existent or medically unnecessary. The insurers also claim violations of Racketeer Influenced and Corrupt Organizations (RICO) Act. They say Androgel was aggressively marketed despite being ineffective as well as dangerous.

Androgel Testosterone MDL

Defendants for the trial cases seek to set deadlines for complete fact discovery and expert discovery from July 2016 to February 2017. They want deadline for Daubert motions (re: expert witnesses) set from September 2016 to September 2017. Plaintiffs argue that these dates represent significant delays that would needlessly slow the MDL progression. Plaintiffs wish to try these cases as soon as possible.

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Invokana $1 Billion Lawsuit Filed

An Invokana $1 billion lawsuit Billion Lawsuit Filed">Invokana-197x300was filed against J&J’s Janssen Inc. in Canada in September 2015. The petition alleges patients suffered serious Invokana side effects, and seeks class-action status.

Ontario resident Rosalba Joudry alleges in her petition that Janssen did not conduct adequate long-term studies on the effects of Invokana on kidney health. She charges that Janssen further failed to provide adequate warnings about Invokana side effect risks. Her suit alleges Janssen failed to conduct any prospective or retrospective population studies, animal studies or trial studies for Invokana; failed to hire experts to examine the drug; failed to review or take action on information regarding the risk of drugs in Invokana’s class of SGLT2 inhibitors.

Ms. Joudry’s lawsuit states: “Even if the probability of injury is small or may only affect a small group of users, this risk must be balanced against considerations such as the nature of the drug, the necessity for taking it, the seriousness of the danger, and the magnitude of the increased danger to the consumer.”

Invokana Risks downplayed – Lawsuit

Ms. Joudry’s petition further alleges that Janssen ignored information regarding side effects and downplayed the seriousness of potential side effects; instead, the company promoted Invokana as safe. The lawsuit charges that Invokana is an unreasonably dangerous drug that should never have been marketed.

Ms. Joudry’s doctor prescribed her Invokana in 2014 to help manage her type 2 diabetes. While taking Invokana over the first few months, she learned through a television ad about the risk of kidney problems, underwent tests, and was subsequently diagnosed with kidney failure. Ms. Joudry says she would not have taken Invokana if she had known about the risks.

CBC News reported on September 17, 2015 that the Canadian lawsuit seeks more than $1 billion on behalf of patients allegedly harmed by Invokana.

Invokana $1 Billion Lawsuit Filed

Another Invokana lawsuit this one pursued not as a class action but as an individual case, was filed by Jennifer Anzo in California. Ms. Anzo alleges Janssen marketed Invokana as safe and effective, while it was linked to serious complications that include kidney failure. Ms. Anzo’s legal petition says she developed diabetic ketoacidosis as a result of using Invokana. She says she was subsequently hospitalized with severe dehydration, severe abdominal pain, low blood pressure, and tachycardia. Ms. Anzo also says she would not have taken Invokana had she had known about its risk of complications. Her suit seeks as yet unspecified damages.

The California lawsuit lawsuit is Anzo v. Janssen Research & Development, LLC, et al., Case number 2:15-at-01102, in US District Court, Eastern District of California.

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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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