Johnson & Johnson Can’t Win in Court

The hits keep coming for pharmaceutical titan Johnson & Johnson, which has suffered a series of huge legal and financial blows in 2016. A slew of jury awards and settlements have cost the company hundreds of millions of dollars and severely damaged its credibility in the court of public opinion.

J&J is struggling to fight three mammoth legal battles at once, and the strain is showing both in its courtroom performances and in its bank account.

Hold J&J Accountable

J&J Will Try—Again—to Move Talc Cases Out of St. Louis

After three massive awards for plaintiffs who claimed they contracted ovarian cancer from using Johnson & Johnson’s talc-based products, J&J will attempt to move future talc cases out of Missouri. They tried this once before, last August, arguing that the company and plaintiffs had no ties to St. Louis. The judge dismissed the motion.

The most recent jury award, in October, was $70 million to Deborah Giannecchini. Five months prior, a Missouri jury awarded Gloria Ristesund $55 million.

The first big win for plaintiffs, in February 2016, went to the family of Jacqueline Fox, a woman who passed away from ovarian cancer after a lifetime of using Johnson & Johnson’s Baby Powder for feminine hygiene. Ms. Fox’s family received $72 million.

There are more than 1,000 talcum powder lawsuits pending in St. Louis, and 200 more awaiting their day in New Jersey courts.

Attorney Jere Beasley, whose firm filed the three Missouri cases and hundreds of others, told Fortune, “If I were representing them [Johnson & Johnson], I would say, folks, we need to sit down and regroup and start trying to settle these cases.”

But as of this writing, J&J seems more concerned with upholding its image as a wholesome family company than admitting wrongdoing and reimbursing the hundreds of women who say they have contracted ovarian cancer from using talc products.

J&J Settles Another Risperdal Lawsuit, Avoiding Trial

Talcum powders aren’t the only Johnson & Johnson products that have spawned a mountain of litigation. The antipsychotic drug Risperdal has allegedly caused many young boys to grow breasts, a condition known as gynecomastia. Hundreds of these boys have filed Risperdal lawsuits against J&J, and so far, they have been very successful in obtaining relief.

In July, a Philadelphia jury awarded Andrew Yount a staggering $70 million, ruling not only that J&J had failed to warn Mr. Yount of the risks in taking Risperdal, but that the company had concealed or destroyed evidence related to the case. Mr. Yount, of Tennessee, started taking Risperdal when he was just five years old.

A Philadelphia jury found that J&J had concealed or destroyed evidence related to the Andrew Yount case.

Mr. Yount’s award was the latest in a string of wins for Risperdal plaintiffs. Nicholas Murray was awarded $1.75 million in November 2015, and Austin Pledger was awarded $2.5 million in February 2015.

Perhaps still smarting from all of those losses, earlier this month Johnson & Johnson reached an undisclosed settlement to end a Risperdal case filed by a man who started taking the drug at age seven to manage symptoms brought on by his Asperger’s syndrome. According to court documents, the plaintiff developed permanent gynecomastia.

That is one of dozens of Risperdal cases that J&J has opted to settle out of court.

In November 2013, Johnson & Johnson paid a $2.2 billion fine to settle a Justice Department investigation into its promotion and marketing of Risperdal. This was one of the largest such fines in American pharmaceutical history.

There are 1,500 Risperdal lawsuits still pending in U.S. courts.

Hip Replacement Cases Cost $4.15 Billion and Counting

The most expensive legal battle of all, though, keys on Johnson & Johnson’s defective hip implants. In 2013, J&J settled thousands of claims about its Depuy ASR implants for an estimated $4 billion.

That model is not the only one creating pains for patients and headaches for J&J, though. Johnson & Johnson’s Pinnacle hip implant has generated 8,400 lawsuits, the vast majority of which are currently pending in multi-district litigation (MDL).

A bellwether Pinnacle case recently made it to trial, where a jury awarded plaintiffs $500 million in damages.

One bellwether case, though, recently made it to trial, where a jury awarded five plaintiffs $500 million in damages. (A Texas judge later cut that award to $151 million.) Another bellwether Pinnacle trial went to court in September; there has been no word yet on a verdict. Legal experts feel that another loss for J&J could prompt the company to settle the remaining 8,400 suits.

If you or a loved one have suffered unforeseen physical or financial harm because of Johnson & Johnson hip implants, talc products, or its drug Risperdal, please contact us today to explore your options. Don’t wait; you could qualify for compensation.

Clinical Trials Likely to Be Focal Point in Xarelto Lawsuits

Although the legal strategy of Xarelto plaintiff attorneys won’t become clear until the first trials begin in early 2017, it appears that the quality—or seeming lack thereof—of clinical trials used to approve Xarelto (rivaroxaban) will be a key issue. One particular point of emphasis could be a lack of quality data supporting once-daily Xarelto dosing, something drugmakers Bayer/Janssen claim makes Xarelto more convenient but could cause life-threatening side effects.

Xarelto’s once-daily dosing makes the blood thinner more convenient, but could also make it more dangerous.

Xarelto and other so-called “novel anticoagulants” are vying to replace the older blood thinner Coumadin (warfarin) largely on the grounds that they are easier to use than warfarin. Blood thinners are prescribed to patients at risk for developing blood clots and suffering related complications such as stroke and deep vein thrombosis.

Xarelto does not require medical monitoring to ensure patient safety, whereas warfarin patients must be monitored once or twice per month for blood clot risks and have their dosage adjusted accordingly. Another purported benefit of Xarelto over warfarin is its once-daily dosing, something that makes Xarelto more user-friendly—and thus more marketable—but according to some critics makes the drug more dangerous.

Xarelto’s Short Half-Life

The dosing problem has to do with Xarelto’s relatively short half-life of 5-9 hours. Other new coagulants such as Pradaxa and Eliquis have a half-life of 12-17 hours, while warfarin has a half-life of 20-60 hours.

A short half-life means that a drug’s concentration in the body diminishes rather quickly. This leads to drug “peaks” (high drug concentrations) and “troughs” (low drug concentrations). Fluctuations in drug concentration present a twofold risk: of bleeding (when concentrations are high), and of lower blood clot prevention efficacy (when concentrations are low).

According to one study, at its peak the amount of Xarelto measured in the blood was 16.9 times higher than at its trough. For Eliquis (abixaban), which is administered twice per day, the peak was 4.7 times higher than the trough.

FDA staff clearly identified this issue during the approval process but decided to clear Xarelto for sale because clinical trial data indicated it had a safety profile that was no worse than warfarin.

But while the overall safety of the drugs was comparable in premarketing studies, postmarketing adverse event data shows what would be expected of a drug with a short half-life and once-daily dosing. According to data provided by the Institute for Safe Medication Practices (ISMP), compared to other blood thinners, Xarelto has a significantly higher frequency of treatment failure events (embolic-thrombotic events, or blood clot events), an apparent outcome of a “trough.”

Potential side effects of rivaroxaban “peaks,” which may lead to excessive levels of the drug in some patients’ bodies,  are especially concerning when considered alongside Xarelto’s lack of a reversal agent. Plaintiffs in Xarelto lawsuits commonly claim that they were not properly warned about the lack of a Xarelto bleeding antidote. If serious bleeding occurs with warfarin, the drug’s effect is easily reversible.

Bad Dosing Data

FDA reviewers noted that the “the clinical relevance was uncertain” in regards to the safety profile of Xarelto 10 mg twice daily versus Xarelto 20 mg once daily. The reason for their uncertainty? In the pivotal trial (ROCKET AF study) used to support Xarelto’s approval, only the once-a-day regimen was tested.

One study did compare once daily dosing with twice daily dosing, but according to an attorney representing Xarelto lawsuit plaintiffs, the study was on par with “an elementary school science fair project” due to numerous shortcomings, including missing data.

One attorney compared Xarelto clinical trials to “an elementary school science fair project.”

An article published in the Journal of the American College of Cardiology reviewed the trial-in-question (the ATLAS ACS 2–TIMI 51 Trial) and found that “an unanticipated high rate of missing data, particularly the vital status of patients, precludes reliable and valid information.” The article also found that “there was a lack of an expected dose response—the 5-mg dose did not have greater efficacy compared with the 2.5-mg dose of rivaroxaban.”

So why, in spite of inadequate safety and efficacy data, is Xarelto recommended for once-daily dosing? It could simply be a marketing ploy. Once-a-day dosing helps to sell the idea that Xarelto is more convenient than competitors.

If plaintiff attorneys are able to poke holes in Xarelto clinical trials and show that Bayer/Janssen should have provided stronger warnings about the potential side effects associated with once-daily dosing, they may have success in the initial Xarelto trials that are scheduled for February and March 2017.

Questions about Xarelto litigation? Interested in filing a claim? Get in touch with ClassAction.com and learn your legal options.

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(Sources: ISMP Quarter Watch; FDA; JACC; PennRecord)

Studies Link Big Pharma Money With Brand Name Drug Prescribing

New research is confirming what many have long suspected: doctors who take money from BigPharma tend to prescribe brand name drugs at higher rates than doctors who do not accept drug company payments.

“You want your doctors to be objective rather than doing something because there is a financial gain, be it subconscious or conscious.”

Improved transparency laws are shedding light on physician-industry relationships and igniting debate about the propriety of these ties. While not illegal, industry payments can lead to decreased patient trust, increased drug costs, and other negative health care outcomes. There’s also no evidence that branded drugs work better than generic equivalents or produce greater patient satisfaction.

While a Harvard study suggests there is a positive correlation between the amount of industry money received and the rate of brand name prescribing, a study out of the University of California shows that even a single meal can make a difference. Both studies confirm a first of its kind analysis performed by ProPublica.

Harvard Study Associates Industry Payments With Branded Statin Prescriptions

Dr. James S. Yeh and colleagues from Harvard Medical School set out to determine the association between drug company payments to physicians and the prescribing of brand name vs. generic statin drugs by analyzing Massachusetts Part D Medicare prescriptions claims data and the state’s physicians payment database.

They found that doctors’ rate of prescribing brand name statins increased 0.1% for every $1,000 in industry money received. Payments for educational training were associated with a 4.8% uptick in brand name prescribing rates. The researchers called their findings, published in JAMA Internal Medicine, “concerning.”

“You want your doctors to be objective rather than doing something because there is a financial gain, be it subconscious or conscious,” Dr. Yeh told ProPublica.

Not only are prescription drugs significantly more expensive than generics, but patients are also less likely to continue taking costlier drugs, which can lead to worse patient health outcomes.

Yeh and ProPublica caution that the study results don’t necessarily show a causal relationship between doctor payments and brand name prescribing, because the data alone can’t account for factors such as why a doctor chose a particular drug, or whether pharmaceutical companies target doctors who already prescribe brand name drugs in higher numbers.

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UCSF Study: Meals Lead to Promoted Drug Prescriptions

Most industry payments to doctors are not supplied in the form of cold hard cash. Instead, payments tend to be provided as speaking fees, consulting compensation, travel and lodging for company-sponsored training events, tickets to shows, charitable contributions, and meals.

A meal might not seem like enough to sway a doctor’s prescribing patterns, but according to a new study out of the University of California San Francisco, a single drug company lunch worth less than $20 could convince a doctor to prescribe a promoted drug over competitors.

Published in JAMA Internal Medicine, the study analyzed 2013 data from the federal Open Payments Program and Medicare Part D associated with three brand name cardiovascular drugs (Crestor, Pristiq, and Benicar) and one brand name anti-depressant (Pristiq). It concluded that doctors treated to a single industry-sponsored meal promoting the drug of interest were significantly more likely to prescribe that drug. The more meals doctors received, the more likely they were to prescribe the promoted drug. Each of the drugs had lower-cost generic alternatives.

“I don’t think there is a doctor out there who thinks, ‘I can be bought for a hero or a slice of pizza.’”

Physicians receiving just one meal promoting the drug of interest were 18% more likely to prescribe AstraZaneca’s Crestor over an alternative, 52% more likely to prescribe Daiichi Sankyo’s Benicar, 70% more likely to prescribe Allergan’s Bystolic, and 118% more likely to prescribe Pfizer’s Pristiq.

According to the study authors, industry-sponsored meals account for about 80% of the total number of industry payments to physicians. The findings are important because they suggest that it doesn’t require hefty consulting fees or lavish entertainment to influence doctor prescribing trends. A single lunch appears sufficient to provide a big payoff for drug companies.

Lead author R. Adams Dudley, told the Wall Street Journal, “I don’t think there is a doctor out there who thinks, ‘I can be bought for a hero or a slice of pizza.’” But Dr. Dudley added that it is human nature for a doctor to listen to the pitch of a sales representative who provides a free meal, and this can affect prescribing patterns.

The authors stress the findings represent an association, not cause-and-effect, but in an accompanying editorial JAMA Internal Medicine editor-at-large Robert Steinbrook said proving a causal relationship may not be necessary.

“There are inherent tensions between the profits of health care companies, the independence of physicians and the integrity of our work, and the affordability of medical care,” wrote Steinbrook. “If drug and device manufacturers were to stop sending money to physicians for promotional speaking, meals, and other activities without clear medical justifications and invest more in independent bona fide research on safety, effectiveness, and affordability, our patients and the health care system would be better off.”

ProPublica Analysis Confirmed

It may seem obvious that drug company payments affect doctor prescribing patterns, but until this year proof for the trend has been lacking.

ProPublica in March 2016 published the results of an extensive analysis that shows money from the medical industry results in doctors prescribing a higher percentage of brand name drugs.

According to the analysis, which looked at doctors across five common specialties who wrote at least 1,000 prescriptions in Medicare’s Part D drug program, doctors who received more industry money tended to prescribe brand name drugs at a higher rate. The highest percentages of brand name prescribing were associated with payments of $5,000 or more, but even a single meal was correlated with a higher brand name prescribing rate. Overall, doctors who received industry payments were two to three times more likely to prescribe brand name drugs at very high rates as other doctors in the same field, the analysis shows.

ProPublica’s research, “confirms the prevailing wisdom…that there is a relationship between payments and brand name prescribing,” said Dr. Aaron Kesselheim of Harvard Medical School. “This feeds into the ongoing conversation about the propriety of these sorts of relationships. Hopefully we’re getting past the point where people will say, ‘Oh, there’s no evidence that these relationships change physicians’ prescribing practices.’”

Although the analysis does not prove that industry payments cause doctors to prescribe specific drugs or a specific drug company’s products, it shows that doctor payments in general benefit Big Pharma’s profits.

“There is a very good reason why drug companies spend billions of dollars on their sales and promotional efforts: the strategy works,” said James D. Young, an attorney for Morgan & Morgan.

Branded Drugs Not More Effective Than Generics

Name brand drugs, in spite of their higher price tag, do not work any better than generics, research indicates. There also isn’t much difference between name brand and generic drugs in terms of patient satisfaction.

Generic drugs, furthermore, may have a better-understood safety profile. In order to be sold as generics, drugs must be on the market for many years, and this real world use is very effective at picking up on potential side effects. The safety of newer drugs, on the other hand, is largely based on clinical trials with smaller population sizes that may underrepresent poor patient outcomes in the real world.

“Next time your doctor writes a prescription for a brand drug, ask her why she chose that drug over generics or competitors.”

Another potential benefit of generic drugs is lower health care spending. The multi-million dollar direct-to-consumer ad campaigns that promote brand name drugs over less expensive treatments are blamed in part for rising prescription drug prices. For example, in 2015, brand name drug costs increased 15.8%, compared to a 6.6% increase in generic drug costs. Generic drugs cost on average 15 to 60 percent less than brand name drugs.

Finally, studies show that the mere belief that physicians are receiving industry money can undermine a patient’s faith in their doctor. A 2012 study, for instance, found that more than half of patients surveyed said they would have less trust in their physician if they found out he or she accepted gifts, went on industry-sponsored trips, or received sporting event tickets.

So what can you do if you want to know more about your doctor’s industry ties? James Young of Morgan & Morgan encourages patients to challenge their doctor’s prescribing habits.

“Next time your doctor writes a prescription for a brand drug, ask her why she chose that drug over generics or competitors,” says Young.

Patients can also check the government’s Open Payments Database to find out how much drug companies are paying their doctor. ProPublica offers a similar tool through their Dollars for Docs project.

Hundreds of Boys Grow Breasts After Taking Risperdal

For five years, Shaquil Byrd had to protect himself from bullies. Now he’s going after the source of his torment: Johnson & Johnson.

At the age of nine, Mr. Byrd (now 22 and living in Albany, New York) was prescribed Risperdal to treat his mental health issues: depression, ADHD, and bipolar disorder. Soon after he started taking the drug, Mr. Byrd grew breasts—a condition known as gynecomastia.

Though J&J knew Risperdal could have this side effect, they did not add a warning to its label until 2006. By that point, the drug had been prescribed to hundreds if not thousands of young men.

Hold J&J Accountable

At times, Mr. Byrd’s breasts would lactate. For five years—from 2002 until he stopped taking Risperdal in 2007—Mr. Byrd was mocked and harassed by classmates. His confidence wilted, and his self-image became warped.

“He did a lot of crying,” Mr. Byrd’s mother, Eugenia Jordan, told WNYT. “He was very uncomfortable around other people.”

Byrd Fights Back

In 2014, Mr. Byrd had his breasts surgically removed: a big step forward in his recovery from this trauma. He also filed a lawsuit against Johnson & Johnson—one of roughly 1,600 the company has faced in the wake of Risperdal’s traumatic side effects.

Incredibly—despite their own research and others’, the evidence in this case, and the scores of similar cases—J&J denies all wrongdoing, stating

We believe there is no evidence that RISPERDAL® caused any harm to this patient, who stopped taking the medication eight years before receiving a diagnosis of gynecomastia. We will continue to defend ourselves in this litigation.

Johnson & Johnson claims Mr. Byrd received a gynecomastia diagnosis eight years after he stopped taking Risperdal—which would be 2015, a year after he’d had his breasts surgically removed. They either don’t have their facts straight, or they are deliberately distorting them.

If history is any indication, this “family company” is once again manipulating data for its own gain.

Fight Back

J&J Fined $2 Billion for Unlawful Marketing

In 2000, Johnson & Johnson learned that 5.5% of boys taking Risperdal long-term eventually developed breasts. But the Risperdal label said that this occurred in 0.1% of boys. By 2000, more than one-fifth of Risperdal users were children and adolescents.

Risperdal wasn’t FDA-approved for children in 2002, when a doctor prescribed it to Shaquil Byrd. (Off-label prescriptions are legal; off-label promotions by drug makers are not.) But that didn’t stop J&J from marketing it to kids, a significant chunk of whom would contract gynecomastia. This callous disregard would wind up costing the company billions.

From 1999 to 2005, the FDA repeatedly warned J&J about promoting Risperdal for use by young people. During this time, the Justice Department says that Janssen promoted Risperdal for use in children and individuals with mental disabilities, despite the company knowing that Risperdal posed “certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development.”

In 2013, J&J settled 77 lawsuits filed by men who had taken Risperdal and experienced unwanted (and undisclosed) side effects. Later that year, Johnson & Johnson settled a Justice Department investigation into its promotion and marketing of Risperdal by paying a $2.2 billion fine—one of the largest in American pharmaceutical history.

Recently, the filmmakers behind the hit Netflix documentary Making a Murderer announced their next subject: Johnson & Johnson’s manipulative and heartless promotion of Risperdal, as covered in great (and painful) detail by Steven Brill at The Huffington Post.

The name of the article: “America’s Most Admired Lawbreaker.”

Hold J&J Accountable

Alabama Man Awarded $2.5 Million After Growing 46DD Breasts

Johnson & Johnson probably wishes it had settled Austin Pledger’s lawsuit.

Like Shaquil Byrd, Mr. Pledger—an autistic young man from Alabama—grew breasts after taking Risperdal as a child, in 2002. Like Mr. Byrd, he was ridiculed by his peers for his breasts, which eventually grew to be size 46DD.

And like Mr. Byrd, Mr. Pledger (now 21) filed a lawsuit against J&J to hold them accountable for their egregious disregard and concealment of Risperdal’s potential side effects.

A Philadelphia jury sided with Mr. Pledger: in February 2015, they awarded him $2.5 million in damages.

During the trial, former FDA chief David Kessler testified that J&J knew as early as 2001 that Risperdal could cause gynecomastia in as many as 5.5% of Risperdal users, but did not add a warning to the drug’s label until five years later, in 2006.

Mr. Pledger may have won the trial, but he still hates his body. He idolizes his father, but when he looks in the mirror, he sees his mother. As Mr. Byrd did, Mr. Pledger will likely have to undergo a mastectomy in the near future.

No amount of money can give him his body back, or take away the years of bullying and self-loathing he has suffered.

1,600 Risperdal Cases Still Pending in Philadelphia

Austin Pledger’s case was one of more than 1,600 that now await trial in Philadelphia. The sheer volume of plaintiffs serves as a powerful indictment of Johnson & Johnson—as does J&J’s internal handling of the Risperdal issue.

The man responsible for Risperdal’s unlawful marketing was Alex Gorsky. Instead of punishing or firing Mr. Gorsky for the damage he inflicted on hundreds of young boys (and the elderly, who are vulnerable to strokes if they take Risperdal), Johnson & Johnson promoted him to CEO.

Today, Mr. Gorsky is still CEO. While victims like Shaquil Byrd and Austin Pledger have to hire lawyers, go to court, and fight to win compensation for medical bills and psychological trauma, Mr. Gorsky happily takes home more than $25 million a year. (One can’t help but wonder how the man sleeps at night.)

Our law firm, Morgan & Morgan, doesn’t think that’s right. We are one of the largest personal injury firms in the country, and we aim to hold Johnson & Johnson accountable for their actions.

If you or a loved one has suffered side effects after taking Risperdal, please contact us. Don’t wait; these cases are time-sensitive, and you may be entitled to compensation.

How to Find Out If Your Doctor Is on the Payroll of Big Pharma

Nestled within the 20,000+ pages of the Affordable Care Act (aka “Obamacare”) is something known as the Physician Payments Sunshine Act.

The Sunshine Act mandates that manufacturers of drugs and medical devices disclose payments to physicians of more than $10. It also requires that drug and device maker payment data be posted on a publicly accessible website administered by the Centers for Medicare and Medicaid Services (CMS). These provisions are intended to help patients make better-informed healthcare decisions and to discourage financial ties that could increase health care costs.

As the New England Journal of Medicine (NEJM) explains, patients who find out that their doctor is involved with industry might trust the doctor less and be less inclined to accept treatment recommendations or care from them. “Given the evidence that greater physician financial involvement with manufacturers is associated with higher utilization of expensive, brand-name products, such dynamics could reduce costs,” writes NEJM.

With U.S. healthcare costs skyrocketing, and with high brand name drug costs a major culprit, the cost-lowering aspect of transparency is certainly important. But beyond that, patients simply have a right to know whether their doctor is taking medical industry money. What they do with that information is up to them. Without adequate knowledge, however, transparency is impossible.

Here’s how to find out if your doctor is taking money from Big Pharma:

  1. Visit OpenPaymentsData.CMS.gov
  2. Enter the first and last name of your doctor
  3. Click “Search”
  4. Find and click your physician’s name in the records results
  5. If multiple results appear, click “refine your search criteria,” add more information, and repeat the search

Alternately, patients can visit ProPublica’s “Dollars for Docs” website and search by doctor, drug, or device.

ProPublica, using data obtained through the CMS Open Payments tool, recently published an analysis that shows the more money doctors receive from the medical industry, the more they prescribe brand name medications.

While this may not seem like an earth-shattering finding, the evidence for it up until now has been piecemeal. Prior to the Sunshine Act, there was no centralized mechanism for tracking physician payments from drug and device companies.

According to ProPublica, from August 2013 to December 2014 alone, pharmaceutical and medical device companies made $3.49 billion in payments to more than 680,000 doctors.

Doctors tend to deny that financial influences have any bearing on what they recommend to patients. ProPublica says their analysis doesn’t prove industry payments sway physicians to prescribe certain drugs or a particular company’s drugs, but that overall, payments benefit drug companies’ bottom line.

In a health care system that should be serving the people, and not the powerful, this is reason enough to discourage financial ties between the medical industry and doctors.

“There is a very good reason why drug companies spend billions of dollars on their sales and promotional efforts: the strategy works,” says James D. Young, an attorney for Morgan & Morgan who is nationally recognized for his work in pharmaceutical litigation.

Young adds, “The next time your doctor writes a prescription for a brand drug, ask her why she chose that drug over generics or competitors.”

Studies Link Invokana to Diabetic Ketoacidosis, Toe Amputations

A study published in the journal Diabetes Care has found that Johnson & Johnson diabetes drug Invokana (canagliflozin) increases the incidence of diabetic ketoacidosis (DKA) in patients with type 1 diabetes.

The finding comes nearly a year after the Food and Drug Administration (FDA) warned that Invokana and other diabetes drugs may lead to DKA, a potentially fatal condition. Meanwhile, in Europe, the FDA’s counterpart is investigating the link between Invokana and toe amputations.

Hold J&J Accountable

Dr. Anne L. Peters and colleagues at the University of Southern California Keck School of Medicine performed a placebo-controlled, double blind trial that aimed to determine how canagliflozin (an add-on to insulin for patients with type 1 diabetes) impacts glycemic control and weight, as well as the incidence of DKA.

“People with type 1 diabetes who use an SGLT-2 inhibitor are at increased risk for DKA, which appears to be dose related.”

Chemicals called ketones are produced when cells are glucose-starved and begin to burn fat for energy. This occurs when the body doesn’t have enough insulin to use glucose, the body’s normal energy source.

Ketone accumulation makes the blood more acidic and can cause DKA, which may result in diabetic coma or even death.

USC Study Finds Increased Risk of DKA

In the Peters study, the incidence of any ketone-related event with canagliflozin at week 18 was found to be 5.1% (100 mg) and 9.4% (300 mg), while serious DKA adverse events requiring hospitalization occurred in 4.3% and 6%, respectively, of the canagliflozin group. No ketone-related adverse events were recorded for the placebo group.

Invokana belongs to a group of drugs known as SGLT-2 inhibitors. The drugs are approved to treat type 2 diabetes, but doctors are free to prescribe drugs for off-label (non-FDA approved) uses such as type 1 diabetes.

“People with type 1 diabetes who use an SGLT-2 inhibitor are at increased risk for DKA, which appears to be dose related,” Dr. Peters told Endocrine Today. “If [canagliflozin is] used in this off-label fashion, patients should be fully educated as to this risk and willing to monitor ketones at times of illness or other stress, and only the lowest dose of the SGLT-2 inhibitor should be used.”

In December 2015, the FDA issued new labeling guidelines for SGLT2 inhibitors to warn of the risk of ketoacidosis.

“Diabetic Ketoacidosis With Canagliflozin, a Sodium–Glucose Cotransporter 2 Inhibitor, in Patients With Type 1 Diabetes” is published in the April 2016 edition of the American Diabetes Association’s Diabetes Care.

European Agency Probing Invokana Link to Amputations

The European Medicines Agency (EMA), the European equivalent of the FDA, is reviewing a possible association between canagliflozin and amputations (mainly of the toe), which have been observed in an ongoing drug trial.

CANVAS (CANagliflozin cardioVascular Assessment Study) is a post-marketing clinical study designed primarily to assess the cardiovascular risks of Invokana for patients with type 2 diabetes, and secondarily to assess the overall safety and effectiveness of Invokana. CANVAS trials are being held in the U.S. as well as in Europe, Asia, Australasia, and Latin America.

EMA started a review of canagliflozin after patients enrolled in CANVAS showed an increase in lower limb amputations. The agency says that the link between canagliflozin and lower limb amputations is not confirmed, but it is looking further into the matter.

“EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from [Johnson & Johnson] to assess whether canagliflozin causes an increase in lower limb amputations and whether any changes are needed in the way this medicine is used in the EU,” the agency wrote in an April 15 statement.

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Invokana gained FDA approval for type 2 diabetes in March 2013, but the drug’s link to DKA was not made public until more than two years later. Therefore patients who took the drug and developed DKA may be able to pursue an Invokana lawsuit.

If you experienced DKA, lower limb amputation, or other adverse effects while taking Invokana, you may qualify for a lawsuit. Explore your options and find out if you are entitled to compensation during a free case review.

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