Hospitalized after taking Invokana or other Type 2 Diabetes drug?

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Hospitalized after taking Invokana or another Type 2 Diabetes drug?

Find out if an Invokana lawsuit is right for you.

Invokana burst onto the market in 2013, the first of a new class of diabetes drugs to win FDA approval. It was considered a revolutionary breakthrough, a potential game changer for those suffering from Type 2 Diabetes.

Invokana, the brand name of canagliflozin, was highly touted for its innovative approach to lowering blood sugar ― the key to controlling diabetes. It was the first version of a novel class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors, which work differently than other diabetes drugs by altering kidney function. SGLT inhibitors lower blood sugar by causing the kidneys to remove sugar (glucose) from the body through urine.

Not only did Invokana promise to lower blood sugar, but the once-a-day pill came with an added claim of inducing weight loss and lowering blood pressure. It quickly gained popularity, becoming Pharma Giant Johnson & Johnson’s newest blockbuster drug.

Did you or a loved one experience kidney failure, heart attack or stroke after taking Invokana? 877-803-2897

As studies got underway, thousands of Invokana prescriptions were filled.

Not long after, patients and doctors started reporting various Invokana problems to the FDA, which responded by issuing safety alerts and mandates for stronger warning labels about bone and kidney problems. To date, however, Invokana’s label still makes no mention about an increased risk for heart attacks or stroke, which could expose unknowing patients to a life-altering medical emergency.

Red flags were raised about potential Invokana problems before the drug hit the market.

Before Invokana was approved, some of the FDA’s own medical experts raised concerns about serious side effects, including kidney impairment, bone issues, and the increased risk for heart problems.

During a daylong meeting on January 10, 2013, the FDA assembled a panel of medical experts from the Endocrinologic and Metabolic Drugs Advisory Committee to discuss and vote on the approval of Invokana. Several safety concerns were discussed, including kidney impairment and bone issues, but some panel members also raised red flags about the drug’s potential to cause cardiovascular problems, according to official minutes from FDA panel meeting.

Specifically, clinical trials revealed multiple patients suffered from heart attacks or stroke during the first 30 days of treatment. Still, the panel voted, 10-5, to recommend approval of Invokana for the treatment of type 2 Diabetes. And just two months later, on March 29, 2013, the FDA officially approved Invokana ― on the condition that the manufacturer conduct a battery of long-term safety studies.

Can Invokana and other SGLT2 drugs cause ketoacidosis and other complications? The FDA warns, “yes.”

It didn’t take long for other SGLT2 inhibitors, such as Invokamet, Farxiga, and Jardiance, to hit the market. As millions of patients began taking these new diabetes drugs, however, reports of alarming side effects began to emerge, including:

  • Ketoacidosis, a rise in blood acidity that can lead to hospitalization, coma or death.
  • Kidney impairment, which could lead to dialysis or a kidney transplant.
  • Severe urinary tract infections, which could lead to blood and kidney infections.
  • Bone problems, such as bone fractures and decreased bone mineral density.
  • Cardiovascular issues, such as blood clots, heart attack or stroke.
  • Amputations of the leg, foot or toes.

In May 2015, just two years after its market debut, the FDA warned patients and doctors that Invokana and other SGLT2 inhibitors may lead to ketoacidosis, a serious and potentially fatal condition that produces high levels of acid in the blood. At various times in the following months, the FDA ordered SGLT2 manufacturers to add warnings to their labels about the risk for ketoacidosis, bone fractures and acute kidney injury.

FDA Adverse Event Reports

MARCH 2013 TO MAY 2015

73

CASES OF KETOACIDOSIS

101

CASES OF ACUTE KIDNEY INJURY

19

CASES OF LIFE THREATENING BLOOD AND KIDNEY INFECTIONS

Did you or a loved one suffer a life-threatening side effect after taking Invokana or other SGLT2 drug? 877-803-2897

New SGLT2 diabetes drugs linked to serious health risks after short time on market.

According to the Centers for Disease Control and Prevention, more than 29 million Americans, or 9.3 percent of the population, have diabetes. The overwhelming majority ― more than 90 percent ― suffer from the Type 2 form of the disease.

Based on these statistics alone, it should come as no surprise that pharmaceutical giants have been racing for years to develop new treatment options for Type 2 diabetics. The push eventually led to new class of diabetes drugs known as SGLT2 (sodium glucose co-transporter 2) inhibitors, which promised to revolutionize diabetes treatment by spurring diabetics to excrete excess sugar through urine.

While most Type 2 diabetes drugs work to increase insulin, SGLT2 inhibitors are completely different. They work by preventing the kidneys from reabsorbing glucose (blood sugar) back into the bloodstream. The result is that the kidneys excrete substantial amounts of glucose in the urine, thereby lowering blood sugar.

Weighing the risks vs. benefits of SGLT2 drugs

The first SGLT2 inhibitors were introduced in 2013 to great fanfare and, to date, the FDA has given the green-light to seven different drugs. But now, just three years after first hitting the market, these medications are the subject of several FDA warnings and a growing number of diabetes drug lawsuits.

Their safety is being called into question after patients reported devastating, and potentially deadly, side effects, including ketoacidosis, kidney damage, stroke, heart attack, amputations, and bone fractures. Since March 13, 2013, the  FDA has received 73 reports of ketoacidosis, 101 cases of acute kidney injury and 19 cases of life-threatening blood and kidney infections in patients taking SGLT2 inhibitors.

And while the dangers of SGLT2 inhibitors may come as a surprise to diabetics and their doctors, Big Pharma may have long known about the risks but failed to adequately warn the medical community and the public to protect their bottom line.

Numerous drug makers could be the target of diabetes drug lawsuits and investigations.

The number of diabetes drug lawsuits are expected to rise as more SGLT2-related hospitalizations and deaths are reported. The following FDA-approved drugs and manufacturers may become the focus of investigations and lawsuits:

Invokana (canagliflozin): Approved by the FDA in March 2013 and manufactured by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary.

Farxiga (dapagliflozin): Approved by the FDA in January 2014 and manufactured by Bristol-Meyers Squibb and AstraZeneca

Invokamet (canagliflozin and metformin): Approved by the FDA in August 2014 and manufactured by Janssen Pharmaceuticals

Jardiance (empagliflozin): Approved by the FDA in August 2014 and manufactured by Boehringer Ingelheim Pharmaceuticals

Xigduo XR (dapagliflozin and metformin): Approved by the FDA in October 2014 and manufactured by AstraZeneca

Glyxambi (embagliflozin and linagliptin): Approved by the FDA in February 2015 and manufactured by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company

Synjardy (empagliflozin and metformin): Approved by FDA in August 2015 and manufactured by Boehringer Ingelheim Pharmaceuticals

Is an Invokana lawsuit right for you? McDonaldLawFirm.com

Drug safety group raises questions in wake of negative reports and Invokana warning.

The Institute for Safe Medication Practices (ISMP), which analyzes negative drug reports submitted to the FDA, has also weighed in about the questionable new drug. In its May 6, 2015, edition of Quarter Watch, the drug safety group reported that within one year of the FDA’s approval, 457 negative reports were filed about Invokana – 92 percent more than the other regularly monitored drugs for Type 2 Diabetes. The negative reports included:

  • 54 reports of kidney failure or impairment
  • 54 cases of severe dehydration or fluid imbalance
  • 11 cases of kidney stones
  • 50 cases of urinary tract infections
  • 52 cases of abnormal weight loss
  • 50 cases of hypersensitivity, including allergic reactions and skin rashes.

The data prompted the drug safety group to question whether “enough is known about this agent to be assured that its benefits outweigh its risks.”

FDA: Invokana warning labels must caution about ketoacidosis, bone fractures, kidney injury.

Invokana is the most popular medication in a new class of Type 2 diabetes drugs called SGLT2 inhibitors. Its popularity is mostly due to the fact that it was first on the market, beating to the finish line numerous other similar drugs, including Invokamet, Farxiga, Jardiance, Xigduo, and Glyxambi.

Since Invokana’s approval in March 2013, an estimated eight million prescriptions have been written – but the drug is not without controversy. The Food and Drug Administration has received hundreds of negative reports about Invokana and other SGLT2 inhibitors, alleging they cause life-threatening side effects that have led to hospitalizations, dialysis and amputations.

In May 2015, just two years after making its market debut, the FDA issued its first Invokana warning, alerting doctors and patients that it may cause ketoacidosis ― an  extremely dangerous condition in which the body produces high levels of blood acids that can lead to diabetic coma or even death.

The warnings and safety communications didn’t stop there. Every few months, the FDA has made more announcements or issued more mandates in regard to safety risks associated with Invokana and other SGLT2 drugs, including:

May 2015 Drug Safety Communication: After receiving 20 reports of ketoacidosis that required hospitalization, the FDA warns patients and doctors that Invokana and other Type 2 Diabetes medications may cause too much acid in the blood.

September 2015 Drug Safety Communication: The FDA orders the maker of Invokana and Invokamet to add a warning for the increased risk of bone fractures and bone density loss to its drug labels.

December 2015 Drug Safety Communication: After identifying 73 reports of ketoacidosis and 19 cases of life-threatening blood and kidney infections, the FDA orders Invokana and other SGLT2 drug makers to update their labels to warn about the risks of ketoacidosis and serious urinary tract infections.

May 2016 Drug Safety Communication: The FDA alerts the public to another alarming problem associated with Invokana and Invokamet after receiving safety results from an ongoing trial. The trial revealed an increase in leg and foot amputations, mostly affecting the toes, in patients treated with Invokana or Invokament.

June 2016 Drug Safety Communication: The FDA orders makers of Invokana and similar Type 2 Diabetes medications to beef up their warning labels again ― this time to include information about acute kidney injuries. From March 2013 to October 2015, the FDA received 101 confirmed cases of acute kidney injury, some of which required hospitalization and dialysis.

Medical experts agree that stronger Invokana warning labes are a step in the right direction but, for many, the damage has already been done. Dozens of patients who were irreparably harmed by Invokana are now filing lawsuits, alleging the drug maker, in a rush to market a new medication, failed to adequately research the potential risks and properly warn about the dangerous side effects.

Did Johnson & Johnson and Janssen Pharmaceuticals put profit over public safety?

As the FDA continues to monitor Invokana and other SGLT2 inhibitors, the controversial drugs continues to be aggressively marketed and sold at a rapid pace. Meanwhile, dozens of Invokana lawsuits have been filed across the country against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, alleging they may have known about these risks, but put profit over patient health.

Plaintiffs across the country claim that that corporate giants such as Johnson & Johnson and its subsidiary Janssen Pharmaceuticals know of the risks associated with Invokana, but continue to market the product at a rapid pace without warning consumers.

Is an Invokana lawsuit right for you?

McDonald Law Firm is currently investigating claims by individuals who have suffered severe injury after taking Invokana or other SGLT2. If you or a loved one suffered life-threatening side effects after taking what was supposed to be a new “miracle” drug, we encourage you to contact us today to find out how you can hold drug manufacturers responsible for jeopardizing your life and livelihood. You may be eligible for compensation for medical bills, lost wages, pain and suffering, among other things.

Free, No-Obligation Case Review

If you or a loved one took Invokana and suffered severe or permanent injury after taking Invokana or other SGLT2 drugs, you may have grounds for a Invokana lawsuit to seek compensation for medical bills, injuries and emotional trauma. Contact us today at 877-803-2897 for a free, confidential case review to assess your situation and explore your legal options.

Did you or a loved one experience kidney failure or ketoacidosis after taking Invokana or other SGLT2 drug? 877-568-8304

Do you need an Invokana Lawyer?

Dealing with health problems caused by a dangerous drug can be expensive and exhausting. Medical bills and lost wages only add to the stress and frustration of recovering from a serious injury. Sometimes filing a lawsuit is the only way to reduce financial strain and help alleviate emotional pain and suffering.

While our Invokana lawyers can’t undo the damage that has already been done, we will do everything in our power to hold drug manufacturers responsible for putting profit over patient safety.

We have the experience to battle the largest manufacturers.

McDonald Law Firm has taken on some of the world’s largest drug and medical device manufacturers. Our lawyers have tried more than 200 cases to jury verdict and have successfully represented thousands of clients who have suffered due to defective medical devices and dangerous drugs, including hip implants, transvaginal mesh, silicone gel breast implants, Fen/phen, Baycol and Vioxx.

We don’t get paid unless you win.

The last thing you need to worry about is how to pay for a lawyer when you are juggling medical bills, time off work, etc. We’ll handle your Invokana lawsuit on a contingency basis, which means there are never any out-of-pocket fees or expenses. We only get paid if we win compensation for you ― either through settlement or a trial.

We’ll fight for you.

Drug companies have a duty to adequately research their medications and warn the public of potential dangers. Manufacturers who rush to get unsafe drugs on pharmacy shelves and put profit over patient protection could face legal liability. McDonald Law Firm is committed to holding the responsible parties accountable for your pain, suffering, unexpected medical expenses and other losses. If you or a loved one were hospitalized or suffered severe or permanent injury after taking this questionable drug, we may be able to help.

Let’s talk.

Call: 877-803-2897
Text: 817-203-0260

  • This field is for validation purposes and should be left unchanged.
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