Invokana Linked to Deadly Complications as Number of Lawsuits Continues to Mount

Janssen Pharmaceuticals, a division of Johnson and Johnson, is facing hundreds of lawsuits by plaintiffs who allege that the company knowingly pushed a diabetes drug that is known to be dangerous to market.

Canagliflozin, a drug that was developed to lower blood sugar in patients with Type-2 diabetes, has been facing an uphill battle almost since it was first introduced to the U.S. Food and Drug Administration in 2013 as the brand-name drug Invokana. At that time, the FDA directed an advisory committee to examine possible cardiovascular, bone risk, and kidney impairment concerns. Three months later, however, the administration approved the drug despite it’s earlier concerns.

Consumer Advocacy Group Asserts Janssen Marketed Invokana As A Weight Loss Drug

Two years later, in April 2015, the drug made headlines again when a consumer advocacy group, Public Citizen, called out Janssen for allegedly marketing Invokana as a weight-loss drug.

“The advertisements … clearly convey the false perception to patients and doctors that the drugs have been deemed safe and effective for weight loss,” Public Citizen was quoted by Law360. “By inflating the drugs’ perceived benefits, the advertisements dangerously skew the risk-benefit calculations made by physicians and patients in deciding whether to initiate or continue these therapies.”

Janssen denied the claims, saying that they had received FDA approval because the administration had approved the statements about weight loss on the drug’s label as a secondary effect of taking the drug.

“These secondary effects can be important, given that approximately 90 percent of people with type 2 diabetes struggle with their weight, and that many current medications for the condition are associated with weight gain,” Janssen said.

Cardiovascular, Bone, and Kidney Concerns Resurface

One month later, in May 2015, the initial concerns that the FDA had over the drug back in 2013 resurfaced when they linked Invokana to serious blood problems in a safety alert. Since the drug’s release in March of 2013 until May of 2015, the FDA received 73 reports from patients of development of diabetic ketoacidosis. This disorder involves increased acids in the blood that can lead to comas or death. At the time, Invokana was nearing $266 million in sales in the first quarter of 2015.

By September 2015, the FDA renewed its earlier warnings that the drug also causes decreased bone density and increased bone fractures, even noting that it only took 12 weeks of use of the drug to see bone fracturing. They advised healthcare professionals to “consider factors that contribute to fracture risk prior to starting patients on canagliflozin (Invokana).”

By this time, the drug had been prescribed more than 5 million times, Janssen told Law360.

“We have worked with the U.S. Food and Drug Administration to update our label to include new data on the low annual incidence of bone fracture and risk of decreased bone mineral density,” a spokeswoman told them. “We remain confident in the overall safety profile of Invokana and will continue working with the FDA on their assessment of this issue.”

Just three months later, in December 2015, the FDA once again required the company to update its labels after it had found increased cases regarding diabetic ketoacidosis from the drug as well as acute urinary tract infections – a few of which lead to  treatments for kidney failure.

Lawsuits Against Johnson and Johnson

Then the cases started rolling in. On December 10, 2015, one Arthur Portnof brought the first Invokana related lawsuit against Johnson and Johnson, the parent company of Janssen Pharmaceuticals. Mr. Portnoff claimed to have been taking the drug since November 2014 and to have developed diabetic ketoacidosis as a result.

“Defendants withheld material information from the FDA and misrepresented material information regarding the risks and benefits of Invokana in its communications with the FDA,” Portnoff said in his complaint.

He accused Janssen Pharmaceuticals and Johnson and Johnson of strict liability for a “design defect and failure to warn claims” as well as a breach of warranty guaranteeing the drug’s safety.

Janssen fired back by trying to have the case dismissed on legal grounds and argued against Portnoff’s statements.

“To the extent the plaintiff alleges that the prescribing information for Invokana contained such a warranty, he is simply mistaken,” the company said. “The prescribing information — which the court may judicially notice — does not contain an unqualified statement that Invokana is ‘safe and effective.’”

Use of Invokana Linked to 100% Greater Risk of Amputation

By May 2016, the FDA was again warning patients who took Invokana that they were at risk. This time, they had found that patients who used the drug were roughly twice as likely to undergo amputations as patients who had taken a placebo.

“The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet),” they said in a statement at the time.

The clinical trial had been an independent study lasting nearly four-and-a-half years. It had found that 5 out of 1,000 patients taking a daily dose of 300 mg required amputation of toes, feet or legs.

The FDA did note that another trial being run at the time which covered only a 9-month span hadn’t found the same dangers.

Number of Lawsuits Against Janssen and Johnson & Johnson Continues to Increase

By September 2016, Invokana lawsuits against Janssen had neared 90 cases. By November, that number had increased to over 100 liability lawsuits filed in Philadelphia alone, and the drug’s sales were reportedly exceeding $1 billion annually.

In their lawsuit, plaintiffs alleged that Janssen Pharmaceuticals knew about the drug’s dangers and didn’t sufficiently warn the public.

“To the contrary, Defendants conducted nationwide sales and marketing campaigns to promote the sale of Invokana and willfully deceived consumers, health care professionals, the medical community, and the general public as to the health risks and consequences of the use of the Invokana,” the brief states.

In an article by Law360, Kaitlin Meiser, a spokeswoman for Janssen Pharmaceuticals, said that Invokana was the leading drug of its type in the US, with more than 9 million prescriptions to date.

Five months later, in May 2017, the FDA confirmed its earlier findings that use of the drug did, in fact, increase the risk of amputations with some patients requiring more than one amputation or amputation of both limbs. They ordered forced boxed warnings that were effective beginning in July of 2017.

“Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet,” they said in the statement.

At present, hundreds of cases are still being argued related to Invokana.

With the prescription still on the market, it is imperative that patients pay close attention to symptoms they may experience while taking this medication.

Some of the symptoms and side effects to watch for include:

• Increased heart rate

• Chest pain

• Changes in urination

• Sleepiness or fatigue

• Difficulty breathing

• Weakness in your body

• Hyperventilation

• Nausea or vomiting

• Severe abdominal pain

All patients who are taking Invokana need to watch for signs of heart or kidney problems and should work closely with their doctor to closely monitor any issues that may arise.