INVOKANA USE MAY LEAD TO FOOT AND LEG AMPUTATIONS
On May 16, the Food and Drug Administration (FDA) issued a new warning about the diabetes drug Invokana. Now, the FDA “has concluded” based on tests that the drug presents an increased risk of foot and leg amputations. Specifically, the FDA safety alert says:
Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
In addition to the FDA public announcement on its website, news organizations are beginning to report the potential dangers of this drug. According to a new Reuters article titled FDA Warns of Foot, Leg Amputations with J&J Diabetes Drug:
Johnson & Johnson is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday.
Final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website.
The warnings include a boxed warning, reserved for the most serious possible adverse events, the FDA said.
This is a very serious new risk (in addition to the previously known serious risks). Although the FDA warning is new, we discussed serious questions about the risk of amputation injuries a year ago on this blog. In a May 23, 2016 post we asked, “How Dangerous Is Invokana?” In our May 2016 post, we stated:
Now, we see serious questions about an increase in lower limb amputations among patients using Invokana. To be fair to the drug’s maker Johnson & Johnson, these newest concerns are only preliminary. That is, more testing is needed before researchers can clearly link any increased risk of amputations.
A QUICK REVIEW OF INVOKANA DEVELOPMENTS
We have followed Invokana and its impact on Alabama patients closely. We long ago published an initial report about the drug on the Hot Topics section of our law firm website. Invokana (canagliflozin) is marketed to treat Type 2 diabetes. The drug is in a relatively new class of medications called sodium-glucose cotransporter 2 (SGLT2) inhibitors. The drugs Farxiga, Jardiance, Glyxambi, and Xigduo XR are also in this class of medications. These drugs alter kidney function to stop reabsorption of glucose into the blood stream. The FDA approved Invokana in 2013. Since approval, the drug has become a huge blockbuster for its maker Johnson & Johnson.
In addition to its huge sales and profits, the drug has also raised serious (and growing) health concerns. Very serious personal injury concerns. Diabetic Ketoacidosis. Kidney Injury and Damage. Bone Fractures. Foot and Leg Amputations. In addition to our initial Hot Topics report, we have written a number of prior posts about Invokana. Here is a list of prior articles published on the Blackwell Law Firm blog:
INOVKANA INJURY LAWSUITS ARE MOVING FORWARD
As more and more patients experience these serious problems, the number of Invokana injury lawsuits continues to climb. The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated the cases in Federal Court for pre-trial purposes. Judge Brian Martinotti in the U.S. District Court for the District of New Jersey has been assigned to oversee the lawsuits. Judge Martinotti has been active in moving the claims forward by appointing attorneys to leadership roles on behalf of injured plaintiffs. In a May 1 Case Management Order, Judge Martinotti also outlined his process for selecting “bellwether” cases for early trial.
If you have questions about Invokana, the Blackwell Law Firm is happy to provide additional information. Consultations are always free and confidential. We also welcome readers to our blog and articles. We follow developments closely and periodically publish new articles. Many of these articles discuss developments involving dangerous and defective drugs.