If your leg, foot or toe was amputated after you took Invokana or Invokamet for type 2 diabetes, you may have the right to sue the maker of these drugs, Janssen Pharmaceuticals, Inc., a Johnson & Johnson company.
On May 16, 2017, the FDA concluded that the Type 2 diabetes medication Canagliflozin (Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations. The FDA will now require the most prominent black box warning to be added to the Canagliflozin drug labels. This new warning came at the conclusion of two large clinical trials, one of which showed that leg and foot amputations occurred about twice as often in patients treated with Canagliflozin versus a placebo.
Two clinical trials found an approximate 2-fold increased risk of lower limb amputations associated with a medicine called canagliflozin, sold by Janssen Pharmaceuticals under the brand names Invokana® and Invokamet®, both registered trade names.
These were large, randomized, placebo-controlled trials evaluating patients with type 2 diabetes who had either established heart disease or were at risk for it. These clinical trials were named CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus).
The combined amputation data is as follows:
- amputations of the toe and mid-foot (99 out of 140 patients with amputations receiving canagliflozin in the two trials);”list-style: none”>
- amputations involving the leg, below and above the knee (41 out of 140 patients with amputations receiving canagliflozin in the two trials).
Some patients had more than one amputation, including a few involving more than one limb.
The most common medical events leading to amputation included lower limb infections, gangrene, diabetic foot ulcers, and ischemia. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.
The sponsor of both studies was Janssen Research & Development, LLC.
Plaintiff’s attorneys argue that if the manufacturer had properly warned, then doctors would have prescribed a medication other than Invokana for patients with type 2 diabetes, and certainly patients would have had their health monitored on a more frequent basis for potential medication complications.
- “In CANVAS, the risk of lower limb amputations was 5.9 amputations per 1,000 patients per year for canagliflozin compared to 2.8 amputations per 1,000 patients per year for placebo,” said the FDA.
- This study was started in December of 2009 and the primary completion date was February 22, 2017.
- “In CANVAS-R, the risk of lower limb amputations was 7.5 amputations per 1,000 patients per year for canagliflozin compared to 4.2 amputations per 1,000 patients per year for placebo. The risk of lower limb amputations was observed at both the 100 mg and 300 mg doses,” said the FDA.
- This study was started in January of 2014 and the primary completion date was February 21, 2017.
Invokana, Invokamet, Invokamet XR and Canagliflozin are prescription medications used in combination with diet and exercise to lower blood sugar and improve glycemic control in adults with type 2 diabetes.
If you or a loved one has suffered an amputation or other serious injuries as a result of taking Invokana, Invokamet, or Invokamet XR, you may be entitled to compensation through an Invokana lawsuit.
The attorneys of Reyes Browne Reilley may be able to help. We understand manufacturers are responsible for making sure their products are safe before releasing them on the market. It’s also their job to ensure doctors and patients are well aware of the risks before prescribing or taking their drugs.
At Reyes Browne Reilley, we are on top of the developments concerning Invokana, Invokamet and Invokamet XR and are happy to give you a free case consultation. Call today at (214) 526-7900.