The team of drug and device liability lawyers at Walkup Melodia is actively pursuing Invokana and Invokamet cases in California. Our investigation has revealed that a number of patients that received this drug suffered serious and potentially needless complications, including amputations of the leg, feet or toes.
If you or a loved one were taking Invokana or Invokamet and suffered these or other complications, please contact our attorneys at (415) 801-3435 today. Our record of multi-million dollar results is unmatched, and there is no cost or obligation to speak to an attorney.
What is Invokana?
Invokana and Invokamet are prescribed for patients with type 2 diabetes, to be taken along with diet and exercise. Type 2 is the most common form of diabetes, wherein the body causes blood glucose (sugar) levels to rise higher than normal. Moreover, type 2 diabetes patients often have difficulty creating and processing insulin.
Type 2 diabetes can result in major health problems such as stroke, nerve damage, vision loss and high blood pressure. Invokana and Invokamet is designed to lower a person’s blood sugar by causing the kidneys to process blood glucose through urine.
Also known as canagliflozin, Invokana was initially developed in 2012, and is manufactured by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson. In March 2013, the Food and Drug Administration (FDA) approved the sale of Invokana in the United States. The drug is designed as a class of subtype 2 sodium-glucose transport (SGLT-2) inhibitor. Whereas Invokana contains only the active ingredient (canagliflozin), Invokamet combines canagliflozin with metformin.
Potential Complications caused by Invokana and Invokamet
Because Invokana operates primarily through the kidneys, patients who take the drug may become dehydrated. This can cause compromised blood flow to the arms, legs and feet. In diabetic patients, limited blood flow can also result in extremely harmful results, including bacterial infection and amputation.
These complications are particularly dangerous for type 2 diabetics, who already live with a risk of foot problems because of high blood pressure and impaired circulation. As a result, any needless increase to that risk must be clearly identified disclosed to physicians and their patients.
In May 2016, the FDA issued a warning about “interim safety results from ongoing clinical trials that found an increase in leg and foot amputations, mostly affecting the toes,” in patients treated with Invokana and Invokamet. The warning was issued after data generated during the course of a large clinical trial (known as the CANVAS trial), or safety study compared to a placebo (an inactive treatment).
The clinical studies of Invokana and Invokamet followed patients for over five years. By the time they were completed, the results made clear that patients who received the drug required amputation about twice as often as those who received a placebo.
According to the FDA, the amputations varied in location and severity:
Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.
FDA Black Box Warning Added
In May 2017, as a result of these findings, the FDA required Janssen Pharmaceuticals and Johnson & Johnson to issue “Black Box” warnings. Black box warnings are the most significant category of labeling change ordered by the federal agency. Issued in May 2017, the warning includes the following language:
Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
The agency further urged patients to notify their doctors right away if they develop any new pain, sores, ulcers or infections to the legs and feet. Patients were also cautioned to speak to their physicians about any questions they have. Finally patients are warned not to stop taking their medication until they’ve spoken to a physician.
The FDA also instructed that before prescribing Invokana and Invokamet, physicians should be mindful of factors that may patients more likely to have amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Doctors were also told to monitor signs and symptoms of foot complications, and to stop the medications if any such symptoms occur.
How an Invokana Attorney Can Help
If you or a loved one have suffered any of the serious side affects associated with Invokana or Invokamet, you must act quickly. An experienced legal team will begin investigating your case right away and ensure that your rights are protected. The trial lawyers at Walkup Melodia have a strong and accomplished record in pursuing cases against several drug and device companies, including Johnson & Johnson. We spare no effort to secure the best possible results for our clients and maintain our reputation for honesty and diligence. We are currently investigating and prosecuting cases on behalf of California residents who underwent amputation following the use of Invokana and Invokamet.
If you or someone you know has such a potential claim, please contact us for a free case evaluation at (415) 801-3435.