Despite a multitude of warnings for a drug taken for treatment of type 2 diabetes, the U.S. Food and Drug Administration (FDA) has expanded indications for Invokamet (canagliflozin and metformin). Invokamet along with Invokana (canagliflozin), carry warnings for adverse reactions including an increased risk for lower limb amputations, kidney failure, diabetic ketoacidosis, and cardiovascular injuries.
Invokamet was initially approved by the FDA in 2014. Invokamet XR was given the FDA’s green light as an extended-release drug for the treatment of type 2 diabetes. “Invokamet XR offers the convenience of once-daily dosing and provides physicians needed flexibility for tailoring treatment to the needs of type 2 diabetes patients, especially those with higher A1c levels,” said John Anderson, M.D., with the Frist Clinic in Nashville, Tennessee, in a published statement on behalf of Invokamet XR manufacturer Janssen Pharmaceuticals.
The statement appeared in Formulary Watch in September 2016. “As with Invokamet, physicians can prescribe the XR formulation to adults when they are first diagnosed with type 2 diabetes or as additional therapy for people whose A1c levels are not well controlled with either agent alone,” said Dr. Anderson.
There are some similarities between the two diabetes medications such as the FDA warnings of fracture risk with both Invokana and Invokamet. The bone fracture risk includes metformin, which is part of the genetic makeup of Invokamet and Invokamet XR along with canagliflozin (Invokana). Both are comprised of a combination of canagliflozin and metformin.
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With Invokamet XR, there is a boxed warning issued by the manufacturer, Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, and the FDA, concerning lactic acidosis, a rare but serious complication that can occur due to metformin accumulation. Also, Invokamet XR should not be taken by patients with type 1 diabetes, or for the treatment of diabetic ketoacidosis.
The FDA, more recently issued a black box warning concerning Invokana and a higher risk for foot and leg amputation. A black box warning is the most serious level of warning to be placed on a label. This action was done in May 2017, and is in addition to existing concerns over the potential for kidney failure, diabetic ketoacidosis, and cardiovascular injuries. Numerous Invokana lawsuits allege these injuries. The most recent FDA-ordered black box warning, issued on May 16, only increases and deepens these concerns.
Together with the black box warning issued at the time of FDA approval for Invokamet XR extended release metformin/canagliflozin, the implication that the benefits linked to Invokana and Invokamet/Invokamet XR come at a particularly high price to the patient or plaintiff, in terms of adverse event potential.
As of September 2016, Invokana was reported to be the most-prescribed sodium co-transporter 2 (SGLT2) in its class, with more than nine million prescriptions written in the United States alone.
Bone Fracture Risk Data
Along with Invokamet and Invokamet XR, Invokana was tagged with bone fracture risk within two years of its initial approval by the FDA in 2013. The agency warned that Invokana could heighten bone fracture risk and decrease bone mineral density in type 2 diabetes patients.
When elderly patients were tested for changes to bone mineral density over two years in a post-marketing safety review, 714 people participated. The results revealed that patients starting the drug suffered bone fractures as early as 2 weeks into treatment. Canagliflozin appeared to have caused loss of bone mineral density at the hip and lower spine. The information gathered from the clinical trial confirmed fractures happened more often in patients with canagliflozin, particularly in post-menopausal women.
The FDA is authorized to approve and maintain medications provided benefits outweigh risks for the intended patients. In leaving Invokana and Invokamet/XR on the market, the FDA is implying that the SGLT2 medications are considered not unsafe and carry benefits to the patient that still outweigh the risks.
Patients and plaintiffs considering Invokana or Invokamet/metformin lawsuits alleging amputation, bone fracture, kidney, or cardiovascular injuries, may not agree with the FDA’s appraisal.
Legal Help Regarding Diabetes Medications’ Side Effects
If you or someone you know has been injured by Invokana or other diabetes medications, you may be eligible for valuable compensation. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).