Johnson & Johnson’s, the drug manufacturer of diabetes drugs Invokana, Invokamet, and Invokamet XR, recently submitted a supplemental new drug application (sNDA) to the FDA to request expansion of the labels for these drugs.
If granted, the new label would include a cardiovascular indication concerning the reduction of risk of cardiovascular events in type 2 diabetes patients who have established CV disease or are at risk for CV disease.
The results of several recent studies on Invokana, called CANVAS and CANVAS-R, served as the catalysts for J&J’s request. These studies showed that patients who used Invokana / Invokamet / Invokamet XR–compared to those taking a placebo–were less likely to experience the following major cardiovascular events (MACE):
- Cardiovascular death
- Nonfatal myocardial infarctions (MI) / Heart attacks
However, these studies also brought to light a serious side effect of Invokana that has recently gained more attention in the medical literature.
In July of this year, the risk of amputations–particularly of the lower limbs–was included in a black box warning on the drug label for Invokana, Invokamet, and Invokamet XR. Black box warnings are the highest level of required warning for drugs manufactured and sold in the U.S., which illustrates just how severe this potential side effect is.
To read more about this increased warning, see my latest article on the topic, “Could Invokana have been the cause of my lower-limb amputation?”
Going forward, it will be interesting to see whether the cardiovascular benefits of Invokana, Invokamet, and Invokamet XR will make up for any decrease in prescriptions due to the serious amputation side effects of these drugs.
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for those who have undergone amputations of the lower limbs while using Invokana or other type 2 diabetes drugs. We encourage you to complete a free case evaluation, and visit our website for more information on these drugs and their potential side effects.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Drug Injury Watch: Side Effects News & Reports
Drug Injury Law: Medical & Legal Information
Previous articles on this topic:
- Could Invokana have been the cause of my lower-limb amputation?
- Can SGLT-2 Inhibitor Diabetes Drugs Increase Your Risk of Stroke?
- Invokana Shown to Have Heart Benefits, but Elevated Amputation Risks
- Risk of Lower Limb Amputations Doubled with Invokana and Invokamet Use
- All SGLT2 Inhibitors Now Investigated for Increased Risk of Amputation
- Are Invokana & Invokamet Linked to Increased Risk of Toe Amputations?