An Invokana amputation warning will be added to the Invokana label. On May 16, 2017, the U.S. FDA confirmed that this black-box warning must be included in the Invokana label. The revised label will state that Invokana raises the risk of people needing to have their legs or feet amputated. A black box warning is the strongest label warning in the FDA’s rusty tool box.(It habitually comes too late for many. How do dangerous drugs like this ever get FDA approval in the first place? Could the agency be compromised by the drug industry with which it works so closely?)Related: Invokana Lawsuit
The FDA first sent out an alert May 18, 2016, which said patients in Invokana clinical trials were twice as likely to need amputations as those on a placebo. On May 16, 2017, the FDA issued the final results from those two clinical trials. Those dire results triggered the new warning label.
Invokana / Invokamet / Canagliflozin
Invokana, Invokamet and Invokamet XR are brand names for canagliflozin, which is used to treat Type 2 diabetes. Janssen Pharmaceuticals, a division of baby-powder-beleaguered Johnson & Johnson, makes and markets Invokana (Canagliflozin).
Invokana Clinical Trials show Double Risk of Amputations
In the first clinical trial – CANVAS – 5.9 of 1,000 patients on the drug needed an amputation in a year, vs. the placebo totals of 2.8 of 1,000. In the second trial – CANVAS-R – 7.5 of 1,000 patients needed amputation compared with 4.2 of 1,000 on the placebo.
Most of the amputations were of the foot or a toe, said FDA, while others lost legs. Some patients needed more than one amputation.
FDA Safety Communication
The FDA said in a safety communication: “Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your healthcare professional if you have questions or concerns.”
FDA also cautioned Invokana users not to stop taking the medication without first speaking with a “health care professional.”
Janssen Speaks
A Janssen spokesmodel, William Foster, said, “At Janssen, patient safety is our highest priority. (We) are working with FDA to include (this) in the prescribing information for canagliflozin and look forward to the presentation of the full CANVAS Program results at the American Diabetes Association Scientific Sessions in June.”
Invokana Amputation Warning
Invokana (canagliflozin) was approved despite concerns about cardiovascular health and bone safety. The FDA has since updated the drug’s labels to reflect risks of bone fractures, blood disorders, and urinary tract infections.
SGLT2 Inhibitors
Other drug makers and drugs in Invokana’s class of sodium-glucose cotransporter 2 (or SGLT2) inhibitors include:
• AstraZeneca PLC – Farxiga and Xigduo XR
• Boehringer Ingelheim – GmbH
• Eli Lilly and Co. – Jardiance and Glyxambi
RELATED
- Invokana Lawsuit Attorney
- Invokana Warnings FDA Strengthened
- FDA – Invokana’s Tepid Approval
by Matthews & Associates
