The FDA is investigating a connection between diabetes drugs belonging to the Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors class of drugs and the following side effects:
- Diabetic Ketoacidosis (DKA)
- Ketoacidosis
- Ketosis
- Acute Kidney Injury
- Kidney Failure / Renal Failure
- Kidney Damage
- Pyelonephritis (kidney infection)
- Urosepsis (blood infection)
- Urinary Tract Infection (UTI)
- Leg Amputation
- Foot or Toe(s) Amputation
Some of the popular drugs in this SGLT2 inhibitors class are Invokana, Farxiga, Jardiance, Invokamet, Xigduo, Glyxambi, Synjardy, and Qtern.
While DKA seems to be the most frequently discussed side effect of these drugs, discussion of amputations relating to the lower limbs seems to be gaining popularity in the medical literature.
At least one lawsuit has been filed against the drug manufacturer of Invokana concerning a patient who had a lower limb amputation after using the drug.
Additionally, the drug label for Invokana has recently been updated to include the strictest possible warning for amputations:
INVOKANA may increase your risk of lower limb amputations. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body.
One important step in determining whether the SGLT2 inhibitor could have caused the amputation is ruling out other risk factors for amputations.
The Invokana Medication Guide (page 45 of the PDF), revised in July 2017, provides the following information concerning possible risk factors:
You may be at a higher risk of lower limb amputation if you:
- have a history of amputation
- have heart disease or are at risk for heart disease
- have had blocked or narrowed blood vessels, usually in your leg
- have damage to the nerves (neuropathy) in your leg
- have had diabetic foot ulcers or sores
On a related note, the study titled “SGTL2 inhibitors and amputations in the US FDA Adverse Event Reporting System,” provides the following information regarding adverse effects that were also observed in study participants:
Based on indications…concomitant adverse events included wound, necrosis, gangrene, or ischaemia in 14 cases, and osteomyelitis or other infections in 15 cases.
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for who have developed any of the medical conditions listed at the beginning of this article after using an SGLT2 inhibitor. We encourage you to complete a free case evaluation, and visit our website for more information.
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