One of the most common side effects of Invokamet is dehydration, which can cause poor circulation in the feet. The FDA has recently warned about studies linking Invokamet with a doubled increased risk of lower-limb amputations, mostly toe amputations.
Need a Texas Invokamet Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one needed an amputation, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is the problem?
Invokamet treats diabetes by increasing the amount of sugar that is removed from the body in urine. Too much urination can cause dehydration, which decreases circulation in the feet and increases the risk of foot disease, infections, ulcers, and amputations.
FDA Investigates Invokamet Amputation Risk
A doubled increased risk of lower-limb amputations, primarily of the toes, has been observed in an ongoing clinical trial with Invokamet. The FDA has issued a Safety Communication and will investigate the risk. In the meantime, the agency recommends:
“Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”
Study Finds Invokamet May Double Risk of Amputations
The CANVAS clinical trial is an ongoing study investigating whether Invokamet decreases cardiovascular events for people with diabetes. It began in 2009 and enrolled 4,330 patients to take canagliflozin (100-mg or 300-mg per day) or a placebo.
Preliminary data from the CANVAS study suggests that canagliflozin more than doubles the risk of toe amputations. After the drug is used for at least one year, amputations occurred in:
- 7 out of 1,000 patients on 100-mg canagliflozin
- 5 out of 1,000 patients on 300-mg canagliflozin
- 3 out of 1,000 patients on a placebo
Dehydration May Increase Risk of Amputations
Janssen Pharmaceuticals warned doctors that “dehydration and volume depletion might play a role in the development” of lower-limb amputations from Invokamet. They asked doctors to monitor patients for symptoms of dehydration (loss of body water and salt). Diuretics could exacerbate the condition.
Diabetic Foot Disease
Foot disease is the most common reason why people with diabetes are hospitalized. Over time, high blood-sugar causes blood vessels to narrow and harden, which decreases circulation to the feet. Many people with diabetes also develop neuropathy (nerve damage), which makes it harder to feel when the feet are injured.
Symptoms of Diabetic Foot
When the feet are not getting enough blood, patients may experience:
- Cold skin
- Chronic pain
- Skin darkens
- Nerve damage
- Ulcers (sores that last for months)
- Poor healing
- Infections that spread rapidly
Toe amputations can stop painful ulcers and prevent infections from spreading to the rest of the body. About 15% of all diabetics will develop an ulcer at some point, and 25% of these patients require an amputation. The surgery is usually straight-forward, lasting less than an hour, and most patients go home the same day.
Need an Invokamet Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Invokamet lawyers for a free lawsuit review.