The diabetes drugs Invokana and Invokamet may increase a patient’s risk of toe amputations, according to the FDA. Patients should seek medical attention immediately for symptoms like pain or tenderness, sores or ulcers, or infections in their legs or feet
Need a Texas Toe Amputation 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 had an amputation after taking Invokana, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
FDA ‘Black Box’ Warning: Invokana Doubles Amputation Risk
In May 2017, the FDA ordered drug-makers to add a ‘Black Box’ warning to the label on Invokana about the risk of toe, foot, and leg amputations. The most common amputations were in the toe and middle foot, but amputations of the leg below and above the knee were also reported. Some patients needed multiple amputations, or they had both legs amputated.
FDA Investigates Invokana Amputation Risk
In May 2016, the FDA issued a Safety Communication to warn about a study linking Invokana with a doubled risk of toe amputations. The FDA was concerned about preliminary data from the CANVAS clinical trial, an ongoing study investigating outcomes for patients on Invokana or a placebo. After one year, about 7 in 1,000 patients on Invokana (100-mg) required an amputation, compared to 3 in 1,000 patients on a placebo. Click here to read more.
What is the problem?
Invokana lowers blood-sugar levels by increasing the amount of sugar in urine. Patients can urinate excessively and become dehydrated, which decreases the amount of blood in the body and causes poor circulation in the toes. This increases the risk of foot problems that require amputation.
Diabetes and Toe Amputations
People with diabetes can develop serious foot problems. About 15% of all diabetics develop ulcers, and 25% of these lead to amputations. In 2010, about 73,000 adults with diabetes had a leg or foot amputation.
Diabetes harms the feet in a number of ways. It reduces blood-flow to the toes, which makes it harder to heal from injuries. Diabetes also causes nerve damage that makes it hard to feel when the feet are injured.
Amputation of the Toes
Toes are amputated to treat infections and remove dead tissue caused by gangrene. The procedure usually takes about 20-60 minutes. In many cases, patients go home from the hospital or within a couple days.
What to Expect
Before the surgery, patients may undergo an X-ray and bone scans to see if the bone is infected. Patients will be given anesthesia, intravenous (IV) antibiotics, and have the foot sterilized.
The surgeon will make an incision in the skin around the toes, cauterize blood vessels to stop bleeding, and remove bones. The end of the bone will be smoothed. The remaining skin is pulled over the opening and stitched closed.
Amputation and Infections
The risk of complications increases for patients who have active infections. In some cases, the skin is left open and packed with a moist dressing and a tube to drain fluids. The wound is closed when the infection is under control.
Patients must be vigilant for symptoms of an infection, such as red streaks leading from the incision, increasing pain, fever, body chills, redness, swelling, warmth, excessive bleeding, pus draining from the incision, fatigue, decreased sensation, numbness, nausea or vomiting, and new or worsening symptoms.
- Stump pain
- Hematoma (fluid collection)
- Failure to heal
- Amputation of more areas of the foot, toes, or leg
- Nerve damage
- Limp or trouble walking
Pain from a toe amputation usually improves within a week, and stitches can be removed about 10 days after surgery. You may need to wear a cast or special shoes for up to a month. It is normal to experience periodic “phantom pain” where your toe used to be.
It is a good idea to walk every day if you can. Start with just a short walk and increase the amount bit by bit. This helps improve blood-flow and prevent blood clots. Most patients will need to take a few weeks off from work to recover.
Need a Toe Amputation 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 toe amputation lawyers for a free lawsuit review.