The diabetes drug Invokana has been linked to a doubled increased risk of lower-limb amputations (especially toe amputations) in an ongoing clinical trial.
Need a Texas Invokana 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.
UPDATE: FDA Orders “Black Box” Warning for Amputation Risk
In May 2017, the FDA concluded that Invokana doubles a patient’s risk of needing a foot, toe, or leg amputation and ordered drug-makers to add a “Black Box” warning label about the risk. Amputations of the toe and middle foot are most common, but amputations of the leg below and above the knee also occurred. Some patients had multiple amputations, or both legs amputated.
What is the problem?
Invokana is a diabetes drug that has only been on the market since 2013, but already associated with a wide range of severe side effects.
It was the first drug to reduce blood-sugar by increasing urination. The problem is that many patients become dehydrated, which decreases blood-volume and causes circulation problems.
In people with diabetes, foot complications are extremely common and the #1 reason for hospitalization. Poor circulation in the feet means infections can spread rapidly and a leg or foot amputation may be necessary to prevent death.
FDA Investigates Invokana Amputation Risk
May 2016 — The FDA is investigating a new study linking Invokana with a doubled increased risk of lower-leg amputations in diabetic patients. Patients should notify their doctor right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.
The study involves 4,330 patients who are randomly assigned to take Invokana (100-mg or 300-mg daily doses) or a placebo. They have been tracked for an average of 4.5 years.
Researchers found that after one year, 7 out of 1,000 patients on 100-mg dose and 5 out of 1,000 on the 300-mg dose required a lower-limb amputation. In comparison, only 3 in 1,000 people on a placebo had an amputation.
The risk was seen in preliminary data from CANVAS, an ongoing clinical trial comparing the risk of cardiovascular disease in patients on Invokana vs. a placebo.
The European Medicines Agency (EMA) has also asked Janssen for more information and whether there should be any changes to the way Invokana is used, according to Medscape.
Diabetes and Foot Amputations
Foot complications are very common in people with diabetes. About 15% of all diabetics will develop a foot ulcer, which is an open sore that does not heal for several weeks or months. About 25% of people with a foot ulcer will need an amputation.
What Causes Diabetic Foot?
- Poor circulation: High blood-sugar causes blood vessels in the feet and legs to narrow and harden over time. This decreases circulation in the feet and makes it harder to fight infections or heal from minor injuries.
- Nerve damage: High blood-sugar also damages nerves (peripheral neuropathy), which reduces sensation in the feet. Patients can injure their feet and develop an ulcer without realizing it.
The toes, especially the big toe, help you move and balance. They need a steady supply of blood with oxygen and nutrients. If the toes do not get enough blood, they start to die. Symptoms may include:
- Chronic pain
- Skin changes colors or turns blue or black
- Wounds do not heal
- Infections that spread quickly
Amputating dying toes can save your life. Even a minor cut can develop into a serious infection that spreads to the rest of the body. These complications are very painful and can cause death.
Toe amputation surgery usually takes less than an hour and most patients go home from the hospital the same day. In some cases, only a part of the toe will need to be removed. The goal of amputation is removing dead tissue, relieving pain, and preventing the loss of other toes.
Need an Invokana 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 Invokana lawyers for a free lawsuit review.