Invokana Linked to Potential Limb Amputation Risks
Did you take Invokana? Reports show the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from Johnson & Johnson regarding the risk of lower-limb amputations. The drug has already been under scrutiny for safety issues in the United States. If a correlation is discovered that links Invokana to lower-limb amputations, doctors should reevaluate the way in which the medication is prescribed.
Learn more about Invokana lawsuits by calling (713) 621-7944.
What is Invokana?
Invokana (canagliflozin) is a type 2 diabetes drug used to help individuals control high blood sugar. It was first introduced by Johnson & Johnson subsidiary Janssen Pharmaceuticals in 2014 as a new class of diabetes drugs. Without control, people with high blood sugar risk kidney damage, nerve issues, blindness, sexual function problems, and limb loss. Common side effects include the following:
- Dry mouth
- Frequent urination
More serious side effects have included bladder infection, yeast infection, high potassium levels in the blood, or kidney problems. Invokana has also been linked to the potential risk of heart attacks. Now, there have been FDA warnings for patients to be aware of soreness, new pain, infections, or ulcers in the feet or legs and to notify their doctors immediately. The FDA has stated that — based on ongoing clinical trial data — individuals treated with Invokana are twice as likely to require: toe, foot, or leg amputations than those taking a placebo. They urge healthcare providers to report adverse events of amputation while they continue to evaluate the safety of the drug.
On May 18, 2016, the Food and Drug Administration issued a drug safety communication informing the public and those in the medical field of the issues involving Invokana and the connection with leg, foot, and toe amputations. The agency is investigating new safety issues regarding the drug.
Studies Showing Associated Risks of Lower-Limb Amputation
According to a safety review by EMA, 7 in every 1,000 people who take Invokana 100-mg for one year experience a toe amputation. This number is in comparison to the 5 in 1,000 taking the 300-mg dose and the 3 in 1,000 taking a placebo. The studies are based on results from an ongoing clinical trial called Canagliflozin Cardiovascular Assessment Study (CANVAS).
The study is analyzing roughly 2,000 patients with type 2 diabetes and the groups taking Invokana are showing a higher rate of amputation in the lower limbs.
Did you have a lower limb amputated after taking Invokana? Call (713) 621-7944!
If you have taken Invokana and had a lower limb amputated, we encourage you to discuss your possible case with us. Our Invokana attorneys at Fleming | Nolen | Jez, L.L.P. have more than 170 years of combined experience. We can take the time to analyze your potential claim and explain the next steps in the process.
Call (713) 621-7944 today to schedule your free consultation.