FDA Orders Johnson & Johnson To Add New Warning To Invokana Packaging
Last week, the U.S. Food and Drug Administration (FDA) released a drug safety communication calling for a new black box warning on the labels for type 2 diabetes drugs Invokana, Invokamet and Invokamet XR. Black box warnings are the most serious warnings the FDA adds to drug labels.
The new warning says that canagliflozin, the generic name for Invokana and other similar type 2 diabetes drugs, may increase the chances that patients will need to have a leg or foot amputated.
Clinical Trials Show Increased Risk Of Amputations
The FDA is requiring the new warning because of two clinical trials showing that leg and foot amputations happened almost twice as often in patients who took canagliflozin compared to patients taking a placebo, according to the drug safety communication.
Researchers discovered that 5.9 of every 1,000 patients who took canagliflozin had to have amputations, compared to 2.8 of every 1,000 patients who took a placebo.
The number of patients who needed amputations increased after taking the medication for one year. According to the study, 7.5 of every 1,000 patients needed amputations, compared to 4.2 of every 1,000 patients who took a placebo.
The most frequent amputations were of the toe and middle of the foot. Amputations above and below the knee have also occurred. Some patients had more than one amputation, including amputations of both lower limbs.
The clinical trials were conducted by Johnson & Johnson (J&J), which manufactures Invokana, Invokamet and Invokamet XR. Company officials were hoping the studies would show that these drugs were safe.
The FDA drug safety communication urges doctors and patients to report canagliflozin side effects to the FDA's MedWatch program.
Other Warnings About Invikana
This is not the first warning the FDA has issued about canagliflozin. In June 2016, the FDA released a drug safety communication warning about the risk of acute kidney injury from this medication.
The warning advised patients to seek immediate medical attention if they experience any symptoms of a kidney injury, including decreased urine and swelling in the feet or legs.
The communication noted that, between March 2013 and October 2015, the FDA had received 101 reports of acute kidney injuries from patients taking this medication.
If you had to have an amputation or dealt with other health problems after taking Invokana, you may be able to file an Invokana lawsuit to recover compensation for medical expenses and other damages.
The experienced
defective drug attorneys at O'Connor, Acciani & Levy can help build a strong case that increases your chances of a favorable outcome.
