- The Food and Drug Administration on Tuesday warned of the risk of acute kidney injury from use of Johnson and Johnson's Invokana and AstraZeneca's Farxiga, both treatments for type 2 diabetes.
- Over 100 confirmable reports of acute kidney injury associated with use of the drugs were reported to the FDA between March 2013 and October 2015, according to the warning. About half of these cases occurred within one month following initiation of treatment, and most patients improved after halting use of the drugs.
- Labels for the two drugs will now include revised warnings on this risk, as well as new recommendations for care providers.
Both Invokana and Farxiga are SGLT-2 inhibitors, which cause the kidney to remove sugar from the body through urine.
Since their respective launches, the drugs have become important sources of revenue for the two drug companies. Invokana, approved in March 2013, pulled in $1.31 billion in sales last year, although growth slowed in the first quarter of 2016. Nearly all of the drug's sales occur in the U.S.
Farxiga, on the other hand, earned $492 million in 2015 but saw rapid growth of 119% compared to a year prior. AstraZeneca attributed the higher revenue to expanded patient access and greater promotional activity. A cardiovascular outcomes trial studying Farxiga is currently underway, with interim data expected in 2017.
Ever since Eli Lilly's and Boehringer Ingelheim's Jardiance demonstrated a cardiovascular benefit, other companies have rushed to study their drug's effect on heart risk. Although Jardiance is also an SGLT-2 inhibitor, it was not included in the FDA's warning.
The FDA's alert also covered the related drugs Invokamet (Johnson & Johnson) and Xigduo XR (AstraZeneca). Invokamet combines the active ingredient in Invokana with the diabetes medicine metformin.
Patients are advised to seek medical attention if they experience symptoms of kidney injury, such as decreased urine or swelling in the legs or feet. Healthcare professionals should assess kidney function prior to starting patients on the drugs, and monitor thereafter, the FDA recommended.
The FDA had previously issued a separate warning about an increased risk of leg and foot amputations in patients treated with Invokana during a clinical trial. However, no direct link between Invokana and increased risk of amputation has been established yet.