While Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, were the first to bring an SGLT-2 inhibitor drug—Invokana—to market in 2013, other companies were not far behind. AstraZeneca and Bristol Myers Squibb Company brought the SGLT-2 inhibitor drug Farxiga out in January, of 2014. Soon after came Boehringer Ingelheim’s Jardiance, Janssen’s Invokamet, AstraZeneca’s Xigduo XR, and Eli Lily’s Glyxambi.
Despite the fact that the FDA approved Invokana as well as the other five SGLT-2 drugs, the vote for Invokana was 10 to 5. There were those on the panel who had concerns regarding the safety and long-term effects of SGLT-2 inhibitors. The panel required that J & J complete an additional five studies post-market, including a cardiovascular study, a bone safety study, two pediatric studies and a program which monitored malignancies, pancreatitis, hypersensitive reactions, liver abnormalities and pregnancy outcomes.
Little more than two years after the FDA approved Invokana, and even less time since the other five Type 2 diabetes drugs were approved, the agency issued a warning which stated a significant number of aftermarket reports had been received linking SGLT-2 inhibitors to ketoacidosis. Ketoacidosis is an extremely serious, potentially fatal condition in which acids build up in the bloodstream. This can happen when blood sugar levels are too high for too long a time. A body with insufficient levels of insulin will use fat for energy rather than sugar.
When this fat is burned, it creates acids called ketones, and when an excess of ketones built up in the blood, the chemical balance of the blood is thrown off and the entire body is disrupted. It is rare for those with Type 2 diabetes to suffer ketoacidosis, however cases have been noted among patients taking Invokana or a similar SGLT-2 inhibitor drug. This class of drugs may promote ketoacidosis due to the way the kidneys are affected. Symptoms of ketoacidosis include throwing up for more than two hours, being tired, confused or “woozy,” having a difficult time breathing, feeling queasy, being unusually fatigued or having breath which smells “fruity.”
Is Farxiga Worse Than Invokana?
Farxiga (sold under the brand name Forxiga outside the United States), appears to have all the same adverse side effects as Invokana, however Farxiga has also been found to increase LDL cholesterol (the “bad” cholesterol). Farxiga is also sold as a SGLT-2 inhibitor combined with metformin under the brand name Xigduo. There were more cases of bladder cancer among those taking Farxiga than in the control group which were given a placebo. The manufacturer of Farxiga, AstraZeneca, believes the numbers in the study were too small to determine a definitive bladder cancer risk.
An early 2014 Huffington Post article deemed Farxiga the worst drug of 2014, calling it a “new diabetes medication that doesn’t noticeably improve health but may, in fact, be linked to cancer.” According to the FDA, the most common side effects of Farxiga are urinary tract infections and genital fungal infections, however for patients with moderate or severe kidney damage, the drug could cause further damage to the kidneys or even total renal failure. Just as frightening, in studies done for the FDA, patients taking Farxiga were five times more likely to contract bladder cancer than those taking an older diabetes drug.
Johnson & Johnson and Janssen’s Failure to Warn
Like Farxiga, Invokana has an equally shaky track record as far as potential consumer harm. During the first year following Invokana’s release, more than 450 adverse event reports were filed with the FDA. Fifty-four of those reports were of kidney failure, another 54 for severe fluid imbalance, 11 cases of kidney stones, 50 cases of allergic reactions, 52 cases of abnormal weight loss and 50 cases of urinary tract infections. The Institute for Safe Medication Practices monitored and analyzed those FDA adverse event reports.
The Institute noted the high number of renal failure cases associated with Invokana—a fact which was also known by Janssen and Johnson & Johnson. The accepted “rule of thumb” is that only about one percent of all adverse events associated with a drug or medical device are actually reported to the FDA. If this holds true with Invokana adverse event reports, then as many as 5,400 cases of renal failure could potentially be associated with the drug. Like many other huge drug companies, perhaps Johnson & Johnson and Janssen simply chose not to put patient safety over financial gain.