In addition to ketoacidosis (dangerous acidity levels in the blood), kidney damage and a host of other harmful and even fatal side effects, the diabetic drug Invokana (canagliflozin) is now being implicated in acute pancreatitis, a serious – and sometimes fatal – inflammation of the pancreas, the organ that produces insulin.
In recent months, the FDA has been receiving numerous reports of patients taking SGLT2 inhibitors developing this condition, which is characterized by severe pain, nausea, vomiting, elevated heartbeat and fever. About one out of every 10 patients who develop pancreatitis die from the condition.
Normally, acute pancreatitis is the result of gallstones or alcoholism. Last year, two case studies were published in Therapeutics and Case Management and Basic and Clinical Pharmacy. Both studies reported patients developing acute pancreatitis after taking Invokana for only a short period of time – in one case, only four days. In one of the studies, the authors wrote,
“Our case demonstrates very rare but serious side effect, acute pancreatitis in the use of canagliflozin…as the utility of canagliflozin expands, physicians must be aware of this potentially fatal adverse effect.”
SGLT (“Sodium-Glucose Transport Protein”) 2 inhibitors were initially hailed as a breakthrough treatment for Type 2 diabetes. Part of a class of prescription drugs known as gliflozins, these drugs prevent the kidneys from reabsorbing excess glucose. The result is that excess blood sugar is passed through the urine.
In addition to causing ketoacidosis, Invokana has been linked with urinary tract infections, yeast infections and hypoglycemia (low blood sugar). A warning about these side effects was issued by the FDA in May of 2015. Invokana has been the cause of action in numerous lawsuits, 100 of which were recently consolidated into multi-district litigation before a federal judge in New Jersey.
Gliflozins are not the only diabetic drugs implicated in acute pancreatitis. Earlier, the FDA issued a similar warning for sitagliptin, a prescription Type 2 diabetic drug manufactured by Merck and marketed as Januvia. Although the FDA has started an investigation, the federal regulatory agency says that because gliflozin has been identified as a potential risk for pancreatitis does not necessarily mean that such a risk exists. The FDA has identified it as a “potential safety issue,” and is “evaluating the need for regulatory action.”
In addition to Invokana, a product of Johnson & Johnson, other drugs in the gliflozin class that have been implicated in acute pancreatitis include Farxiga (daoagliflozin), developed by AstraZeneca in conjuction with German-based Boehringer-Ingelheim, and Jardiance (empagliflozin) from Eli Lilly.
If the FDA determines that gliflozin drugs are indeed a risk factor in the development of acute pancreatitis, it may require updated package labeling. Alternatively, the agency may decide that additional data is required. The third alternative would involve coming up with what is known as a “Risk Evaluation and Mitigation Strategy,” which would determine if the risk of side effects is outweighed by the potential benefits of the drugs.