One of Johnson & Johnson’s newest drugs, Invokana, is expected to reach the billion-dollar sales mark in 2015. Invokana is a drug used in the treatment of Type II diabetes, entering a market which is literally exploding. The International Diabetes Federation expects the number of diabetics worldwide to grow 52.9% (592 million people) by 2035. A significant amount of that increase will occur across the United States. Currently nearly 12% of all Americans over the age of twenty suffer from Type 2 diabetes while one-third of all Americans have pre-diabetes. Of that one-third, from 15 to 30 percent will eventually develop Type 2 diabetes.
How Does Invokana Work?
Unlike many other diabetic drugs, Invokana works by immediately attacking blood sugar, effectively reducing the amount of sugar absorbed into the bloodstream. The body then flushes out excess sugar through the urine. In more technical terms, Invokana blocks sodium-glucose co-transporter 2, an integral membrane protein.
Recent FDA Announcement Related to SGLT2 Drugs
In May 2015, the FDA warned about six medications prescribed for Type 2 diabetes which could cause ketoacidosis in those taking the drugs. This FDA warning came after the agency received 450 serious, adverse event reports. Of those, 54 reports were related to kidney failure or impairment. Invokana was among these six drugs; the FDA concluded it would continue to investigate the safety of Invokana and other drugs with the potential to cause ketoacidosis.
Johnson & Johnson First to Reach Market with SGLT2 Inhibitor Invokana
Despite the fact that Johnson & Johnson is a multi-billion dollar company, the 2010 DePuy metal hip recall and subsequent $2.5 billion settlement, placed a bit of tarnish on their family-oriented image. Invokana helped lift J & J’s sales numbers in the first quarter of 2014, bringing the company back to the forefront as the first SGLT2 inhibitor to gain FDA approval. Both Merck and Pfizer are currently developing their own SGLT2 inhibitor diabetic drugs and Eli Lilly is co-developing an SGLT2 drug with Boehringer Ingelheim. AstraZeneca garnered FDA approval for its SGLT2 inhibitor, Farxiga, in January 2014.
A Potentially Fatal Side Effect of Invokana
Knowledgeable industry experts believed at one point Invokana could not only reach “blockbuster” status by passing the $1 million mark, but could potentially achieve annual sales of more than $2 billion. These hopes may have been dashed, as a potentially fatal side effect of Invokana has come to light. In some cases dangerous levels of blood acids—known as ketoacidosis—can be triggered by Invokana, leading to coma, or even death. Diabetic ketoacidosis results from a lack of glucose to the cells in the body which causes them to burn fat, and, in turn, produces ketones.
As ketones build up in the body, it becomes more acidic, causing dry mouth, frequent urination, excessive thirst, nausea, vomiting, difficulty breathing, abdominal pain, flushed skin, confusion and extreme fatigue. As ketoacidosis progresses, death or coma can result.
Johnson & Johnson’s Failure to Warn
One of the primary issues associated with Invokana and other similar drugs, such as Invokamet, Jardiance, Xigduo XR, Farxiga and Glyxambi, is a failure to warn on the part of manufacturers and marketers. Patients were not provided information associated with an increased risk of kidney failure and ketoacidosis, therefore were not aware of potential safety risks. Obviously, many patients would have weighed the risks vs. benefits of the drug, and would have been able to make a more informed decision if they had been given all the facts about Invokana and other SGLT2 inhibitor drugs.
Invokana still has a healthy lead in sales over the next-closest competitor—AstraZeneca’s Farxiga—and is expected to grab the lion’s share of the SGLT2 market unless more consumers come forward with injuries associated with the drug.