Invokana

Diabetes, a group of chronic conditions that result in too much sugar in the blood, is a problem affecting 30 million people in the U.S., or roughly 9 percent of the population, according to the American Association of Diabetes Educators. If untreated, diabetes can cause serious health complications and even death.

Invokana, also known as canagliflozin, was approved by the U.S. Food and Drug Administration in 2013 for treatment of people with type 2 diabetes for help with control high blood sugar. It’s an SGLT2 inhibitor, which means it works by reducing blood glucose levels. It’s manufactured by pharmaceutical powerhouse Johnson & Johnson, which touted Invokana as a breakthrough in diabetes treatment.

Unfortunately, as the Salt Lake City Invokana injury attorneys at The James Esparza Law Group know, numerous complications have come to light. Specifically, following interim clinical trials, regulators are requiring warnings on Invokana prescription labels regarding the heightened risk of leg and foot amputations (mostly affecting toes) by those who take the drug.

Additionally, the drug has been linked to a condition called ketoacidosis, which the American Diabetes Association explains involves:

• Breathing trouble;
• Nausea;
• Vomiting;
• Abdominal pain;
• Confusion;

Cardiovascular side effects also have not been entirely ruled out either. Prior to FDA approval of Invokana, eight of the 15 reviewing panel members expressed concerns about cardiovascular safety, citing a clinical study showing more than a dozen heart attacks involving patients who took Invokana, versus one who took the placebo.

The FDA has also released warnings that Invokana was associated with acute kidney injuries, in some cases involving hospitalization. These renal side effects, as well as amputations, are the prime source of Invokana litigation.

Invokana History

Invokana was initially developed by Mitsubishi Tanabe Pharma, but it’s manufactured and marketed by Janseen, a division of Johnson & Johnson.

Invokana was initially developed by Mitsubishi Tanabe Pharma, but it’s manufactured and marketed by Janseen, a division of Johnson & Johnson.

Manufacturers received the FDA stamp of approval for the drug in March 2013, though with a 10-to-5 vote, highlighting the fact there were obvious concerns from the start. As The New York Times reported, several members disclosed they did not think the drug should be taken by patients with moderate kidney disease. Additionally, the drug was not as effective for some individuals, and those with kidney disease were at higher risk for adverse side effects, compared to those without it. However, the warning label only denoted those with serious kidney disease should refrain. At the time Invokana obtained approval, the FDA had just rejected approval for dapagliflozin, another medication in that same class, for safety concerns that included the possibility of higher risk for bladder and breast cancers.

Although manufacturers hailed Invokana as a breakthrough as the first of a new class of type 2 diabetes medications, our Invokana injury lawyers in Utah now know it is associated with severe and even life-threatening side effects.

At the same time the approval was announced, the FDA required manufacturers to conduct five post-marketing studies, including clinical trials to ascertain whether Invokana increases the risk of strokes and heart attacks. The drug was released without any warning labels regarding those potential risks. Sales of Invokana topped more than $1 billion in 2016, exceeding initial expectations that they would reach $670 million by that year.

Still, the FDA has issued serious warnings about the potential side effects since the drug hit the market.

In 2015, the FDA revised labels of SGLT2 inhibitors such as Invokana to include warnings for a condition known as ketoacidosis, which is a serious condition that involves too much acid in the blood, as well as heightened risk of serious urinary tract infections.

In 2016, the FDA issued a Drug Safety Communication, indicating canagliflozin (which includes drugs Invokana, Invokamet and Invokamet XR) put patients at higher risk of leg and foot amputations, based on two new large clinical trials.

The research showed leg and foot amputations happened doubly often in patients with type 2 diabetes treated with Invokana, compared to those who were given a placebo. Amputations of the middle of the middle of the foot and toe were the most common, but amputations of the leg, both above and below the knee, also occurred. Patients were instructed to talk to their doctors immediately if there were signs of tenderness, sores or ulcers or infections in the legs and feet. Doctors were instructed to carefully consider patient risk factors (i.e., prior amputation history, neuropathy and peripheral vascular disease) before deciding whether to prescribe the drug, and carefully monitor patients who are taking it.

Also that year, the non-profit ISMP (Institute for Safe Medication Practices) reported nearly 7,500 adverse events linked to Invokana use.

The following year, the FDA issued another a Drug Safety Communication, noting the issues described below were addressed with product labeling. Specifically, an updated “black box warning” label was issued for the medication, noting the increased amputation risk. Black box warnings are those that appear on a drug’s label and are intended to call attention to either serious or life-threatening health risks. They are reserved for the most serious possible negative side effects.

.