Federal regulators and medical professionals are warning that a newer class of drugs used to treat Type 2 diabetes can cause some serious, potentially life-threatening side-effects. Patients taking these medications may face an elevated risk of heart attack, stroke, blood abnormalities, or kidney failure. And yet, in spite of all of these concerns, the pharmaceutical companies that produce these drugs continue to spend millions of dollars marketing them to sufferers of Type 2 diabetes.
Known as sodium-glucose cotransporter 2 (SGLT2) inhibitors, the drug category includes Invokana®, Farxiga®, Glyxambi®, and Jardiance®, among others. In the 3 years since they first hit the market, SGLT2 inhibitors have been the focus of numerous public health notices, consumer warnings, marketing controversies, and lawsuits.
Acid in the Blood
The controversy that’s emerged within the drugs’ relatively short history only adds to concerns about possible long-term side-effects. Regulators in Europe, the U.S., and Canada have already reported a link between SGLT2 inhibitors and a troubling blood condition known as ketoacidosis, in which the body produces an excessive level of acid that can poison the body and lead to nausea, fatigue, confusion, abdominal pain, breathing problems, and urinary tract infections.
Last year, the U.S. Food and Drug Administration (FDA) beefed up warning labels attached to Invokana and other SGLT2 inhibitors, claiming in December that patients should “stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis.”
In February, the European Medicines Agency (EMA) took a similar step and recommended SGLT2 inhibitors be relabeled to account for an elevated risk of ketoacidosis. Unfortunately, though, the condition may be just one of many adverse side-effects associated with these drugs. A whole host of cardiovascular problems were reportedly listed during clinical trials, and those side-effects alone — which included bone frailty, stroke risk, blood clots, and high cholesterol, among others — were enough for the consumer rights group Public Citizen to claim SGLT2 inhibitors should be avoided outright.
There is growing concern that the makers of Invokana and other SGLT2 inhibitors withheld critical information in their marketing practices — information that might have deterred patients from taking the drug and prevented any sickness or injury they may have suffered.
In its research, the FDA identified dozens of cases of ketoacidosis caused by SGLT2 inhibitors — all of which required hospitalization or emergency care. Regulators also discovered several incidents of blood and kidney infections caused by the drug.
Nearly 30 million people in the U.S. suffer from diabetes, and more and more are being diagnosed every day. To account for this rise, pharmaceutical companies are looking for alternative ways to treat the disease and lessen its symptoms.
As oral medications, SGLT2 inhibitors were introduced as a way to lower blood sugar levels in patients without having to rely too heavily on intrusive and inconvenient insulin pumps or injections. It sounds nice in theory, but when the risks begin to “outweigh the benefits,” as Public Citizen claims SGLT2 inhibitors do, the drug makers should be expected to (at the very least) reflect that reality in their marketing. And that doesn’t appear to have happened.
This may prove a troubling turn of events for Janssen Pharmaceuticals — the Johnson & Johnson (J&J) subsidiary that produces Invokana, the top-selling SGLT2 inhibitor. Both Janssen and J&J have faced a rising tide of lawsuits and controversies in recent years, most of which allege that the company repeatedly engaged in false or illegal marketing practices.
While a suit hasn’t yet been filed against the multi-billion-dollar corporation for its Invokana marketing, it’s safe to assume there will be one in the future. According to Bloomberg Business, J&J has paid out nearly $20 Million to doctors and hospitals to promote Invokana®. While that is not direct evidence of misconduct, it may soon prove to be a smoking gun. And that’s just J&J. AstraZeneca has claimed its SGLT2 inhibitor, Farxiga®, has helped to grow sales for the entire class by over 115 percent.
Right now, both companies are boasting about sales of their diabetes drugs, but those figures could come back to haunt them as more and more patients come forth with reports of adverse, and potentially life-threatening, side-effects. It’s key to remember that SGLT2 inhibitors have only been around since 2013. So, when it comes to long-term side-effects, it’s really anyone’s guess.
If you’ve been diagnosed with ketoacidosis or any other health problem related to a Type 2 diabetes drug, contact Sokolove Law for a free consultation. You may be entitled to compensation for your injuries.