New Study By SLGT-2 Manufacturer Claims Drug Lowers the Risk of Heart Disease – But At What Risk? | Levin Papantonio - Personal Injury Lawyers

New Study By SLGT-2 Manufacturer Claims Drug Lowers the Risk of Heart Disease – But At What Risk?

A recently published “real world” study of gliflozin drugs such as Invokana concluded that such medications can lower the risk of death from heart disease by up to 39%. Aside from the fact that the study was sponsored by AstraZaneca, which is promoting its own gliflozin drug (Farxiga), one must ask – given the danger of other side effects, particularly diabetic ketoacidosis and kidney damage, does this benefit outweigh the risk?

When Johnson & Johnson subsidiary Janssen Pharmaceuticals first sought approval for Invokana, the review committee expressed doubts for a couple of reasons. First, the company sponsored its own study, raising concerns that the data was manipulated. Secondly, 13 patients who were at risk for cardiovascular disease wound up suffering a stroke or a heart attack within the first month (whereas among the placebo group, only one such participant experienced a cardiac event). It was also noted that Invokana could cause elevated levels of LDL cholesterol. Nonetheless, FDA approval was granted, over the objections of five of the fifteen members of the approval committee. However, no warnings about heart attacks or strokes were included with the label.

And now, a manufacturer of a similar drug is trying to convince the public that medications of the gliflozin class should be given to patients at risk for heart disease.

As it is, ketoacidosis (elevated acid in the blood) is already the most serious side effect. What is interesting is that ketoacidosis normally occurs in patients with Type 1 (genetic, childhood-onset) diabetes who regularly run glucose levels of 300 or more, which such medications are not designed to treat. It isn't normally a risk for Type 2 diabetics – until they start taking a gliflozin drug such as Invokana. It is especially dangerous for Type 2 diabetics who control their blood sugar levels with a low-carb diet or a “paleo” diet.

Other side effects that have come to light include osteoporosis (reduced bone density) and an increased risk of lower limb amputations.

Ironically, when compared to the old standby, metformin (glucophage), Invokana taken by itself was not nearly as effective at controlling blood sugar levels. In fact, independent clinical evidence (as opposed to that from industry-funded studies) indicates that all gliflozin drugs are at best, useless.

Now, Big Pharma is attempting to convince the public that they should take Invokana and other gliflozin medications in order to reduce their risk of heart problems.

Given the track record of companies like Johnson & Johnson, which have repeatedly demonstrated a complete disregard for human safety when it comes to selling defective and dangerous products – and considering that claims of heart disease prevention are based on a study bought and paid for by the industry itself – would you risk such a treatment?