There has been a great deal of controversy over a new class of diabetes medications called SGLT2 inhibitors. This class of drugs includes Invokana®, Invokamet®, and Jardiance®, all of which have some rather troublesome side effects.
Medication Overview
The FDA recently approved several new diabetes medications called SGLT2 (sodium-glucose co-transporter-2) inhibitors. This class of drugs has some troublesome side effects with even more drugs in this class pending FDA approval. The first of these drugs to be available for use was canagliflozin, marketed as Invokana. It is also sold with the addition of metformin (Invokamet).
SGLT2 inhibitors work to lower blood sugar by preventing the kidneys from absorbing glucose, and allowing it to pass from the body through urine. Recent findings have indicated that even though these medications increase the amount of glucose that exits the body, they stimulate the secretion of glucagon and ultimately increase the production of glucose.
History of Side Effects
When Invokana first came up for approval, a committee of experts was apprehensive about it because they had conducted their own clinical study of patients who were at high risk for cardiovascular disease. Their study showed 13 patients taking the drug suffered either strokes or heart attacks (mostly strokes) within the first 30 days. Even though the imbalance was later reversed, they also noted a minor increase in LDL cholesterol.
Although the FDA initially delayed approval of any other drugs in this class because of some serious concerns, they eventually approved them. It only took a few years before serious side effects of the first drug that was released for widespread use began to rear their ugly heads.
In May of 2017, the FDA issued a new black box warning (most prominent type of boxed warning) for Invokana, based on the results of two large clinical trials. The trials showed that leg and foot amputations occurred about two times as often in patients treated with Invokana (canagliflozin) compared to patients treated with placebo.
The FDA says that amputations of the toe and middle of the foot were the most common. Amputations of the leg also occurred, and some patients suffered more than one amputation.
Serious Side Effects of SGLT2 Inhibitors
There are some serious side effects related to the use of SGLT2 inhibitors. Some of the more common side effects include:
- Ketoacidosis in Type 2 diabetics, which is a condition that usually only affects Type 1 diabetics who have blood sugars in excess of 300 mg/dl. In the cases that reportedly occurred with Type 2 diabetics, the blood sugars were only modestly elevated. In all probability, the ketoacidosis occurs because the drug makes it more difficult for the body to eliminate a buildup of ketones.
- Risk of bone fractures and decrease in bone mineral density
Other Side Effects of SGLT2 inhibitors:
- Yeast infections
- Decreased kidney function (especially in those over age 75)
Another drug that falls into the SGLT2 class is Farxiga® (also known as Xigduo), a diabetes pill that is a combination of Farxiga and metformin. The medication has the same side effects as Invokana and may possibly also increase LDL-C (bad cholesterol).
Farxiga was originally rejected by the FDA because of the dangers, but was approved in January 2014. According to studies, there were more cases of bladder cancer among those who took this drug than those who didn’t.
Although the FDA has warned consumers about the risks of SGLT2 inhibitors, they have not at the present time been recalled. There are currently investigations into the drug and its overall safety.
Consumers are being encouraged to speak to a lawyer if they suffer any side effects such as ketoacidosis or kidney failure after taking any of the SGLT2 inhibitors. Through a product liability lawsuit, you may be able to recover significant compensation for you and your family.
