According to a new observational study published in the BMJ in the November 2018 issue, a class of type 2 diabetes medications called sodium-glucose cotransporter-2 (SGLT2) inhibitors has been associated with twice the risk of lower limb amputations compared with other type 2 diabetes medications.
The BMJ study reports that SGLT2 inhibitors are associated with serious complications. About 17,213 patients took SGLT2 inhibitors, and 17,213 patients took GLP1 receptor agonists from July 2003 to December 2016. The main outcomes of the study were:
- Lower limb amputation
- Bone fracture
- Diabetic ketoacidosis
- Acute kidney injury
- Acute pancreatitis
Despite the serious potential for adverse effects, only Invokana (canagliflozin) has an FDA “black box” warning label for increased amputation risks, which was issued in May 2017.
In another study published in the September issue of JAMA Internal Network, “Association Between Sodium-Glucose Cotransporter 2 Inhibitors and Lower Extremity Amputation Among Patients With Type 2 Diabetes,” researchers found that SGLT-2 inhibitors may be associated with an increased risk of amputation compared with some oral treatments for type 2 diabetes.
In 2015, the FDA issued a safety warning about the danger of ketoacidosis, and the danger of decreased bone density, which increases the risk of fracture in patients taking type 2 diabetes drugs, specifically, the SGLT-2 inhibitors such as Invokana, Farxiga and Jardiance. Despite the dangerous risks from taking them, these drugs are still being marketed and sold to people with type 2 diabetes.
Symptoms of diabetic ketoacidosis
Diabetic ketoacidosis is a dangerous buildup of acids, called ketones, in the blood. Per the Mayo Clinic, symptoms can develop within 24 hours. The Clinic lists the following symptoms:
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal pain
- Weakness or fatigue
- Shortness of breath
- Fruity-scented breath
Diabetic ketoacidosis can be life-threatening if not addressed immediately. If you are unable to bring your blood sugar levels down, seek medical attention immediately.
SGLT2 inhibitors and flesh-eating genital infections
In August 2018, the FDA issued a safety warning about a rare, but serious, infection of the genital area from using SGLT2 inhibitors. The condition – necrotizing fasciitis of the perineum – is also called Fournier’s gangrene. The FDA recommends that patients seek medical attention immediately if they experience symptoms of tenderness, redness or swelling of the genitals, or have a fever of 100.4 F° or a general feeling of being unwell. The symptoms worsen quickly so it is important the you seek medical attention immediately.
Adverse effects from defective drugs can cause serious complications. Some adverse effects from defective drugs can lead to death. When a person has sustained harm or injury from a dangerous drug, he or she may have grounds for a products liability lawsuit.
For more than 40 years, Barry J. Nace has worked to protect the rights of victims of medical malpractice and other personal injuries. Throughout his career, he has proven that multimillion-dollar awards are not a matter of luck, but the result of experience, hard work, outstanding trial skills, and an unquestioned dedication to justice. To date, Mr. Nace has produced dozens of verdicts and settlements in excess of $1 million with three in excess of $30 million. Read more about Barry J. Nace.