Farxiga Fares No Better Than Placebo At Preventing Major Heart Problems, But Lowers Death Risk: Study

According to the findings of a new study, Farxiga appears to fare no better than a placebo at preventing major cardiovascular events, such as heart attacks, but may lower the risk of death from heart failure. 

Researchers from around the world participated in the Thrombolysis in Myocardial Infarction (TIMI) Study Group, and published findings last week in the New England Journal of Medicine, which looked at the cardiovascular safety profile of Farxiga (dapagliflozin). The researchers found it did little to prevent heart attack or stroke, and was linked to an increased risk of diabetic ketoacidosis and a rare form of genital infection.

Farxiga is a diabetes drug which belongs to a class of medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. The class also includes Jardiance, Invokana, Invokamet, Xigduo XR and others. A number of studies have suggested that the drugs could provide heart benefits to patients, however, they have also been linked to a number of serious health risks as well.

This latest clinical trial followed 17,160 patients for a median of 4.2 years, assigning participants to either Farxiga or a placebo. The researchers then looked for major adverse cardiovascular events (MACE), which are defined as cardiovascular death, myocardial infarction or ischemic stroke. They also looked at hospitalization for heart failure.

According to the findings, Farxiga did not result in a lower rate of MACE overall, but researchers did see a drop in cardiovascular death or hospitalization for heart failure.

Farxiga was linked to a higher rate of diabetic ketoacidosis, with 0.3 percent of patients given Farxiga suffering the life-threatening condition, compared to only 0.1 percent of patients given a placebo. Those given Farxiga also faced a much higher rate of genital infections, which afflicted 0.9 percent of Farxiga users, compared to only 0.1 percent of placebo users.

Farxiga Health Risks

Farxiga, Invokana and similar drugs have been linked to a growing number of adverse health risks. Most recently, in August 2018, the FDA issued a warning linking the drugs to serious flesh-eating infections around the genitals, known as necrotizing fasciitis of the perineum, or Fournier’s gangrene.

The previous warnings have included kidney failure, diabetic ketoacidosis and amputations (specifically for Invokana). The drugs did not carry warnings for any of those risks when they were first approved by the FDA.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Farxiga and similar drugs, indicating that the medications increase the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.

In June 2016, the FDA required additional label warnings about the link between kidney risks and Farxiga and other drugs from its class, indicating that the medications may increase the risk of acute kidney injury and other severe health problems.

Johnson & Johnson and Janssen face several thousand Invokana lawsuits, which allege that users and the medical community were not provided adequate warnings at the time the drug was first introduced. The makers of other diabetes drugs from the same class, including Farxiga and Xigduo XR, have also faced similar lawsuits; though most have been filed against the makers of Invokana.

The FDA indicates that there were 1.7 million prescriptions dispensed for SGLT2 inhibitors in 2017.