Invokana Side Effects Carry Risk of Ketoacidosis in Type 1 Diabetics: Study

Amid mounting concerns about the side effects of Invokana, a new generation diabetes drug that has been linked to a number of health problems in recent months, a new study suggests that the medication may increase the risk of ketoacidosis among Type 1 diabetics even more than it does for Type 2 diabetics.

The study was conducted by Johnson & Johnson’s Janssen subsidiary, which manufactures Invokana, and the findings were presented last month at the American Diabetes Association Annual Scientific Sessions in New Orleans.

According to a press release issued by the drug maker, which touts the potential benefits of combining Invokana and insulin to improve glycemic control among individuals with type 1 diabetes, the findings also suggest that the drug make increase the risk of serious adverse events known as diabetic ketoacidosis, which involve a build up of acid levels in the blood,

Invokana (canagliflozin) was introduced in March 2013, as the first member of a new class of drugs approved for treatment of type 2 diabetes, which is an acquired disease, as opposed to type 1 diabetes, which individuals are born with.

The aim of the latest study was to test Invokana’s effectiveness at treating type 1 diabetics, and the findings may be used to obtain expanded approval for the controversial new generation drug, which has required a number of warning updates since it hit the market only three years ago.

While the study found better glycemic control was attained by type 1 diabetics who took Invokana, Janssen also admitted in the press release that there was “an increase in serious adverse events related to ketoacidosis.” The release does not include numbers for the increased risks and the study has not yet been published for peer review.

Ketoacidosis is a serious medical emergency linked to Invokana side effects, which causes an increase in the body’s blood acid levels and usually results in serious injury and hospitalization. It can also lead to coma and death.

In December 2015, the FDA required Janssen to update the warning label to provide information about the link between Invokana and ketoacidosis. However, type 1 diabetics start out at an increased risk of ketoacidosis. In fact, one of the clues that Invokana was causing the problem in type 2 diabetics is that they rarely experience the condition.

Other Invokana Health Risks

Shortly after Invokana was approved in the U.S., the drug makers began to aggressively promote the treatment and a number of type 2 diabetics were switched to the new treatment. However, as more and more individuals used it, a steady stream of safety signals have emerged, raising questions about whether the drug makers adequately researched the medication and placed their desire for profits before consumers safety.

In addition to the ketoacidosis warnings, the FDA also required the drug makers to update the warning label in September 2015, adding information about a potential Invokana bone fracture risk, indicating that the drug may lead to decreased bone density and breaks.

In early June 2016, the FDA also released a new Invokana safety warning, indicating that the may increase the risk of leg, foot, and toe amputations. However, the investigation into those potential side effects are ongoing.

There are also increasing concerns about a link between Invokana and kidney problems, as the drug works in a unique way by impacting the normal functioning of the kidneys.

The kidney risks were first highlighted by an independent review of adverse event reports submitted to the FDA during the first year Invokana was on the market. In May 2015, the Institute of Safe Medication Practices (ISMP) released a report highlighting 457 reports involving problems with Invokana or other members of this same new class of diabetes drug, including instances of kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss.

The ISMP indicated that the FDA received more serious adverse event reports involving Invokana than 92% of the other drugs regularly monitored by the group, suggesting that the risks associated with the drug may outweigh the benefits.

On June 14, the FDA appeared to agree with the ISMP’s concerns and issued a drug safety communication ordering the makers of Invokana, Invokamet, Farxiga and Xigduo XR to add stronger label warnings about the risk of kidney damage as well. The warning came after the FDA confirmed more than 100 adverse event reports involving patients who suffered acute kidney injury, which may cause hospitalization or potentially lead to kidney failure and death.

Johnson & Johnson now faces a growing number of Invokana lawsuits filed in recent months over problems associated with the diabetes drug, seeking damages for individuals who suffered diabetic ketoacidosis, kidney failure, heart attacks, strokes and other injuries.