Invokana Problems Lead to Review by European Medicines Agency (EMA)

Following recent warnings by the FDA, European drug regulators are investigating the potential side effects of Invokana and other similar diabetes drug that are part of a new class of medications linked to problems where users may face a dangerous build-up of acid levels in the blood, known as ketoacidosis. 

On May 27, the European Medicines Agency (EMA) added Invokana and other drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors to a list of medications that will undergo additional monitoring. The agency reports that it is looking for cases of potentially life-threatening ketoacidosis problems with Invokana and Vokanamet, which is a combination of Invokana and metformin.

The review comes after a recent FDA warning about the risk of ketacidosis from Invokana and other members of this new class of diabetes drugs on May 15. The U.S. regulatory agency indicated that at least 20 cases of diabetic ketoacidosis (DKA) were reported during the first 15 months Invokana was on the market, with all of the cases involving hospitalization or emergency room treatment.

Ketoacidosis is a serious and potentially life threatening medical condition that occurs when high levels of blood acids, known as ketones, build up in the blood. This can result in difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment.

Since the FDA statement earlier this month, a number of product liability lawyers have begun investigating potential Invokana lawsuits over the drug maker’s failure to adequately warn consumers and the medical community.

As a result of the regulatory reviews by both the FDA and EMA, more stringent warnings may be required for Invokana and other drugs in the same class, such as Farxiga, Glyxambi, Jardiance, and Xigduo XR.

Invokana Safety Concerns

Concerns over the risk of Invokana problems have been expressed by experts since the diabetes drug was introduced in March 2013, as the first member of this new class of medications that work by inhibiting some kidney functions to increase the amount of sugar excreted in the urine.

Earlier this month, a report released by the Institute of Safe Medication Practices (ISMP) questioned whether the Invokana risks may actually outweigh the benefits provided by the drug.

During the first year the drug was on the market, ISMP highlighted 457 serious adverse event reports submitted to the FDA involving complications from Invokana. These adverse event reports typically only account for a small portion of the total problems associated with prescription medications on the market.

Many of the reported Invokana problems involved kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss. Looking at reports to the FDA’s adverse event reporting system, the ISMP found that Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group.

The ISMP report found that at the cost of those risks came very few benefits. According to the report, the Invokana clinical trials showed that the drug typically lowered levels of glycated hemoglobin (HbA1c), a primary type 2 diabetes blood sugar measurement, by about only one percent. It also caused weight loss of a mean of five to six pounds in users.