In a recent development in the rising concern over the popular diabetes medications, the FDA has strengthened warnings against Invokana (Canagliflozin).

According to the federal agency, this popular type-2 diabetes medication could potentially cause bone fractures and decrease mineral density in bones.

The concern over these products emerged in addition to the FDA warning that certain type-2 diabetes treatment drugs could increase the patients’ chances of developing kidney failure and ketoacidosis.

The most recent addition to the list of type-2 diabetes treatment drugs side effects came on Sept. 10, with the FDA specifically calling out Invokana for increasing the risk of bone fractures and possibly lowering bone density.

The federal agency is continuing to investigate these diabetic medications to determine whether label changes or other adjustments may be necessary.

Overview of Diabetes Medications Complications

The most recent drug safety communication release from the FDA stated that it has been decided to add a new precautionary warning to Invokana’s warning label, after reviewing recent studies and patient injury reports.

In particular, a 2014 study from the Lancet Diabetes & Endocrinology indicated that Invokana and other sodium-glucose contransporter-2 (SGLT2) inhibitors could cause bone fractures in patients.

It is important to note that SGLT2 inhibitors were approved by the FDA to be safe and effective treatment medications for type-2 diabetes patients. These drugs lower blood sugar by signaling the kidneys to remove sugar from the body, through urination.

The FDA’s study indicated that this risk was most prevalent in postmenopausal women; the researchers also cited numerous studies showing similar observations indicating a link.

Another contribution to the FDA’s decision was after an evaluation was performed, involving nine pooled clinical trials that had an average drug exposure of 85 weeks.

The bone fractures occurred the least in the placebo group at 1.1 percent, then 1.4 percent for patients on a low dose of Invokana, and 1.5 percent for patients with a higher dose of Invokana. The study indicated that the fractures were most likely to be of low trauma, while mainly effecting the upper extremities.

To further investigate this concern, the FDA reviewed a trial consisting of 714 patients that was conducted for post-marketing safety evaluation. The study lasted for two years, with smaller prescriptions of the drug indicating less likelihood of bone density issues.

After this extensive research process, the FDA ultimately decided that an additional warning would be added to Invokana’s label, stating that bone fractures have been seen in patients and that they can occur as early as 12 weeks.

Moreover, Invokana could potentially decrease bone mineral density in the hip and lumbar spine. The FDA also warned physicians against prescribing this drug without carefully evaluating the patient’s health.

Other side effects patients could suffer include dehydration, kidney problems, low blood sugar, high potassium levels in blood, high cholesterol, and yeast infections.

Overall, the FDA encourages all medical care professionals and patients to report any adverse effects they may suffer from Invokana to their MedWatch Safety Information and Adverse Event Reporting Program.