Introduction
INVOKANA is commonly prescribed to improve glycemic control (blood sugar) in adults with type 2 Diabetes Mellitus.1
The Institute for Safe Medication Practices, an independent health nonprofit group that monitors FDA reports, has questioned Invokana’s clinical benefits and whether those benefits outweigh its risks. Invokana was approved by the FDA in March of 2013. At the time of FDA approval, Invokana had not been tested in a enough patients for a long enough period of time to answer that question. 2
History of the Case
The U.S. Food and Drug Administration issued a warning in May of 2015 stating that Invokana and similar medicines that treat type 2 Diabetes may lead to a serious condition where the body produces high levels of blood acids called keytones that may require hospitalization.3
In September of 2015, the FDA strengthened the warning for Invokana related to the increased risk of bone fractures and added new information about decreased bone mineral density (relating to the strength of a person’s bones). 4
These warnings came over two years after the drug became available to patients.
Injuries Related to Product
Some injuries that have been linked to Invokana include:
- Ketoacidosis (high levels of blood acids)
- Kidney Failure or Impairment
- Severe Dehydration or Fluid Imbalance
- Increased Risk of Bone Fractures
- Kidney stones
- Urinary Tract Infection
- Abnormal Weight Loss
Additional Literature
- 1 Invokana Product Information
- 2 ISMP Quarter Watch May 6, 2015
- 3 FDA Warning Safety Announcement, May 15, 2015
- 4 FDA Warning Safety Announcement, September 10, 2015
- 5 ISMP Quarter Watch May 6, 2015
