What’s the Problem?
The Institute for Safe Medication Practices (ISMP) issued a report in May that looked at the efficacy and safety of Invokana, which is manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals. Invokana is one of a several drugs labeled as SGLT2 inhibitors, which block a protein (SGLT2) from performing its function of storing sugar in the body. Other drugs in this class include:
- Xigduo XR
The ISMP report raised concerns over not only the side effects of Invokana – which include diabetic ketoacidosis and potential kidney failure – but also the clinical trials that helped the medication gain U.S. Food and Drug Administration approval.
According to ISMP, federal drug regulators received more than 450 reports of adverse events associated with Invokana use within the first year after the drug was approved. Problems included the following:
- Kidney failure
- Kidney stones
- Urinary tract infections
Patients and healthcare professionals alike are questioning why Invokana received FDA approval, since it posed such a high risk of complications.
The ISMP noted that Janssen representatives pointed out that these and other risks were posted on the drug’s warning label, with the exception of kidney stones. However, the ISMP stated that Invokana had not been sufficiently tested to ensure that its benefits justified those risks. ISMP researchers found that Invokana was associated with more serious adverse reports than more than 90 percent of other medications monitored on a regular basis.
According to the ISMP, even though the drug was tested in more than 10,000 people, there was not enough data accumulated during the clinical trials to determine whether Invokana provided a “measurable clinical benefit.” There was also not enough data, the ISMP reported, to fully determine whether or not long-term use of Invokana could lead to cardiovascular problems, increased bone fracture risk, or decline in kidney function.