A lawsuit filed in the District of New Jersey, Trenton Division alleges the diabetes medication Invokana is to blame for a patient’s stroke. The plaintiff alleges Janssen Pharmaceuticals and parent company Johnson & Johnson failed to warn about the risks. The lawsuit also accuses the companies of failing to conduct adequate clinical trials before gaining approval.
Invokana was approved in March 2013. It was the first in a new line of diabetes drugs called “sodium-glucose co-transporter 2 (SGLT-2) inhibitors”, which lower blood sugar by preventing absorption of glucose in the kidneys thus increasing its excretion in the urine. The plaintiff in the lawsuit started taking Invokana in October 2015 to control her diabetes. According to her lawsuit, she took the drug as directed. She suffered from a stroke several weeks after starting treatment. The plaintiff alleges she would not have taken the drug if she were informed of its risks.
When the FDA approved Invokana in 2013, it did so under certain conditions. Some FDA advisory committee members were concerned about cardiovascular risks, so the agency requires the manufacturers to conduct five postmarketing studies. One of the mandated trials was the “Canagliflozin Cardiovascular Assessment Study (CANVAS)”. The drug makers were already conducting this when Invokana was approved.
In 2013, data from CANVAS suggested an elevated risk of stroke associated with Invokana within the first 30 days. Findings indicated an elevated risk of 46 percent. One cardiologist on the panel voted against the drug’s approval. In response to the findings, the FDA said that “any imbalance in results during the first 30 days or the trial” in question “may be attributable to chance or may have been caused by an early increase in the risk of MACE [major adverse cardiovascular events]-plus associated with canagliflozin among subjects with high background cardiovascular risk.” The FDA also said “There was no evidence of an increased risk of MACE-plus associated with canagliflozin after 30 days”.