To address cardiovascular concerns and gather more information about canagliflozin’s long-term safety and efficacy, the FDA is requiring five post-marketing studies: a cardiovascular outcomes trial, a “pharmacovigilance” trial (to monitor for cancers, pancreatitis, hypersensitivity reactions, photosensitivity reactions, liver problems, and pregnancy outcomes), a bone safety study, and two pediatric studies.
Canagliflozin may not work as well in people who take rifampin (an antibiotic), phenytoin or phenobarbital (both anticonvulsants), or ritonavir (a protease inhibitor). Canagliflozin may increase the concentration of the drug digoxin (brand name Lanoxin) in the bloodstream; if you’re taking digoxin with canagliflozin, your digoxin concentration should be monitored more frequently.
Who should take it?
Until more data is available, particularly data about canagliflozin’s effect on cardiovascular health, the drug should be used as an add-on to metformin only after a person has tried other, more established diabetes drugs. If you do start taking canagliflozin, be sure to keep yourself well hydrated, and make sure your health-care provider monitors your kidney function.