For the past decade, diabetes drugs have been among the best-selling pharmaceuticals in the United States. However, they have also been the subject of frequent safety debates and FDA warnings about patient side effects.
In just the past five years, warnings have surfaced over heart risks for Avandia, bladder cancer for Actos, pancreatitis for Januvia and joint pain for Onglyza and Janumet.
Now, the FDA has warned that Invokana (canagliflozin) can weaken patients’ bones and even lead to bone fractures. The alert comes just months after a May warning that the drug may cause a dangerous blood condition called ketoacidosis.
In the latest warning, issued September 10th, the agency acknowledges that Invokana’s label has addressed risks for bone problems in its fine print since it was approved in 2013. However, they have added stronger warnings due to new data from a study they required of the drug’s manufacturer, Johnson & Johnson.
In a recent study of 714 elderly patients taking both Invokana and a placebo, data showed those taking Invokana were more likely to suffer bone fractures as soon as 12 weeks after starting treatment. It also showed patients were more likely to suffer loss of bone density, or strength, over a two-year period.
Invokana is part of a class of diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. These meds reduce high levels of blood sugar that come with diabetes by forcing the kidneys to carry it out with urine.
For now, the added warning only applies to Invokana, and not other drugs in the SGLT2 class like Farxiga and Jardiance. However, the FDA is monitoring ongoing bone density studies for these drugs to determine if further warnings are needed.
According to the FDA, doctors who prescribe Invokana should look for outside risk factors for bone fractures and weakness before doing so. However, patients taking the drug should not stop treatment without first talking with their doctor.
Lawyers fear that thousands of patients may have suffered bone fractures and density loss without knowing the cause due to the improper warnings up until now. They are currently investigating lawsuits against Johnson & Johnson for those affected.
Contact DrugNews for more information on Invokana warnings and the new lawsuits for ketoacidosis, kidney damage and bone injury.
FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density. (September 10, 2015). Retrieved from www.fda.gov
Palmer, E. FDA warning on J&J's Invokana adds more complexities to diabetes drug battles. Fierce Pharma. (September 11, 2015). Retrieved from www.fiercepharma.com
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