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The findings of a new study raise questions about prior research on the potential side effects of Invokana, Farxiga and similar diabetes drugs, indicating no link was found between use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors and bone fractures.
In September 2015, the FDA issued a drug safety communication, warning Invokana and Invokamet, which are the most widely used of the new generation diabetes drugs, could weaken bones in as little as three months after starting treatment.
The agency’s placed new warnings on the labels for SLGT2 inhibitors. However, in these latest findings presented at a recent virtual meeting of the American Society for Bone and Mineral Research, researchers from the Netherlands questioned the agency’s findings.
The study compared individuals using SLGLT2 inhibitors with those using a sulfonylurea, another class of diabetes drugs, and determined both classes increased the risk of bone fractures by only 20%. The researchers noted that a lack of glycemic control typical in type 2 diabetes can cause decreased bone quality, suggesting the fracture risk was a product of the disease and not the medications.
The study involved 6,592 new users of SGLT2 inhibitors from 2013 to 2018 with a mean age of 58. The mean body mass index was 36, which is high, and only 9% exhibited good glucose control numbers. In addition, more than a quarter of the subjects had a history of fractures already.
Researchers concluded there was no statistically significant evidence of an increased risk of bone fractures and Invokana or use of similar drugs.
By comparison, the FDA determined in 2015 that fractures occur more frequently with Invokana than with a placebo, and could begin occurring as early as 12 weeks after starting the drug. The agency also reported at the time that Johnson & Johnson’s clinical trials on changes to bone mineral density over two years showed that bone mineral density loss was seen in Invokana users in the hip and lower spine, but again was not seen in those given a placebo.
This latest study is considered preliminary until it is published in a peer-reviewed journal.