USFDA WARNING- An increased risk of bone fracture observed with canagliflozin,SGLT-2 inhibitor.

Safety Announcement

10 Sept 2015

The U.S. Food and Drug Administration (FDA) has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures and added new information about decreased bone mineral density.

Canagliflozin  is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.

Information about the risk of bone fractures was already in the Adverse Reactions section of the drug label at the time of canagliflozin’s approval. Based on updated information about bone fractures from several clinical trials, FDA revised the drug label and added a new Warning and Precaution.

The additional data confirm the finding that fractures occur more frequently with canagliflozin than placebo, which is an inactive treatment. Fractures can occur as early as 12 weeks after starting the drug. In the clinical trials, when trauma occurred prior to a fracture, it was usually minor, such as falling from no more than standing height.

In addition, new information about the risk of decreased bone mineral density to the canagliflozin label has been added.It  decreases bone mineral density at the hip and lower spine. A clinical trial, that manufacture conducted,  evaluated changes to bone mineral density over two years in 714 elderly individuals and showed that canagliflozin caused greater loss of bone mineral density at the hip and lower spine than a placebo.

Some other possible side effects of canagliflozin include dehydration, kidney problems, low blood sugar when it is combined with other prescription diabetes medicines, a high amount of potassium in the blood, increased cholesterol, and yeast infections.



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