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News Brief for February 2016

Worst Pills, Best Pills Newsletter article February, 2016

FDA Issues Safety Warnings About Dangerous Diabetes Drugs

In September[1] and December[2] of last year, the Food and Drug Administration (FDA) issued safety notices about diabetes drugs known as SGLT2 inhibitors, more commonly known as “flozins.” This family of drugs includes canagliflozin (INVOKAMET, INVOKANA), dapagliflozin (FARXIGA) and empagliflozin (JARDIANCE). In the September notice, the FDA stated that canagliflozin has been linked to decreases in bone mineral density as well...

FDA Issues Safety Warnings About Dangerous Diabetes Drugs

In September[1] and December[2] of last year, the Food and Drug Administration (FDA) issued safety notices about diabetes drugs known as SGLT2 inhibitors, more commonly known as “flozins.” This family of drugs includes canagliflozin (INVOKAMET, INVOKANA), dapagliflozin (FARXIGA) and empagliflozin (JARDIANCE). In the September notice, the FDA stated that canagliflozin has been linked to decreases in bone mineral density as well as an increased risk of fracture. Fractures can occur as soon as 12 weeks after starting canagliflozin. The December communication noted an addition to warning labels on all SGLT2 inhibitors about the risks of ketoacidosis (a dangerous buildup of acid in the blood) and of serious urinary tract infections with the use of these drugs.

Public Citizen’s Health Research Group lists all of these drugs as Do Not Use because their serious risks outweigh their benefits.[3]

References

[1] Food and Drug Administration. 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. http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm. Accessed December 17, 2015.

[2] Food and Drug Administration. FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. Updated December 4, 2015. http://www.fda.gov/drugs/drugsafety/ucm475463.htm. Accessed January 11, 2016.

[3] Risks but No Benefits to Taking Newest Drugs for Type 2 Diabetes. Worst Pills, Best Pills News. August 2015. /newsletters/view/981. Accessed January 11, 2016.