Follows evidence linking the SGLT2 inhibitor to fractures
The FDA strengthened the warning for type 2 diabetes drug canagliflozin (Invokana, Invokamet) to note that the drugs may increase the risk of bone fracture and decrease bone mineral density.
In a drug safety communication, posted today, the agency said they have added a new warning and precaution and have revised the adverse reactions section of the drug labels to reflect this fact.
Last year, a researcher wrote in Lancet Diabetes & Endocrinology that there is a possible relationship between the drug, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, and bone fractures, especially for post-menopausal women. She cited numerous studies showing a possible link as evidence.
The FDA said that healthcare professionals should consider factors that may contribute to fracture risk before starting their patients on canagliflozin. They also added the following information:
More here: http://www.medpagetoday.com/Endocrinology/Diabetes/53490?
The FDA strengthened the warning for type 2 diabetes drug canagliflozin (Invokana, Invokamet) to note that the drugs may increase the risk of bone fracture and decrease bone mineral density.
In a drug safety communication, posted today, the agency said they have added a new warning and precaution and have revised the adverse reactions section of the drug labels to reflect this fact.
Last year, a researcher wrote in Lancet Diabetes & Endocrinology that there is a possible relationship between the drug, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, and bone fractures, especially for post-menopausal women. She cited numerous studies showing a possible link as evidence.
The FDA said that healthcare professionals should consider factors that may contribute to fracture risk before starting their patients on canagliflozin. They also added the following information:
- Bone fractures have been seen in patients on canagliflozin
- Fractures can occur as early as 12 weeks after starting the drug
- In addition to bone fractures, canagliflozin has also been linked to decreases in bone mineral density at the hip and lumbar spine
More here: http://www.medpagetoday.com/Endocrinology/Diabetes/53490?