Category: Defective Drugs

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Invokana May Cause Bone Fractures

Another FDA warning slapped on popular diabetes drug, Invokana
Man With Broken Bone In Wheelchair

On September 10, 2015 the FDA strengthened a warning about the risk of bone loss for those taking Invokana and Invokamet (canagliflozin) to treat type 2 diabetes. This is the second recent warning for Invokana which has also been linked to a risk of kidney disease and diabetic ketoacidosis.Man With Broken Bone In Wheelchair

Johnson & Johnson’s Invokana is part of a new class of type 2 diabetes drugs, SGLT2 inhibitors. Approved by the FDA in 2013, Invokana is on track to make blockbuster status this year with nearly $6M in sales in the first 6 months.

The FDA has new information based on clinical trials on bone fracture risk and decreased bone mineral density among patients taking Invokana. A 2 year study of 714 elderly diabetics found that those taking this SGLT2 drug lose more bone density in their hips [...]

Invokana Risk Of Bone Fractures

FDA Issues Another Invokana Warning
Wheel Chair

Last week the FDA increased their warning of the increased risk between bone fractures and type 2 diabetes medications, Invokana and the combo drug Invokamet. They have revised the drug’s labels adding information about decreased bone density and the risk of hip and lumbar spine fractures. Fractures have been reported as early as 12 weeks after beginning treatment.

The FDA had already listed bone fractures as a possible side effect. However, after reviewing the results of a 2 year postmarketing study of 714 elderly patients with type 2 diabetes, they concluded that drugs containing canagliflozin, an SGLT2 inhibitor contained in Invokana and Invokamet carried a serious risk of fractures. The FDA is still evaluating whether to order studies or increase warnings on other SGCLT2 diabetes drugs such as Farxiga and Jardiance.

Approved in 2013, Invokana and Invokamet have performed well for drug manufacturer, Janssen Pharmaceuticals, Inc. earning top dollars [...]

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