The diabetes drug Invokana can decrease bone mineral density and increase the risk of bone fractures after just 12 weeks, according to warnings from the FDA.
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Bone Fractures Added to Invokana Warnings
September 10, 2015 — Invokana may increase the risk of bone fractures, according to an FDA Safety Communication. The agency has updated the Warnings & Precautions to address these safety concerns.
What is the problem?
Bone fractures can occur as early as 12 weeks after starting Invokana. In clinical trials, the fractures usually occurred after minor injuries (such as falling from no more than a standing height) and affected the arms.
Studies of Invokana Bone Fracture Risk
Invokana can decrease bone mineral density in the hip and lower spine, according to studies involving 714 elderly patients who took Invokana for two years. Patients on higher doses of Invokana had higher rates of bone fractures in the studies. Patients on 100-mg doses had 0.9% less bone mass density of the hip, and patients on 300-mg had a 1.2% decline. They also had a 0.3% decline and 0.7% decline, respectively, in the lower spine.
What is a Bone Fracture?
Bone fractures are generally more serious for older adults who have brittle bones or osteoporosis. They can occur in a number of ways, including:
- Displaced: Broken pieces of the bone move and do not line up straight.
- Non-displaced: The bone cracks but does not move and maintains proper alignment.
- Closed fracture: Bone breaks but does not puncture the skin (simple fracture).
- Open or compound fracture: Bone pierces through the skin, but may recede back into the body. Higher risk of deep bone infections.
Bone fractures can cause severe internal and external bleeding. If the bone breaks the skin, bacteria can enter the body and cause infections. Patients can also go into shock, a state of physical shut-down that can cause multi-organ failure and death.
- Swelling or bruising
- Limb looks abnormal
- Pain that gets worse when the limb is moved or pressure applied
- Loss of function
- Bone protruding under or through the skin
In most cases, a bone fracture is easily diagnosed by a doctor during a physical examination or X-ray. In some cases, especially wrist fractures or hip fractures in older patients, an X-ray does not show a bone fracture.
Broken bones heal by themselves, but they must be set in the correct place and immobilized with a cast, splint, or traction. In some cases, patients must have surgery to line the bone correctly. Most patients take painkillers and/or antibiotics to reduce the risk of infection.
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