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FORSTEO(R) Receives Approval from the European Commission for the Treatment of Glucocorticoid-Induced Osteoporosis
Date:4/4/2008

Paget's disease of bone or unexplained elevations of alkaline phosphatase, children or growing adults, or those who have had prior external beam or implant radiation therapy involving the skeleton. Additionally, patients with bone metastases or a history of skeletal malignancies, and those with metabolic bone diseases other than osteoporosis, should not receive teriparatide. Patients with high levels of calcium in their blood should not receive teriparatide due to the possibility of increasing their blood levels of calcium.

In clinical trials, the most frequent treatment-related adverse events reported at the 20-microgram dose approved for marketing were mild, similar to placebo and generally did not require discontinuation of therapy. The most commonly reported adverse events in patients treated with teriparatide are nausea, pain in limb, headache and dizziness.

Teriparatide is supplied in a disposable pen device that can be used for up to 28 days to give once-daily self-administered injections. Teriparatide is available in a 20-microgram dose and should be taken for a period of up to 18 months. For full prescribing information, please visit http://www.lilly.co.uk.

About Osteoporosis

Osteoporosis is a debilitating disease that affects an estimated 75 million people in Europe, U.S. and Japan.(4) Osteoporosis, which means "porous bone," is a disease in which the density and quality of bone are reduced. As the bones become more porous and fragile, the risk of fracture is greatly increased. The loss of bone occurs "silently" and progressively and no symptoms are apparent until the first fracture occurs.(5)

The most common fractures associated with osteoporosis occur at the hip, spine and wrist. The incidence of these fractures, particularly at the hip and spine, increases with age in both women and men.(6) Vertebral fractures can result in serious consequences, including loss of heigh
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SOURCE Eli Lilly and Company
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