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FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis
Date:11/14/2007

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Information about FORTEO(R)

As part of drug testing, teriparatide, the active ingredient in FORTEO(R), was given to rats for a significant part of their lifetime. In these studies, teriparatide caused some rats to develop osteosarcoma, a bone cancer. Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occurs in about four out of every million older adults each year. It is not known if humans treated with FORTEO also have a higher chance of getting osteosarcoma.

FORTEO should be prescribed only to patients for whom the potential benefits are considered to outweigh the potential risk. The drug should not be prescribed for patients at increased baseline risk for osteosarcoma, including patients with 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 FORTEO. Patients with high levels of calcium in their blood should not receive FORTEO 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 (mcg) dose approved for marketing were mild, similar to placebo and generally did not require discontinuation of therapy. Reported adverse events that appeared to be increased by FORTEO treatment were leg cramps and dizziness (2.6 and 8 percent, respectively), compared with placebo (1.3 percent and 5.4 percent, respectively).

FORTEO is supplied in a disposable pen device that can be used for up to 28 days to give once-daily self-administered injections. FORTEO is available in a 20-mcg dose and should be taken for a period of up to 24 month
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SOURCE Eli Lilly and Company
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