FORTEO – FDA approves new drug indication for Forteo
On July 23, Eli Lilly and Company announced that the Food and Drug Administration (FDA) has approved a new use for its osteoporosis drug Forteo (teriparatide) to treat osteoporosis associated with sustained, systemic glucocorticoid therapy in men and women at high risk of fracture. Glucocorticoid therapy is the most common cause of secondary osteoporosis, leading to bone loss and an increased risk for fracture, according to a statement from Eli Lilly. Glucocorticoid-induced osteoporosis, or GIO, is associated with chronic use of glucocorticoid medications, which are often prescribed for inflammatory conditions such as rheumatoid arthritis and obstructive pulmonary disease. Data indicate that glucocorticoid medications are used by up to three out of every 100 adults over age 50.
Approximately 50 percent of individuals who are prescribed chronic glucocorticoid therapy will eventually have an osteoporotic fracture. The use of glucocorticoid medications can lead to a reduction in bone formation, the company said. Forteo has been shown to counter this effect by stimulating bone formation.
In the course of the FDA’s review of the new indication, Lilly provided data from a clinical study which showed that in patients with glucocorticoid-induced osteoporosis, Forteo increased bone mineral density (BMD) from baseline to 18 months of treatment by 7.2 percent at the lumbar spine, 3.6 percent at the total hip, and 3.7 percent at the femoral neck.
“Until now, physicians and patients had only one class of approved therapy for the treatment of glucocorticoid-induced osteoporosis,†said Kenneth G. Saag, MD, MSc, professor of medicine and epidemiology at the University of Alabama in Birmingham. “The approval of teriparatide for this new indication offers healthcare providers and patients a new treatment option that effectively increases bone mineral density in a different way than anti-resorptives.â€
FORTEO – FDA approves new drug indication for Forteo
August 5th, 2009 at 11:02 am
What is Forteo?
Feedback for Forteo
Forteo is a man-made form of a hormone called parathyroid that exists naturally in the body. Forteo increases bone density and increases bone strength to help prevent fractures.
Forteo is used to treat osteoporosis in men and women who have a high risk of bone fracture.
Forteo may also be used for other purposes not listed in this medication guide.
August 5th, 2009 at 11:02 am
What is the most important information I should know about Forteo?
This medication has been found to cause an increased risk of bone cancer in animal studies. It is not known if this risk is also increased in humans treated with Forteo. Talk with your doctor about your individual risk.
Forteo can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid smoking cigarettes, or try to quit smoking altogether. Smoking can reduce your bone mineral density, making fractures more likely. Avoid drinking alcohol, which also may affect your bone mineral density.
August 5th, 2009 at 11:03 am
What should I discuss with my healthcare provider before using Forteo?
Do not use this medication if you are allergic to teriparatide.
Before using Forteo, tell your doctor if you are allergic to any drugs, or if you have:
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Paget’s disease or other bone disorders (besides osteoporosis);
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high levels of calcium or alkaline phosphatase in your blood;
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a condition called hyperparathyroidism;
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a bone disease other than osteoporosis;
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a history of bone cancer or radiation treatment involving your bones; or
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if you have ever had kidney stones.
If you have any of these conditions, you may need a dose adjustment or special tests to safely use Forteo.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Forteo passes into breast milk. Do not use Forteo without telling your doctor if you are breast-feeding a baby.
This medication has been found to cause an increased risk of bone cancer in animal studies. It is not known if this risk is also increased in humans treated with Forteo. Talk with your doctor about your individual risk.