BLACK BOX WARNING FOR FORTEO, a gentically engineered pharmaceutical
POTENTIAL RISK OF OSTEOSARCOMA: In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20-mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe FORTEO® only for patients for whom the potential benefits are considered to outweigh the potential risk. FORTEO should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton)
Forteo, the drug that was found to cause a rare, serious bone cancer (osteosarcoma) in rodents, but drug proponents suggested such cancers would not occur in humans. But this week, there have been three reported cases of this rare bone cancer developing in people taking Forteo.
The most recent case was detailed in an abstract (# SU0345) presented at the annual meeting of the American Society for Bone Mineral Research in Denver, from which I just returned. This is the third case in the recent literature. The first case of osteosarcoma associated with Forteo use was published in the Journal of Bone Mineral Research in 2007 (JBMR vol. 22, p. 334), and a second case was published on-line in Osteoporosis International on the 14th of July, 2009.
Read more...What you can do to protect your bones-It is a myth that calcium is the cure for prevention. The best prevention is regular weight-bearing exercise, an increased intake of vitamin D-3 (at least 2,000 IU a day, more if you live in northern latitudes and are a person of color or someone who does not go in the sun), vitamins K and C, magnesium, and a high intake of vegetables (especially leafy green and yellow vegetables). A study reported in the American Journal of Clinical Nutrition found that the best preventative against osteoporosis is a high intake of vegetables, both because of the high potassium content and the fact that a number of flavonoids in vegetables directly prevent calcium loss. In addition, avoiding a high intake of red meats is also essential.Bone Health Testing - Better than DEXA and no radiation exposure Bone Density Measurements: Most people think of bone density studies as involving special x-ray machines. In fact, better measurements can be obtained from blood tests. One of the best involves measurements of pyridinium crosslinks and deoxypridinoline (DPD).
Pyridinium is a substance found in both bone and cartilage and deoxypyridinoline is found predominantly in bone. High levels of DPD indicate osteoporosis when other bone disorders are not present.
Pyridinium is elevated in a number of conditions including osteoporosis, rheumatoid arthritis, osteoarthritis and chronic alcohol abuse. These tests are very valuable in following responses to treatments.
And when getting annual physicals, make sure to request a Phosphorus level so you can determine the Calcium-Phosphorus ratio. Years ago Phosphorus was removed from the metabolic panel by Medicare because they believed it to be a cost cutting measure and an unnecessary test.
You might also consider testing for vitamin D (25 OH test) and parathyroid hormone.
Thank you to Susan Brown PhD and Russell Blaylock MD for sharing some of the information in this post.
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