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A letter to the New England Journal of Medicine noted that since the initial marketing of Fosamax, known generically as alendronate, the FDA has received twenty-three reports in which patients developed esophageal tumors. The report has now been expanded to include more than forty reported cases of esophageal cancer and fourteen deaths.
Esophagitis, which is an inflammation of the lining of the tube carrying food to the stomach, is already a known side effect of the drugs, which is why patients are instructed to remain upright for at least a half hour after taking them. The ever-expanding list of side effects linked to bisphosphonates includes osteonecrosis, severe bone and joint pain, sudden low energy leg fractures, and irregular heart rhythms.
"The fact that these drugs deposit in the bone suggests that patients may risk experiencing one or more of these conditions many years after bisphosphonate therapy is stopped," says Warren Levy, PhD, CEO of Unigene Laboratories, a biopharmaceutical company focused on peptide-based nasally and orally delivered osteoporosis treatments.
"For the millions of people who have taken or are considering taking these drugs, it is essential that patients are made aware of new potential long-term safety issues before selecting an osteoporosis treatment," said Dr. Levy.
One option is calcitonin, the active ingredient in drugs used for more than 35 years to treat osteoporosis with virtually no significant side effects. This is presumably due to the fact that calcitonin is a naturally-occuring hormone found in humans and many other animals. Calcitonin-based products, which include prescription therapeutics such as Fortical(R) from Upsher Smith Laboratories, can be taken by patients with other medications. Nasal calcitonin products have been shown to decrease fracture risk by 40 to 60% and also help maintain proper bone density.
Moreover, calcitonin is rapidly cleared from the body and restores bone resorption to pre-osteoporotic levels, preserving bone micro-architecture. An estimated ten million Americans, mostly women, have osteoporosis. For more information, log on to www.unigene.com.
SOURCE: Unigene Laboratories
IRG Janet Vasquez, 212-825-3210
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