Monkeys developed tooth and jaw abscesses and two died of protozoal infections.
Human subjects developed cervical, ovarian, pancreatic, gastric and thyroid cancers and breast cancer "was the most common adverse event that led to discontinuation" in trials. Adverse effect?
Ten people were hospitalized with the skin infection cellulitis during trials and one died.
But the FDA approved Amgen's Prolia (denosumab) this month to prevent fractures in women with osteoporosis, two months earlier than expected. And with Amgen consultants sitting unabashedly on the Advisory Committee for Reproductive Health Drugs.
Prolia is not your grandmother's bone prep. Unlike old fashioned "small molecules" made from chemicals, it is a "monoclonal antibody" derived from genetically engineered Chinese hamster ovary cells that inhibits a protein, RANKL, which causes bone loss.
Twenty-seven similar monoclonal antibody products (MoAbs), which treat serious conditions like cancer and autoimmune disease, have been approved by the FDA. Twenty have Black Box Warnings because of their side effects like opportunistic infections which occur when the immune system is oppressed, anaphylaxis and malignancies.
Already, Thousand Oaks, CA-based Amgen has deployed 1,000 reps across its "bone health, inflammation and hospital teams" to call on a "large number of physicians including specialists and primary care physicians who treat postmenopausal osteoporosis," says Medical Marketing and Media. Follow the tote bags.
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