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Prolia LInked to Serious Adverse Events in FDA Reporting System

Raleigh, NC: According to a study published at a medical meeting this week in North Carolina, more than 40 serious cutaneous adverse events linked to the osteoporosis formulation of Prolia (denosumab) were discovered in a review of FDA records. Nine of the people who suffered adverse events required hospitalization.

The adverse events, reported in the FDA Adverse Event Reporting Systems (AERS) include angioedema, cellulitis, and pustular dermatitis. Dr. Beatrice Nardone, MD, of Northwestern University in Chicago presented the data at the annual meeting of the Society for Investigative Dermatology. She noted that most of adverse events were limited to the denosumab formulation for post-menopausal osteoporosis osteoporosis, Prolia 60 mg every six months, and not the formulation used to treat, cancer-induced bone disease, which is higher at 120 mg every 4 weeks.

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Last updated on May-15-12

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