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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Denosumab (Prolia) – Is Another Osteoporosis Drug Causing Femur Fractures?

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Prolia, an osteoporosis drug, may be causing patients more harm than good. In a “Worst Pills Best Pills” newsletter this past June, the drug was linked to atypical fractures of the femur, causing safety concerns throughout the industry.

Approved by the FDA, Prolia was the first drug of its kind to be used in treatment of post-menopausal osteoporosis.

Although approval came in 2010, serious safety concerns had arisen a year prior, in 2009, with an FDA advisory committee meeting ultimately acting as the catalyst to clinical trials where it was determined that the medication actually led to an increased number of complications in patients, including new and increasing fractures. In fact, throughout the years of testing, new, previously unrecognized fractures began to develop in patients, amounting to a threefold increase in the group taking the medication, compared to a 1.6-fold increase in those taking the placebo.

After the tests, the FDA’s Division of Epidemiology listed nine “adverse events of special interest” linked to the drug:

• Osteonecrosis of the jaw;
• Atypical fracture;
• Fracture healing complications;
• Hypocalcemia leading to hospitalization or emergency room (ER) visit;
• Infections leading to hospitalization or ER visit;
• Dermatologic adverse events leading to hospitalization or ER visit;
• Acute pancreatitis leading to hospitalization;
• Hypersensitivity reactions leading to hospitalization or ER visit; and
• New primary malignancy.

With the occurrence of atypical fractures, physicians around the world are being warned against prescription of the medication. No US physicians have received warnings.