November 14, 2012 — In the latest issue of Best Pills, Worst Pills, the consumer advocacy group Public Citizen is warning that manufacturers of Xgeva and Prolia (denosumab) have not warned American consumers about the risk of deadly low calcium levels (hypocalcemia), despite the fact that this side effect has caused multiple deaths.
Furthermore, European and Canadian health regulators have issued warnings, but the U.S. Food and Drug Administration (FDA) has not warned about the risk.
Unfortunately, some physicians and patients taking Xgeva and Prolia may not be aware about the risk of hypocalcemia (dangerously low calcium levels), which can trigger seizures, irregular heart rhythm, and death. Public Citizen recommended that patients who are taking these drugs should consult their physician about the risk of hypocalcemia.
Xgeva (120-mg of denosumab) and Prolia (60-mg of denosumab) are injection medications used to treat bone-loss. Xgeva is administered once every 4 weeks to treat patients with bone cancer. Prolia is administered once every 6 months to treat patients with osteoporosis (chronic loss of bone density associated with bone fractures).
Unfortunately, three deaths have been linked to Xgeva induced hypocalcemia. Serious injuries have also been reported with Prolia, but no deaths.
In response to the injuries and deaths, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) published recommendations that doctors should check patients for pre-existing hypocalcemia before they prescribe Xgeva or Prolia. Furthermore, as a preventative measure, the MHRA recommended prescribing calcium and Vitamin D supplements for patients on these drugs, unless the patient has dangerously high calcium levels.
Health officials in Canada have also published a safety communication. They warned that hypocalcemia was most likely to occur in patients who were just starting the drugs, in the first 6 months of treatment. Patients with poor kidney function were also more likely to suffer from hypocalcemia.