Alert! The FDA Issued Its Strictest Warning For Deadly Effects Of Osteoporosis Drug Prolia

The Food and Drug Administration (FDA) has added its strictest warning to Amgen's osteoporosis drug Prolia (denosumab). The move comes after years of additional monitoring and testing of a known problem with the drug. The FDA has reported outcomes for Prolia users that include hospitalization and death.

We will explain the risk associated with this osteoporosis drug and what this means to Prolia users.

Black Box Warning Added To Prolia

The FDA has added a black box warning — the agency’s most severe health warning — to the prescription osteoporosis drug Prolia (denosumab). The new label warns that the drug can lead to dangerously low levels of calcium in the blood.

This condition, called hypocalcemia, is especially dangerous for people with kidney disease, which also reduces calcium levels. In people with kidney disease, the FDA found that this side effect resulted in hospitalization, life-threatening events, and in some cases death.

The FDA has warned that hypocalcemia symptoms include confusion, irregular heart rhythm, fainting, muscle spasms, and weakness advising Prolia users to watch for these dangerous side effects.

Synopsis

The FDA has added a black box warning to the label of Prolia (denosumab) warning that it can dangerously increase the risk of hypocalcemia (low blood-levels of calcium). The condition has resulted in hospitalization, life-threatening events, and in some cases death.

All About Prolia

Prolia is a monoclonal antibody administered every six months as a subcutaneous injection. It suppresses osteoclasts, the cells responsible for breaking down old and damaged bone as part of the bone remodeling process.

To do this, Prolia mimics a tumor necrosis factor (TNF) cytokine named osteoprotegerin. Osteoprotegerin blocks the function of RANK Ligands (RANKL). RANKL is a protein that activates osteoclasts and converts osteomorphs (retired osteoclasts) back into active osteoclasts. By blocking the effects of RANKL Prolia inhibits osteoclast function and formation.

The resulting accumulation of old, damaged bone leads to an increase in bone density. However, as Savers are aware, our bones are much healthier when they can complete their bone remodeling process supported by a drug-free, bone-healthy lifestyle.

When Prolia was first approved by the FDA 14 years ago, it already carried a warning for hypocalcemia, but the FDA required Amgen to conduct additional clinical testing to further assess safety.

The agency delayed issuing a stricter warning until it reviewed studies conducted by the Centers for Medicare & Medicaid Services. Evidently, a number of people died during this process as a result of hypocalcemia linked to Prolia and kidney disease.

In a decision characteristic of the FDA, rather than removing this hazardous drug from the market, it issued an advisory that patients taking Prolia should maintain adequate calcium and vitamin D intake. For patients with advanced kidney disease, the FDA advised frequent monitoring of calcium levels in the blood.

Amgen, the Big Pharma company responsible for Prolia, earned $2.9 billion in revenue selling the drug in the nine months ending Sept. 30 of this year. As usual, the FDA and Big Pharma seem to put profits over the safety of consumers.

Synopsis

Prolia is an injectable drug made by Amgen, approved by the FDA 14 years ago. It blocks RANKL proteins by imitating a RANKL inhibitor called osteoprotegerin. RANKL inhibition results in suppression of osteoclast function and formation, leading to an increase in bone density.

How To Avoid Hypocalcemia And Other Drug Side Effects

Hypocalcemia is not unique to Prolia, although Prolia was found more likely to cause the condition than older oral bisphosphonates. Many osteoporosis drugs carry black box warnings, and all of them have a list of severe negative side effects.

• Evenity (romosozumab), another injectable monoclonal antibody, can also cause hypocalcemia in people with advanced kidney disease. Evenity was given a black box warning for increasing the risk of heart attack, stroke, and related death. Other severe potential side effects include osteonecrosis of the jaw and atypical femur fracture.
• Forteo (teriparatide), an injectable drug that works by imitating parathyroid hormone, can also cause hypocalcemia. It was given a black box warning for increasing the risk of osteosarcoma (bone cancer).
• Protos, now called Aristo, (strontium ranelate), is an oral drug used in other countries, but not approved by the FDA, that has a black box warning due to increased risk of heart attack.
• Tymlos (abaloparatide), another injectable drug, has a black box warning for increasing the risk of bone cancer. It may also cause orthostatic hypotension, hypercalcemia (too much calcium in the blood), and hypercalciuria (excess calcium in the urine).
• Fosamax (Alendronic acid) is an oral drug that carries a black box warning for increasing the risk of atypical femur fractures. Other severe side effects include hypocalcemia, osteonecrosis of the jaw, severe pain, and stomach bleeding.

The best and safest way to build your bones and improve your health without the risk of potentially devastating side effects is to pursue a drug-free, all-natural approach to prevent and reverse Osteoporosis.

That's what the Osteoporosis Reversal Program is all about. It tackles bone health on multiple fronts in multiple ways.

Through simple, gradual shifts to diet, exercise, and lifestyle choices, you can build stronger bones and a more active and healthy life. And the Saver community is made up of of people who are choosing to prevent falls and fractures without drugs, and they're using scientifically proven methods to do it. You can too.

Synopsis

Many osteoporosis drugs bear black-label warnings about their severe potential side effects, including Evenity for heart attack, Forteo for bone cancer, Protos (or Aristo) for heart attack, Tymlos for bone cancer, and Fosamax for atypical femur fracture. The only way to rule out potentially devastating drug side effects is to pursue a drug-free path to preventing and reversing osteoporosis.

What This Means To You

It took the FDA 14 years to put an appropriately forceful warning on Prolia's label. Every single person who took the drug over those years did so without knowledge of the drug's true risk level. As a result, people needlessly died.

If you're taking Prolia, talk with your doctor about this new black box warning. Ironically, stopping Prolia carries its own set of risks. This is what happens: when the drug stops preventing osteomorphs from becoming osteoclasts, a flood of new osteoclasts get formed. The result is sudden bone loss and an increased risk of fracture. If you wish to stop taking medication, consult with a medical professional.

Whether you have taken osteoporosis drugs in the past, are currently using them, or are considering the best way to improve your bone health– the Osteoporosis Reversal Program can help you improve the quality and health of your bones naturally. Best of all, the only side effect is a longer, fuller, more independent life.

References

¹ https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease