Drug Security Communication (PDF – 166 KB)

11-22-2022 FDA Drug Security Communication

The U.S. Meals and Drug Administration (FDA) is investigating the chance of extreme hypocalcemia with severe outcomes, together with hospitalization and dying, in sufferers with superior kidney illness on dialysis handled with the osteoporosis medication Prolia (denosumab). Our evaluation of interim outcomes from an ongoing security research of Prolia suggests an elevated danger of hypocalcemia, or low calcium ranges within the blood, in sufferers with superior kidney illness. Preliminary outcomes from a separate inside FDA research additional investigating hypocalcemia in dialysis sufferers handled with Prolia present a considerable danger with severe outcomes, together with hospitalization and dying.

Due to the frequency and seriousness of those dangers, we’re alerting well being care professionals and sufferers about them and that we’re persevering with to guage this potential security concern with Prolia use in sufferers with superior kidney illness, notably these on dialysis. We’ll talk our closing conclusions and proposals when we’ve got accomplished our evaluation or have extra info to share.

Sufferers mustn’t cease Prolia therapy with out first consulting your well being care skilled, as stopping might worsen your bone situation. Speak to your well being care skilled about any considerations you will have, together with doable various therapies. Inform your well being care skilled for those who expertise any signs of low blood calcium ranges akin to uncommon tingling or numbness within the palms, arms, legs, or toes; painful muscle spasms or cramps; voice field or lung spasms inflicting problem respiratory; vomiting; seizures; or irregular coronary heart rhythm.

Well being care professionals ought to think about the dangers of hypocalcemia with using Prolia in sufferers on dialysis. When Prolia is utilized in these sufferers, enough calcium and vitamin D supplementation and frequent blood calcium monitoring, presumably extra usually than is already being performed, might assist lower the probability or severity of those dangers. Advise sufferers on dialysis to right away search assist in the event that they expertise signs of hypocalcemia.

Prolia is a prescription medication authorised in June 2010 to deal with postmenopausal ladies with osteoporosis at excessive danger for bone fracture. Prolia was later authorised to deal with males with osteoporosis, glucocorticoid induced osteoporosis, bone loss in males receiving androgen deprivation remedy for prostate most cancers and in ladies receiving aromatase inhibitor remedy for breast most cancers. Prolia works by blocking a protein referred to as RANK (receptor activator of nuclear issue kappa beta) and helps stop bone cells referred to as osteoclasts from breaking down bone within the physique. A well being care skilled administers Prolia by injection as soon as each six months.

When FDA first authorised Prolia, we required the producer, Amgen, to conduct a long-term security research in ladies with postmenopausal osteoporosis and males with osteoporosis. Our evaluation of the interim outcomes from this ongoing security research suggests an elevated danger of hypocalcemia with Prolia in sufferers with superior kidney illness. As well as, hostile occasion experiences submitted to FDA confirmed extreme and symptomatic hypocalcemia, together with hospitalization and dying, is going on in sufferers with superior kidney illness handled with Prolia. Preliminary outcomes from a separate inside FDA research investigating the chance of hypocalcemia counsel that sufferers on dialysis handled with Prolia are at substantial danger for extreme and symptomatic hypocalcemia, together with hospitalization and dying.

We urge well being care professionals and sufferers to report unwanted side effects involving Prolia or different medicines to the FDA MedWatch program, utilizing the knowledge within the “Contact FDA” field on the backside of the web page.

Well being care professionals, sufferers, and customers can join electronic mail alerts about Drug Security Communications on medicines or medical specialties of curiosity to you.

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