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The U.S. Meals and Drug Administration (FDA) has issued a black field warning — reserved for essentially the most severe issues of safety — for the osteoporosis drug denosumab, bought underneath the model identify Prolia.
Sufferers with superior power kidney illness run the danger of extreme hypocalcemia — dangerously low blood calcium ranges that may trigger life-threatening unintended effects like seizures and coronary heart failure — once they take denosumab, the FDA mentioned in a January 19 assertion.
“For sufferers with superior kidney illness, particularly these on dialysis handled with Prolia, frequent monitoring of calcium within the blood, particularly for the primary 2 to 10 weeks after every Prolia injection, is beneficial,” the FDA mentioned within the assertion.
Signs that may point out extreme hypocalcemia embody confusion, seizures, fainting, face twitching, uncontrollable muscle spasms, tingling or numbness in components of the physique, or an irregular coronary heart rhythm, in line with the FDA. Folks taking denosumab who expertise these signs ought to contact their healthcare supplier — particularly if they’ve power kidney illness or are on dialysis, the FDA mentioned.
“Speak to your healthcare skilled about particular directions for the dose and sort of calcium and vitamin D dietary supplements that could be wanted,” the FDA mentioned. “Don’t cease taking Prolia with out speaking together with your healthcare skilled, as your danger of bone fracture, together with within the backbone, is elevated after stopping, skipping, or delaying Prolia.”
Security Dangers With Denosumab
Based mostly on an evaluation of research accomplished primarily in Medicare sufferers taking denosumab, the FDA recognized a considerably elevated danger of hypocalcemia in folks taking this drug, as in contrast with one other household of osteoporosis medication generally known as bisphosphonates.
Regulators additionally reviewed 25 instances of power kidney illness sufferers, together with a number of folks on dialysis, who skilled problems of extreme hypocalcemia after beginning remedy with denosumab, the FDA mentioned. These points included coronary heart rhythm irregularities in addition to confusion, seizures, face twitching, and muscle spasms or weak point.
A examine of dialysis sufferers with osteoporosis printed in JAMA on January 19 additionally recognized a considerably elevated danger of extreme hypoglycemia in 1,523 folks on denosumab, in contrast with 1,281 people taking bisphosphonates.
Over the primary 12 weeks of remedy, about 41 % of denosumab sufferers skilled extreme hypocalcemia, in contrast with 2 % on bisphosphonates, the examine discovered. That interprets into a couple of 20 occasions better danger with denosumab.
Lowering Fracture Danger
One problem folks with extreme power kidney illness face in figuring out whether or not denosumab is well worth the danger is that this drug, like different osteoporosis medicines, hasn’t been confirmed to forestall fractures, says Thomas Nickolas, MD, a professor of nephrology at Columbia College Irving Medical Middle in New York Metropolis.
“There are medical trials which have proven these medicines will enhance bone mineral density, which we assume interprets into safety towards fractures,” Dr. Nickolas says. However because the profit isn’t confirmed, there are different medicines for osteoporosis folks can take that don’t have the identical danger of extreme hypocalcemia.
Past this, there are a number of issues folks can do with out taking medicines that may assist to promote bone well being and reduce the danger of fractures, Nickolas says. Folks with superior power kidney illness and people on dialysis ought to take the identical steps as people with out these situations.
“For instance, a nutritious diet with enough protein consumption, weight-bearing train, limiting alcohol consumption, and avoiding tobacco are universally good for the skeleton,” Nickolas says.
“Avoiding falls can also be crucial, and I counsel all my sufferers on fall prevention, together with having night time lights round the home, ensuring rugs should not free, ensuring to decelerate in the event that they really feel dizzy when going from sitting or mendacity to standing, and limiting publicity to medicines that trigger falls.”
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