FDA Issues Boxed Warning For Osteoporosis Drug Prolia
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The U.S. Food and Drug Administration (FDA) has issued a black box warning — reserved for the most serious safety issues — for the osteoporosis drug denosumab, sold under the brand name Prolia.
Patients with advanced chronic kidney disease run the risk of severe hypocalcemia — dangerously low blood calcium levels that can cause life-threatening side effects like seizures and heart failure — when they take denosumab, the FDA said in a January 19 statement.
“For patients with advanced kidney disease, especially those on dialysis treated with Prolia, frequent monitoring of calcium in the blood, especially for the first 2 to 10 weeks after each Prolia injection, is recommended,” the FDA said in the statement.
Symptoms that might indicate severe hypocalcemia include confusion, seizures, fainting, face twitching, uncontrollable muscle spasms, tingling or numbness in parts of the body, or an irregular heart rhythm, according to the FDA. People taking denosumab who experience these symptoms should contact their healthcare provider — especially if they have chronic kidney disease or are on dialysis, the FDA said.
“Talk to your healthcare professional about specific instructions for the dose and type of calcium and vitamin D supplements that may be needed,” the FDA said. “Do not stop taking Prolia without talking with your healthcare professional, as your risk of bone fracture, including in the spine, is increased after stopping, skipping, or delaying Prolia.”
Safety Risks With Denosumab
Based on an analysis of studies done primarily in Medicare patients taking denosumab, the FDA identified a significantly increased risk of hypocalcemia in people taking this drug, as compared with another family of osteoporosis drugs known as bisphosphonates.
Regulators also reviewed 25 cases of chronic kidney disease patients, including several people on dialysis, who experienced complications of severe hypocalcemia after starting treatment with denosumab, the FDA said. These issues included heart rhythm irregularities as well as confusion, seizures, face twitching, and muscle spasms or weakness.
A study of dialysis patients with osteoporosis published in JAMA on January 19 also identified a significantly increased risk of severe hypoglycemia in 1,523 people on denosumab, compared with 1,281 individuals taking bisphosphonates.
Over the first 12 weeks of treatment, about 41 percent of denosumab patients experienced severe hypocalcemia, compared with 2 percent on bisphosphonates, the study found. That translates into about a 20 times greater risk with denosumab.
Reducing Fracture Risk
One challenge people with severe chronic kidney disease face in determining whether denosumab is worth the risk is that this drug, like other osteoporosis medicines, hasn’t been proven to prevent fractures, says Thomas Nickolas, MD, a professor of nephrology at Columbia University Irving Medical Center in New York City.
“There are clinical trials that have shown these medications will improve bone mineral density, which we assume translates into protection against fractures,” Dr. Nickolas says. But since the benefit isn’t proven, there are other medicines for osteoporosis people can take that don’t have the same risk of severe hypocalcemia.
Beyond this, there are a variety of things people can do without taking medications that can help to promote bone health and minimize the risk of fractures, Nickolas says. People with advanced chronic kidney disease and those on dialysis should take the same steps as individuals without these conditions.
“For example, a healthy diet with adequate protein intake, weight-bearing exercise, limiting alcohol intake, and avoiding tobacco are universally good for the skeleton,” Nickolas says.
“Avoiding falls is also very important, and I counsel all my patients on fall prevention, including having night lights around the house, making sure rugs are not loose, making sure to slow down if they feel dizzy when going from sitting or lying to standing, and limiting exposure to medications that cause falls.”
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