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2011-10-31

Bisphosphonates Linked to Kidney Damage & Death

Happy Halloween!
Osteoporotic fractures are a significant cause of disability and healthcare expenditures from postmenopausal women. The most commonly used drugs for osteoporosis are bisphosphonates, which inhibit cells called osteoclasts from breaking-down bone (a normal and necessary part of bone health, just not so good if the osteoblasts, the bone-building cells, are not as active).

Orally administered bisphosphonates (like alendronate and risedronate) have been shown to reduce osteoporotic non-vertebral and hip fractures, but adherence/compliance is poor.

Zoledronic acid is an injectable bisphosphonate administered every 1-2 years, which improves compliance.

However, zoledronic acid (brand name, Reclast), is now contraindicated for patients with low kidney function, according to a label change announced last week by the US FDA. The revision, comes in the wake of continued cases of fatal acute renal failure associated with the drug.

Patients who take zoledronic acid and have underlying moderate to severe kidney impairment are at risk for kidney failure — a rare adverse event — and this risk increases with age, according to the FDA. Other risk factors for renal failure are severe dehydration occurring before or after infusion with zoledronic acid, and concurrent use of kidney-damaging or diuretic medications

A 2009 postmarket safety review by the FDA identified 5 patients who died of acute kidney failure after being treated with zoledronic acid. Another review earlier this year identified 11 more fatal cases of acute kidney failure after zoledronic acid infusion, as well as 9 cases of kidney damage that required dialysis.

Well, there's some more guff for you on Halloween.

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