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Zoledronic acid (Reclast) prescribing information to list renal dysfunction as contraindication
FDA is requiring the zoledronic acid (Reclast, Novartis) prescribing information to now include a warning not to use the drug in those with renal dysfunction.
Key Points
FDA is requiring the zoledronic acid (Reclast, Novartis ) prescribing information to now include a warning not to use the drug in those with renal dysfunction. Specifically, the revised label lists a creatinine clearance less than 35 mL/min or evidence of acute renal impairment as contraindications to Reclast use. The revised label will also recommend providers monitor serum creatinine prior to administering Reclast, and that they continue to do so after patients have received the drug.
This labeling change was announced in an on-line FDA drug safety communication released on September 1, 2011. According to FDA officials, the revised label, "...will enhance the safe use of Reclast by providing healthcare professionals updated instructions for prescribing and patient monitoring."
When marketed as Reclast, zoledronic acid is used to treat or prevent osteoporosis in women after menopause, to increase bone mass in men with osteoporosis, to treat Paget's disease in men and women, and to prevent steroid-induced osteoporosis in men and women. Reclast is administered as a single intravenous dose once every 1 to 2 years, depending on the indication.
Of note, these revisions only apply to the Reclast, and not Zometa label, the name zoledronic acid is marketed under when used for cancer-related indications, FDA noted, "Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa label as well as in the Reclast label." Dose reductions for Zometa are required for patients with renal impairment.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
