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ar disordersUncommon: Hypertension, hypotensionRare: BradycardiaRenal and urinary disordersCommon: Renal impairmentUncommon: Acute renal failure, haematuria, proteinuriaImmune system disordersUncommon: Hypersensitivity reactionRare: Angioneurotic oedemaGeneral disorders and administration site conditionsCommon: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)Uncommon: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increaseLaboratory abnormalitiesVery Common: HypophosphataemiaCommon: Blood creatinine and blood urea increased, hypocalcaemiaUncommon: Hypomagnesaemia, hypokalaemiaRare: Hyperkalaemia, hypernatraemiaIn one 3 year, randomised, double-blind controlled trial that eva luated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively. The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively. The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with Zometa (zoledronic acid) 4 mg every 34 weeks in oncology patients. The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.Post-marketing experienceThe following adverse reactions have been reported during post-approval use of Zometa.Cases of osteonecrosis (primarily of the jaws) have been reported, predominantly in cancer patients treated with bisphosphonates, including Zometa. Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries. Osteonecrosis of the jaws has multiple documented risk factors including a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e.g. anaemia, coagulopathies, infection, pre-existing oral disease). Although causality has not been determined, it is prudent to avoid dental surgery as recovery may be prolonged.In very rare cases, the following events have been reported: hypotension leading to syncope or circulatory collapse, primarily in patients with underlying risk factors, atrial fibrillation, somnolence, bronchoconstriction, anaphylactic reaction/shock, and urticaria. Because these reports are from a population of uncertain size and are subject to confounding factors, it is difficult to assess causality and to estimate event incidence rates.
Manufacturer
Novartis
Drug Availability
(POM)
Updated
12 August 2009
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