Bisphosphonate-related osteonecrosis of the jaw: an Italian post-marketing surveillance analysis. (September 2014)

• Record Type: Journal Article
• Authors: Parretta, Elisabetta; Sottosanti, Laura; Sportiello, Liberata; Rafaniello, Concetta; Potenza, Simona; D'Amato, Salvatore; González-González, Rocio; Rossi, Francesco; Colella, Giuseppe; Capuano, Annalisa
• Is Part Of: Expert opinion on drug safety. Volume 13:Number 1(2014:Jan.)
• Page Start: 31
• Page End: 40
• Publication Date: 2014-09
• Subjects: Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1517/14740338.2014.951329
• Languages: English
• ISSNs: 1474-0338

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <bold> <italic>Objective:</italic> </bold> Although bisphosphonate (BP)-related osteonecrosis of the jaw (BRONJ) is well recognized, little is known about it in terms of pathophysiology, epidemiology or management. We analyzed all suspected BRONJ reports sent to the Italian Pharmacovigilance Adverse Event Spontaneous Reporting System (<italic>Rete Nazionale Farmacovigilanza</italic> [RNF]) to determine their pattern and add new information about this relevant issue.</p> <p> <bold> <italic>Research design and methods:</italic> </bold> All suspected BRONJ sent to the RNF between 2003 and 2011 were retrieved. After a case-by-case assessment procedure, we analyzed BP type, BP exposure time and time since last use.</p> <p> <bold> <italic>Results:</italic> </bold> Between 2003 and 2011, 555 reports of osteonecrosis of the jaw (ONJ) after BP administration were recorded in the RNF. These events occurred mostly in patients affected by cancer (77.84%) in which zoledronate was the most frequently suspected BP. Most patients experienced ONJ after long-term use of the drug (median time of BP exposure being between 1.3 and 8.8 years). Interestingly, 139 (25.05%) cases of ONJ occurred between 2 and 121 months after BP withdrawal.</p> <p> <bold> <italic>Conclusion:</italic> </bold> This study shows that BRONJ can occur much earlier than hitherto reported, adds new data on BRONJ onset following ibandronate treatment and reveals that patients who cease BP-based therapy develop ONJ, raising the question of post-treatment monitoring strategies.</p> </abstract>