Service de Pharmacologie Médicale et Clinique, Centre de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, INSERM U1027, Faculté de Médecine, Centre Hospitalier Universitaire, Toulouse, France.
Departamento de Medicina, Área de Farmacología, Universidad de Oviedo, Oviedo, Spain.
Eur J Clin Pharmacol. 2019 Dec;75(12):1705-1711. doi: 10.1007/s00228-019-02743-9. Epub 2019 Aug 29.
Osteomalacia and osteoporosis are two metabolic bone disorders that increase the risk of fracture due to several causes. In terms of drugs, apart from corticosteroids, which are known to induce bone disorders, several other drugs used in chronic disease management have also been linked with an increased risk of osteoporosis and osteomalacia.
The aim of this study was to describe spontaneous reports of drug-induced osteoporosis and osteomalacia in the French (FPVDB) and Spanish (SPVDB) pharmacovigilance databases.
Data were provided by the FPVDB and SPVDB. All reports of osteoporosis and osteomalacia recorded from 1985 up to 31 December 2015 inclusive were selected. Taking the time to onset of bone loss into account, all cases occurring in less than 1 month were excluded.
A total of 369 reports (44 cases of osteomalacia, 325 cases of osteoporosis) were registered in the FPVDB and 64 (22 cases of osteomalacia, 42 cases of osteoporosis) in the SPVDB. In France, the top 5 drugs involved in the onset of osteoporosis were corticosteroids accounting for approximately half of the reports (n = 170) followed by systemic antiviral (n = 87), antacid (n = 29), antiepileptic (n = 27) and antithrombotic (n = 24) drugs. The 2 main classes of drugs implicated in osteomalacia were systemic antiretroviral drugs for half of the reports (n = 21) and antiepileptic drugs (n = 15). In Spain, corticosteroids were involved in 35.7% of reported cases of osteoporosis (n = 15) followed by systemic antiviral drugs (n = 12). There was no spontaneous report for antacid drugs. For osteomalacia, the 2 main drug classes were systemic antiretroviral drugs (n = 18, 81.8%) followed by antiepileptics (n = 2, 9.0%). In both countries, concomitant administration of systemic corticosteroids with other suspected drugs did not significantly modify the time to onset of drug-induced osteoporosis.
Despite some differences between the French and Spanish PVDBs, our data consistently show that bone loss is not only restricted to glucocorticoids but also involves antivirals, antiepileptic drugs, antacid drugs or antidepressants. Further analysis might prove useful in exploring the characteristics of drug-induced bone loss on a larger scale.
骨软化症和骨质疏松症是两种代谢性骨病，由于多种原因会增加骨折的风险。就药物而言，除了已知会引起骨疾病的皮质类固醇外，还有其他几种用于慢性疾病管理的药物也与骨质疏松症和骨软化症的风险增加有关。
本研究旨在描述法国（FPVDB）和西班牙（SPVDB）药物警戒数据库中药物引起的骨质疏松症和骨软化症的自发报告。
数据由 FPVDB 和 SPVDB 提供。从 1985 年到 2015 年 12 月 31 日，所有记录的骨质疏松症和骨软化症报告均被选择。考虑到骨丢失的发生时间，所有在 1 个月内发生的病例均被排除。
在 FPVDB 中注册了 369 份报告（44 份骨软化症，325 份骨质疏松症），在 SPVDB 中注册了 64 份报告（22 份骨软化症，42 份骨质疏松症）。在法国，导致骨质疏松症发病的前 5 种药物是皮质类固醇，约占报告的一半（n=170），其次是全身性抗病毒药物（n=87）、抗酸剂（n=29）、抗癫痫药物（n=27）和抗血栓形成药物（n=24）。与骨软化症有关的 2 种主要药物类别是全身性抗逆转录病毒药物，占报告病例的一半（n=21），其次是抗癫痫药物（n=15）。在西班牙，皮质类固醇占报告骨质疏松症病例的 35.7%（n=15），其次是全身性抗病毒药物（n=12）。没有抗酸剂药物的自发报告。对于骨软化症，2 种主要药物类别是全身性抗逆转录病毒药物（n=18，81.8%），其次是抗癫痫药物（n=2，9.0%）。在这两个国家，全身性皮质类固醇与其他可疑药物联合使用并不会显著改变药物引起骨质疏松症的发病时间。
尽管法国和西班牙的 PVDB 之间存在一些差异，但我们的数据一致表明，骨质流失不仅限于糖皮质激素，还涉及抗病毒药物、抗癫痫药物、抗酸药物或抗抑郁药。进一步的分析可能有助于在更大范围内探索药物引起的骨丢失的特征。
