Global Drug Safety Insights From Taiwan.

Abstract

The investments made by the government of Taiwan to create the Taiwan National Health Insurance Research Database continue to realize global population health benefits. The database has been used to conduct numerous studies of drug safety and efficacy, diagnostic test utility, disease progression, and risk factor prognosis, generating important clinical and public health insights thathave implicationsnotonly for thepeopleofTaiwan but also for people around theworld.1 The article by Lee et al2 on fluoroquinolone safety in this issueof JAMA InternalMedicine adds to this knowledge. Fluoroquinolones are among the most widely used antibiotics in theworld becauseof broadgram-positive andgramnegative coverage, excellent oral bioavailablity, and, thus far, manageable resistance patterns. More than 20 million individuals receivedanoutpatientprescription in theUnitedStates in 2011 alone, nearly 4 million in the hospital setting.3 However, despite being generally well tolerated, rare serious adverseeffectshavebeenreported,andthere isaclass-levelblack boxUSdrug labelwarningof an increased riskof tendinitis and tendon rupture, possibly secondary to the fluoroquinolones’ effectoncollagen,andofmuscleweaknessexacerbation inpersons with myasthenia gravis. Using case-control methods to analyze the Taiwan National Health Insurance Research Database, Lee et al2 examine a related, and serious though rare, collagen-based drug safetyconcern:aorticaneurysmanddissection, findinganearly 3-fold increased riskof aortic aneurysmanddissectionamong fluoroquinolone users. Risk for this serious yet rare adverse event should be considered in any benefit-risk calculation for fluoroquinolone use, and further research into the impact of these important antibiotics effect on collagen is needed.However, physicians andotherhealth careprofessionals shouldbe aware of this potential risk so that they can act swiftly to address aortic aneurysms and dissections when they do occur.