Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity
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Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity Issuing labding changes is a common pmcticc to nwn about important side cffeds afier cfrug appmd. Among the rmmy safety concerns, liver taxicity is jkquen@ a major cause for p a t a p p d labding changes. To examine labding changes associated with liver taxicity, safe@-dated labdingchangesdue to liver taxicity were reviewed. h9 were cutego?ized into labding changes that dm$ed/anphasizt?d existing s a f e infonnatiosl and those that added new safety information. For labeling changes with new safety i n f m k m , the praqppraval safety data were m'ewed to evaluate whether then was strong evidenceof liver taxicity in the pnappmvcddinical data. Ibirfyjbe labding changes were f m d to meed the sdcction aituia Among than, 10
Key Words Label; Liver toxicity; Warning Correspondence Address Yeong-Liang Lin, Center for Drug Evaluation I E No. IS- I , Section I , Hangjou S Road, Taipei, Taiwan I00 (e-mail: yllin @cde. org. tw).
INTRODUCTION Drug labels are used to provide scientific evidence and data acquired during drug development. They are based on data from adequate and well-controlled studies under acceptable standards. After new drugs are approved, with more efficacy and safety information becoming available, drug labels are revised to accommodate the new efficacy and safety information. Although there is some evidence that adding warnings to drug labels can occasionally change the prescribing behavior, for example, dramatic changes were noted in the emergency department use of droperidol after the black box warning was added, several studies demonstrate that drug labeling changes, including black box warning, have no measurable effect on compliance with the labeling recommendations (1-4). Some experts considered using the black box warning as a safety tool, which can be associated with controversial issues. It can lead to unwar-
emphasized existing infmation and eight added new information on liver taxicity. he me 'w of the pnappmal safety data of drugs with labding changes that added new inf d h on liver toxicity demonstrated that only seven eventsof mild liver tmkity were associated with atomaxetine, and for telithromycin, the mtes of combined elevation of bilirubin and mnin-m and of pure elevation of mninotmmfetuseswere mmpadle with the COmpamtoK In condusion, after Sryg approval, labeling changes are occasion@ issued to warn of liver taxis@ h9 dmi&emphasized existing liver taxicity information more often than added new infonnation. For drugs not considered hepatotaxic initial&but found to be associated with significantliver tmkity concern after drug qpproval, no strong evidence of liver taxicity could be noted in the ppproval data sets.
ranted litigation and unnecessary change from a well-established, safe, and less costly drug to one of lesser safety (5). How to use labeling changes appropriately to improve the safe use of new drugs is an issue worth addressing. The purpose of the present study is to examine labeling
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