Journal of Pharmacovigilance

Evaluation of drugs removed from the United States market from 2000 to 2015

6^th Pharmacovigilance Congress

September 28-30, 2016 Toronto, Canada

Ramie Fathy

South College School of Pharmacy, Knoxville, TN

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

This study was conducted to collect and analyze data on prescription drugs removed from the United States market from 2000 to 2015. Information was initially obtained from the FDA website and then augmented with data from primary literature. Medline was the primary bibliographic database utilized with withdrawn drug names as keywords. Inquiry was also done on drugs that were later reinstated and drugs that only had a single dosage form removed from the market. A total of 26 drugs were withdrawn from the market during the time period researched. Three drugs were withdrawn then reinstated and 5 drugs had a certain dosage form withdrawn. The top 3 drug classes removed were: Biological response modifiers (19.2%), gastrointestinal agents (15.3%) and psychotropic agents (15.3%). The top three reasons drugs were withdrawn from the market were cardiotoxicity, hepatotoxicity and stroke. Of the agents withdrawn, the average time on the market was 9.0 years +/- 6.2. The median and mode were 8.5 and 4.0 years respectively. These were calculated removing the outliers which are propoxyphene (52.0 years) and pemoline (30.3 years). It appears that the top classes of drugs withdrawn from the market and the reasons for removal have changed in the past 13 years as compared to earlier findings by others. Reported prolonged periods of drugs in the market before removal may necessitate a strict monitoring of both efficacy and toxicity once drugs are approved.

Biography :

Email: ghussein@southcollegetn.edu