APPROVAL AND DISCONTINUATION OF SYSTEMIC ANTIBACTERIAL DRUGS IN THE US, (JANUARY 1938- JULY 2017)
Author(s)
Alqahtani SS1, Seoane-Vazquez E2, Rodriguez-Monguio R3
1Jazan University, Jazan, Saudi Arabia, 2Chapman University, Irvine, CA, USA, 3University of California, San Francisco, CA, USA
OBJECTIVES: To describe trends in approval and discontinuation of new systemic antibacterial drugs approved by the FDA in the period from January 1938 to July 2017. METHODS: Data were extracted from publicly available data on the FDA website: Drugs@FDA. The dates of approval and market status were confirmed using the Orange Book. In addition, therapeutic classes were obtained from the World Health Organization (ATC) Classification System. Descriptive statistics were used to compare trends between the approval and discontinuation of systemic antibacterials from January 1938 to July 2017. All the analyses were conducted using Microsoft Excel 2013. RESULTS: The FDA approved 153 new systemic antibacterial drugs for the treatment and/or prevention of bacterial infections in the period 1938-July 2017; 5 (3.3%) in the 1930s, 11 (7.2%) in the 1940s, 22 (14.4%) in the 1950s, 24 (15.7%) in the 1960s, 20 (13.1%) in the 1970s, 30 (19.6%) in the 1980s, 24 (15.7%) in the 1990s, 9 (5.9%) in the 2000s, and 8 (5.2%) in the 2010-July 2017. Out of 153 drugs identified, 85 (55.6%) were discontinued from US markets. The most common classes of systemic antibacterial drugs discontinued from the market were: J01D other beta-lactam antibacterials: 19 (46.3%), J01C beta-lactam antibacterials, penicillins: 18 (66.7%), J01E sulfonamides and trimethoprim: 17 (89.5%), J01M quinolone antibacterials: 12 (66.7%), J01X other antibacterials: 5 (26.3%), J01F macrolides, lincosamides and streptogramins: 5 (45.5%), J01A tetracyclines: 5 (55.6%), J01G aminoglycoside antibacterials: 3 (37.5%), and J01B amphenicols: 1 (100.0%) Of the 85 discontinuations, 8 (9.4%) were discontinued due to safety reasons. The other 77 (90.6%) were discontinued for unobservable reasons. CONCLUSIONS: More than 50% of all new systemic antibacterials approved by the FDA in the period from January 1938- July 2017 were discontinued from the market. Safety was the reason for discontinuation of one in ten drugs.
Conference/Value in Health Info
2018-05, ISPOR 2018, Baltimore, MD, USA
Value in Health, Vol. 21, S1 (May 2018)
Code
PHP170
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Health Care Research
Disease
Multiple Diseases, Rare and Orphan Diseases