Excess Ticagrelor Mortality in the Food and Drug Administration Adverse Event Reporting System: Time to Recount PLATO Trial Deaths

Am J Med. 2017 Jun;130(6):e245-e246. doi: 10.1016/j.amjmed.2016.12.037. Epub 2017 Feb 1.

Authors

Victor L Serebruany¹, Seth D Fortmann², Vasily Cherepanov², Oleg Litvinov², Moo Hyun Kim³, Thomas A Marciniak⁴

Affiliations

¹ Department of Neurology, Johns Hopkins University, Baltimore, Md; HeartDrug Research Laboratories, Towson, Md.
² HeartDrug Research Laboratories, Towson, Md.
³ Department of Cardiology, Dong-A University, Busan, South Korea.
⁴ Retired from the US Food and Drug Administration, Bethesda, Md.

PMID: 28161342
DOI: 10.1016/j.amjmed.2016.12.037

No abstract available

Publication types

Editorial

MeSH terms

Adenosine / adverse effects
Adenosine / analogs & derivatives*
Adenosine / therapeutic use
Adverse Drug Reaction Reporting Systems*
Cardiovascular Diseases / drug therapy
Cardiovascular Diseases / mortality*
Clinical Trials as Topic
Drug-Related Side Effects and Adverse Reactions / mortality*
Humans
Purinergic P2Y Receptor Antagonists / adverse effects*
Purinergic P2Y Receptor Antagonists / therapeutic use
Ticagrelor
United States / epidemiology
United States Food and Drug Administration

Substances

Purinergic P2Y Receptor Antagonists
Ticagrelor
Adenosine