Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission Impossible
Whether aggressive prolonged dual antiplatelet therapy (DAPT) promotes solid cancer risks remains a critical unsolved issue. Since the evidence from randomized trials, affiliated U.S. Food and Drug Administration (FDA) reviews, meta-analyses, and national registries is mixed, the search is ongoing....
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Georg Thieme Verlag KG
2018-01-01
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| Series: | TH Open |
| Subjects: | |
| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0037-1615253 |
| _version_ | 1818142827507351552 |
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| author | Victor Serebruany Moo Hyun Kim Christian Thevathasan Thomas Marciniak |
| author_facet | Victor Serebruany Moo Hyun Kim Christian Thevathasan Thomas Marciniak |
| author_sort | Victor Serebruany |
| collection | DOAJ |
| description | Whether aggressive prolonged dual antiplatelet therapy (DAPT) promotes solid cancer risks remains a critical unsolved issue. Since the evidence from randomized trials, affiliated U.S. Food and Drug Administration (FDA) reviews, meta-analyses, and national registries is mixed, the search is ongoing. The FDA Adverse Event Reporting System (FAERS) is a global passive surveillance repository requiring mandatory updates for serious events. We assessed the frequencies of co-reporting any cancers with oral antiplatelet agent (OAA) strategies in FAERS. We examined the entire FAERS database (n = 8,604,889) with regard to monotherapy or DAPT with OAA, suspected causative role, and co-reporting any cancers (n = 433,111). We extracted cancer cases during monotherapy with aspirin (20,984 out of 462,371 or 4.54%), clopidogrel (2,797 out of 62,791 or 4.45%), prasugrel (119 out of 4,364 or 2.73%), and ticagrelor (144 out of 8.268 or 1.71%). DAPT with clopidogrel reported (2,453 out of 58,101, or 4.22%); prasugrel (162 out of 4,036, or 4.01%); and ticagrelor (195 out of 5,302 or 3.68%) cancer reports all on top of aspirin. We conclude that FAERS is currently unreliable for adequate assessment of cancer risks during DAPT. The retrieved evidence appears random and sporadic, while associated cancers are heavily underreported or/and missed. Without stricter rules, better surveillance, and enforcements, oncology outcome research options in FAERS are challenging. |
| first_indexed | 2024-12-11T11:21:58Z |
| format | Article |
| id | doaj.art-3216e5c279d443999e95c58520556fc2 |
| institution | Directory Open Access Journal |
| issn | 2512-9465 2512-9465 |
| language | English |
| last_indexed | 2024-12-11T11:21:58Z |
| publishDate | 2018-01-01 |
| publisher | Georg Thieme Verlag KG |
| record_format | Article |
| series | TH Open |
| spelling | doaj.art-3216e5c279d443999e95c58520556fc22022-12-22T01:09:09ZengGeorg Thieme Verlag KGTH Open2512-94652512-94652018-01-010201e28e3210.1055/s-0037-1615253Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission ImpossibleVictor Serebruany0Moo Hyun Kim1Christian Thevathasan2Thomas Marciniak3Division of Neurology, Johns Hopkins University, Baltimore, Maryland, United StatesDivision of Cardiology, Dong-A University, Busan, South KoreaUniversity College London, London, United KingdomBethany Beach, Delaware, United StatesWhether aggressive prolonged dual antiplatelet therapy (DAPT) promotes solid cancer risks remains a critical unsolved issue. Since the evidence from randomized trials, affiliated U.S. Food and Drug Administration (FDA) reviews, meta-analyses, and national registries is mixed, the search is ongoing. The FDA Adverse Event Reporting System (FAERS) is a global passive surveillance repository requiring mandatory updates for serious events. We assessed the frequencies of co-reporting any cancers with oral antiplatelet agent (OAA) strategies in FAERS. We examined the entire FAERS database (n = 8,604,889) with regard to monotherapy or DAPT with OAA, suspected causative role, and co-reporting any cancers (n = 433,111). We extracted cancer cases during monotherapy with aspirin (20,984 out of 462,371 or 4.54%), clopidogrel (2,797 out of 62,791 or 4.45%), prasugrel (119 out of 4,364 or 2.73%), and ticagrelor (144 out of 8.268 or 1.71%). DAPT with clopidogrel reported (2,453 out of 58,101, or 4.22%); prasugrel (162 out of 4,036, or 4.01%); and ticagrelor (195 out of 5,302 or 3.68%) cancer reports all on top of aspirin. We conclude that FAERS is currently unreliable for adequate assessment of cancer risks during DAPT. The retrieved evidence appears random and sporadic, while associated cancers are heavily underreported or/and missed. Without stricter rules, better surveillance, and enforcements, oncology outcome research options in FAERS are challenging.http://www.thieme-connect.de/DOI/DOI?10.1055/s-0037-1615253antiplatelet agentscancersafetyregistryfaers |
| spellingShingle | Victor Serebruany Moo Hyun Kim Christian Thevathasan Thomas Marciniak Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission Impossible TH Open antiplatelet agents cancer safety registry faers |
| title | Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission Impossible |
| title_full | Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission Impossible |
| title_fullStr | Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission Impossible |
| title_full_unstemmed | Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission Impossible |
| title_short | Assessing Cancer Signal during Oral Antiplatelet Therapy in the Food and Drug Administration Adverse Event Reporting System: Mission Impossible |
| title_sort | assessing cancer signal during oral antiplatelet therapy in the food and drug administration adverse event reporting system mission impossible |
| topic | antiplatelet agents cancer safety registry faers |
| url | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0037-1615253 |
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