scholarly journals Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration

2015 ◽  
Vol 175 (9) ◽  
pp. 1565 ◽  
Author(s):  
Paul Ma ◽  
Iván Marinovic ◽  
Pinar Karaca-Mandic
2018 ◽  
Vol 5 (4) ◽  
pp. 210-215 ◽  
Author(s):  
Victor L Serebruany ◽  
Trygve S Hall ◽  
Dan Atar ◽  
Stefan Agewall ◽  
Moo Hyun Kim ◽  
...  

Abstract Aims Clopidogrel is commonly used even after expiring patents. The brand clopidogrel (BC) was dealt by single company, while numerous manufacturers produce generic clopidogrel (GC). There are no convincing data to compare the safety of different formulations. Therefore, the data yielded from international, uniform, government-mandated registries may be useful. Methods and results We assessed primary causative adverse events (PCAE) after BC and GC in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). The outcomes were divided into death, cardiac, thrombotic/embolic, haemorrhagic, and rash/dermal complications. These primary endpoints were then examined by proportional reporting ratios (PRR) and chi-square (χ2). Among total FAERS (n = 9 466 679) reports, overall BC (n = 88 863) cases were more common than after GC (n = 36 559). When triaged by PCAE role, BC (n = 18 328) was also more abundant than GC (n = 3987). The reported death rates were more than doubled after BC [18.4% vs. 7.0%; PRR = 0.38; 95% confidence interval (95% CI) 0.32–0.43; χ2=369.7; P<0.0001] for total FAERS, and consistent for late 2010–2017 (17.6% vs. 7.0% PRR = 0.40; 95% CI 0.37–0.45; χ2=286.2; P<0.004) PCAE cases. In contrast, GC trended to co-report more cardiac (14.6% vs. 13.3%; PRR = 1.12; 95% CI 1.0–1.25; χ2=3.5; P<0.06). The haemorrhagic (40.9% vs. 32.3%; PRR = 1.45; 95% CI 1.33–1.57; χ2=75.8; P<0.0001), and rash/dermal (5.4% vs. 4.6%; PRR = 1.20; 95% CI 1.0–1.44; χ2=3.75; P<0.05) events were also more common for GC. Thrombotic/embolic events were reported equally (at 7.0%) after each formulation. Conclusion The PCAE profiles differ with BC and GC in FAERS. While deaths reports were higher, the rates of cardiac, haemorrhagic, and skin complications were less common for BC. Despite expected reporting bias, this may indicate that the manufacturers of GC are reluctant to report deaths to the FDA. However, the overall adverse event profile suggests potentially better safety of BC over GC formulations.


Dermatitis ◽  
2016 ◽  
Vol 27 (4) ◽  
pp. 236-237 ◽  
Author(s):  
Linda M. Katz ◽  
Claudia Valenzuela ◽  
Nakissa K. Sadrieh

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1387
Author(s):  
Shahad Saif Khandker ◽  
Brian Godman ◽  
Md. Irfan Jawad ◽  
Bushra Ayat Meghla ◽  
Taslima Akter Tisha ◽  
...  

COVID-19 vaccines are indispensable, with the number of cases and mortality still rising, and currently no medicines are routinely available for reducing morbidity and mortality, apart from dexamethasone, although others are being trialed and launched. To date, only a limited number of vaccines have been given emergency use authorization by the US Food and Drug Administration and the European Medicines Agency. There is a need to systematically review the existing vaccine candidates and investigate their safety, efficacy, immunogenicity, unwanted events, and limitations. The review was undertaken by searching online databases, i.e., Google Scholar, PubMed, and ScienceDirect, with finally 59 studies selected. Our findings showed several types of vaccine candidates with different strategies against SARS-CoV-2, including inactivated, mRNA-based, recombinant, and nanoparticle-based vaccines, are being developed and launched. We have compared these vaccines in terms of their efficacy, side effects, and seroconversion based on data reported in the literature. We found mRNA vaccines appeared to have better efficacy, and inactivated ones had fewer side effects and similar seroconversion in all types of vaccines. Overall, global variant surveillance and systematic tweaking of vaccines, coupled with the evaluation and administering vaccines with the same or different technology in successive doses along with homologous and heterologous prime-booster strategy, have become essential to impede the pandemic. Their effectiveness appreciably outweighs any concerns with any adverse events.


2020 ◽  
Vol 180 (1) ◽  
pp. 147 ◽  
Author(s):  
Lily Meier ◽  
Elizabeth Y. Wang ◽  
Madris Tomes ◽  
Rita F. Redberg

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