» Articles » PMID: 25292435

Improving Postapproval Drug Safety Surveillance: Getting Better Information Sooner

Overview
Publisher Annual Reviews
Specialties Pharmacology
Toxicology
Date 2014 Oct 9
PMID 25292435
Citations 6
Authors
Affiliations
Soon will be listed here.
Abstract

Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include the establishment of government-sponsored networks of population databases, the use of data mining approaches, and the formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks and in providing reassurance about the absence of such risks.

Citing Articles

Predicting Drug Blood-Brain Barrier Penetration with Adverse Event Report Embeddings.

Wu Y, Mower J, Ding X, Li O, Subramanian D, Cohen T AMIA Annu Symp Proc. 2023; 2022:1163-1172.

PMID: 37128462 PMC: 10148361.


Data Mining for Adverse Events of Tumor Necrosis Factor-Alpha Inhibitors in Pediatric Patients: Tree-Based Scan Statistic Analyses of Danish Nationwide Health Data.

Wintzell V, Svanstrom H, Melbye M, Ludvigsson J, Pasternak B, Kulldorff M Clin Drug Investig. 2020; 40(12):1147-1154.

PMID: 33104987 PMC: 7701063. DOI: 10.1007/s40261-020-00977-5.


Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response.

Brewer S, Campagna E, Morrato E J Clin Transl Sci. 2019; 3(4):199-209.

PMID: 31660244 PMC: 6799639. DOI: 10.1017/cts.2019.400.


Building a framework for the evaluation of knowledge translation for the Canadian Network for Observational Drug Effect Studies.

Sketris I, Carter N, Traynor R, Watts D, Kelly K Pharmacoepidemiol Drug Saf. 2019; 29 Suppl 1:8-25.

PMID: 30788900 PMC: 6972643. DOI: 10.1002/pds.4738.


Drospirenone-containing oral contraceptives and venous thromboembolism: an analysis of the FAERS database.

Madigan D, Shin J Open Access J Contracept. 2018; 9:29-32.

PMID: 29720882 PMC: 5919164. DOI: 10.2147/OAJC.S161737.


References
1.
Ekstrom N, Schioler L, Svensson A, Eeg-Olofsson K, Jonasson J, Zethelius B . Effectiveness and safety of metformin in 51 675 patients with type 2 diabetes and different levels of renal function: a cohort study from the Swedish National Diabetes Register. BMJ Open. 2012; 2(4). PMC: 3400073. DOI: 10.1136/bmjopen-2012-001076. View

2.
Nissen S . ADHD drugs and cardiovascular risk. N Engl J Med. 2006; 354(14):1445-8. DOI: 10.1056/NEJMp068049. View

3.
Lindquist M, Edwards I . Risks of non-sedating antihistamines. Lancet. 1997; 349(9061):1322. DOI: 10.1016/S0140-6736(97)26018-6. View

4.
Pirmohamed M, James S, Meakin S, Green C, Scott A, Walley T . Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004; 329(7456):15-9. PMC: 443443. DOI: 10.1136/bmj.329.7456.15. View

5.
Kuhn M, Campillos M, Letunic I, Jensen L, Bork P . A side effect resource to capture phenotypic effects of drugs. Mol Syst Biol. 2010; 6:343. PMC: 2824526. DOI: 10.1038/msb.2009.98. View