Observational evidence for determining drug safety

BMJ

Volumn 336, Issue 7645, 2008, Pages 627-628

  Freemantle, Nick ^a   Irs, Alar ^b  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b UNIVERSITY OF TARTU   (Estonia)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOCAPROIC ACID; APROTININ; TRANEXAMIC ACID;

BLEEDING; BLOOD TRANSFUSION; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EDITORIAL; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEART SURGERY; HUMAN; PRIORITY JOURNAL; PROGNOSIS; RISK ASSESSMENT; RISK FACTOR; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; DRUG TOXICITY; RANDOMIZED CONTROLLED TRIAL; UNITED STATES;

DRUG TOXICITY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 41449106895     PISSN: 09598146     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmj.39491.493252.80     Document Type: Editorial

References (6)

1. Fruberg CD, Levin AA, Gross PA, Shapiro RS, Strom BL. The FDA and drug safety: a proposal for sweeping change. Arch Intern Med 2006;166:1938-42.
2. European Commission. Strategy to better protect public health by strengthening and rationalising EU pharmacovigilance: public consultation on legislative proposals. 2007. http://ec.europa.eu/enterprise/pharmaceuticals/ pharmacovigilance_acs/docs/public-consultation_12-2007.pdf.
3. Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006;354:353-65.
4. Mangano DT, Miao Y, Vuylsteke A, Tudor IC, Juneja R, Filipescu D, et al. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA 2007;297:471-9.
5. Food and Drug Administration. Early communication about an ongoing safety review aprotinin injection (marketed as trasylol). 2007. www.fda.gov/cder/drug/early_comm/aprotinin.htm.
6. Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McCelland B, et al. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2007;(4):CD001886.