Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2008 Mar 22;336(7645):627-8.
doi: 10.1136/bmj.39491.493252.80.

Observational evidence for determining drug safety

Nick Freemantle, Alar Irs
Editorial

Observational evidence for determining drug safety

Nick Freemantle et al. BMJ. .

Abstract

Is no substitute for evidence from randomised controlled trials

PubMed Disclaimer

Conflict of interest statement

NF has received funding from drug companies (but not the manufacturer of aprotinin) for research, consultation, and educational services in the area of drug efficacy and safety. AI is employed by the Estonian State Agency of Medicines (SAM) and is a member of the European Medicines Agency’s (EMEA) committee for medicinal products for human use (CHMP) and paediatric committee (PDCO). The views expressed in the article are his own and not those of SAM or EMEA.

Comment in

References

    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. - PubMed
    1. 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/doc...
    1. Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006;354:353-65. - PubMed
    1. 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. - PubMed
    1. 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

Publication types

MeSH terms