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. 2013 Aug;3(4):288-294.
doi: 10.1212/CPJ.0b013e3182a1b9f0.

Postmarketing adverse drug reactions: A duty to report?

Eran Klein  1 , Dennis Bourdette
Affiliations

Postmarketing adverse drug reactions: A duty to report?

Eran Klein et al. Neurol Clin Pract. 2013 Aug.

Abstract

Physicians play an important role in recognizing and reporting suspected adverse drug reactions (ADRs) to the Food and Drug Administration (FDA). Physicians can report suspected ADRs directly to the FDA via its MedWatch program, by contacting the manufacturer of the drug, and by publishing case reports. While this takes time, physicians have an ethical obligation to participate in recognizing and reporting ADR.

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References

    1. Espinosa PS, Berger JR. Delayed fingolimod-associated asystole. Mult Scler 2011;17:1387–1389 - PubMed
    1. FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod). Available at: http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm. Accessed February 13, 2013
    1. Aagaard L, Hansen EH. Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs. BMC Clin Pharmacol 2009;9:4. - PMC - PubMed
    1. Light DW. The Risks of Prescription Drugs. New York: Columbia University Press; 2010
    1. Institute of Medicine Preventing Medication Errors: Quality Chasm Series. Washington, DC: National Academy Press; 2006