Editorial

Spontaneous Reports as Evidence of Adverse Drug Reactions

Authors: Sonal Singh, MD, Apurva N. Trivedi, MD

Abstract

In this issue of the Southern Medical Journal, Borras-Blasco et al1 describe a case of possible severe stomatitis complicating treatment with peginterferon α-2a (PEG-IFN) and ribavirin in a patient infected with the hepatitis C virus. This adverse drug reaction (ADR) occurred four weeks after initiation of therapy. Discontinuing both the drugs resulted in the resolution of stomatitis, without an opportunity for rechallenge. They cite two previous published reports of oral ulcerations with interferon therapy. Using the validated Naranjo probability scale, they rate this reaction to be possibly related to PEG-IFN α-2a (+1 point for previous reports, +2 points for temporality, +1 point for improvement after discontinuation) (>9 = definite ADR, 5–8 = probable ADR, 1–4 = possible ADR, 0 = doubtful ADR).2 In the absence of confounding factors, the temporality suggests a partial casual relationship.1

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References

1. Borras-Blasco J, Primo J, Rosique-Robles JD, et al. Severe stomatitis complicating treatment with peglated-interferon α-2a and ribavirin in an HCV-infected patient. South Med J 2008;101:88–90.
 
2. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239–245.
 
3. Hoffman-Roche. PegInterferon alfa-2a. Copyright at 2003–2007 Hoffman Roche Inc. Nutley, New Jersey, 2007.
 
4. MacKay IF, Garrah JM, Tabah BM, et al. Adverse drug reactions associated with the use of ribavarin in the treatment of severe acute respiratory syndrome (SARS). Can J Clin Pharmacol 2005;12:e165–e179.
5. Horn JR, Hansten PD, Chan LN. Proposal for a new tool to evaluate drug interaction cases. Ann Pharmacother 2007;41:674–680.
 
6. Loke YK, Price D, Derry S, et al. Case reports of suspected adverse drug reactions: systematic literature survey of follow-up. BMJ 2006;332:335–339.