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Ashfield Pharmacovigilance was providing routine pharmacovigilance for a client’s low risk product. This product had no black box, no Risk Evaluation and Mitigation Strategy (REMS) and was not a direct to consumer product. At the time, signal detection was not required by the EU or strongly recommended by the FDA. Therefore, no formal signal detection program was being implemented for this product.


During the triage stage of case processing, one of the client’s dedicated case managers noted an Adverse Event coded as a severe cutaneous adverse reaction. The case manager had seen three cases for this drug with similar events and quickly made the connection that this could be a potential signal. The Case Manager escalated this information to Ashfield Pharmacovigilance’s physician, who in turn brought it to the attention of Ashfield Pharmacovigilance’s Safety Evaluation Committee.


During the Safety Evaluation Committee meeting it was agreed that the Adverse Events warranted identifying cases of interest, developing a case series and performing literature review. This course of action was communicated to the client and project team, who arrived at an agreement. The Safety Evaluation Committee identified many compelling cases, applied the Naranjo causality scale, generated summaries and tables, and communicated recommendations to client.

Following the Safety Evaluation Committee’s recommendations, Ashfield Pharmacovigilance assisted with the development of a targeted follow-up questionnaire. Additionally, Ashfield Pharmacovigilance assisted the client with the development of a label review committee to initiate a possible label update. As a result, these adverse event’s were deemed to be a true signal and resulted in a label change.

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