Europe

The Merck files, part 2: Merck responds to regulatory concerns about persistent adverse effects of Propecia

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In 2006, the Swedish Medical Products Agency asked Merck for an analysis of all adverse events affecting the male reproductive system which persisted after stopping Propecia. In subsequent documents, there is a back-and-forth between Merck and the Agency as to the validity of these reports and the overall safety concern. Merck used an arsenal of arguments to discount these reports and claim its own data is superior to postmarketing data.

Merck communications regarding reports of persistent erectile dysfunction and depression associated with finasteride

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See also: The Merck files: a series In regulatory, internal and media communications in the 2000s, Merck responded to concerns about reports of adverse events associated with Propecia, including persistent erectile dysfunction and depression. These documents seek to discount the validity of these reports by way of the following points: “insufficient” information including lack of … Read more