12 April 2018: Monofer Solution for Injection & Infusion (Iron Isomaltoside)
Published 4 May 2018
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Email Communication to UK healthcare professionals
Pharmacosmos UK complained to MHRA about an e-mail communication relating to Monofer that had apparently been sent to individual healthcare professionals working in several NHS Foundation Trusts in early 2018 by an organisation named ‘PharmaAlerts.com’ from [email protected]. The e-mail communication contained attachments purportedly from a foreign pharmacovigilance authority, that were published in July 2017.
Pharmacosmos claimed that the foreign pharmacovigilance authority only published a statement about the product in the local language but that the sender of the e-mails had created an English version of the document and made it appear as if it had been issued recently by the foreign authority. Concerns were raised about the sender’s intent and the potential risk posed to patient safety, particularly from the unauthorised dissemination of product safety information from a foreign pharmacovigilance authority, and the inappropriate use of the authority’s letterhead.
MHRA wrote to PharmaAlerts.com at [email protected] but did not receive a response. We provided advice to Pharmacosmos that we would not view a factual response that set out the current regulatory position and was sent to known recipients of the emails as unsolicited promotion of Monofer.