NPC Archive Item: Swine flu: reporting suspected adverse reactions to oseltamivir▼, zanamivir▼ and future vaccines

NOTE – This is an archive post from the NPC and has not been updated since first publication. Therefore, some hyperlinks may no longer be working.

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7th July 2009

The MHRA has set up the Swine Flu ADR Portal to monitor the safety of oseltamivir (Tamiflu) and zanamivir (Relenza) as their use increases during the swine flu pandemic.

The MHRA is strongly encouraging healthcare professionals to use this web-based system to report suspected adverse drug reactions (ADRs) to oseltamivir▼ (Tamiflu), zanamivir▼ (Relenza) and H1N1 swine flu vaccines when they become available in the autumn.

What is the background to this?
A letter has been sent to healthcare professionals to inform them about this new online system for reporting suspected ADRs to the antiviral medicines and future swine flu H1N1 vaccines. It advises what information should be included when an ADR report is submitted:

  • The patient’s age
  • The indication (prophylaxis or treatment)
  • Information on any underlying risk factors for influenza complications or the ADR; or state if there are no known risk factors
  • Any other information about the patient or additional clinical details which may help to assess the case

As with the Yellow Card Scheme, the swine flu ADR portal will also be open to members of the public.

A section has been created on the MHRA website to collate all the information they publish relating to swine flu and a pandemic situation. Currently it provides an overview of the MHRA’s preparations and contingency plans, links to other websites relating to swine flu, and details on how to report suspected side effects to flu medicines. The MHRA plan to publish a summary of changes to legislation and accompanying guidance, warnings of the threat of counterfeit flu medicines, the dangers of obtaining treatments online, and contact details within the MHRA.

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