Press release: Online reporting system for swine flu antiviral side effects

Press release

Date:	06 Jul 2009
Time:	12:30
Subject:	Swine Flu ADR Portal
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

Suspected side effects to swine flu antiviral medicines can now be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) via a new dedicated webpage (www.mhra.gov.uk/swineflu).

The online system is based on the highly successful Yellow Card Scheme and is designed to make completing a report quick and easy for the public as well as healthcare professionals. This will assist the MHRA in efficiently monitoring the safety of the swine flu antiviral medicines, Tamiflu and Relenza, as their use increases during the swine flu pandemic.

MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine, said Tamiflu and Relenza are acceptably safe and most people will not suffer any side effects.

“Like all medicines, the MHRA keeps the safety of these continually under review and we are keen to let people know there is a new way to tell us of any side effect suspicions.

“If someone thinks they may have had a side effect to their medication, they should see their healthcare professional first to check they are okay. They should then report it to the MHRA via the ‘Swine Flu ADR Portal’.

“If they are unable to access the Internet, their healthcare provider can send a report on their behalf.

“By providing this information, not only are the MHRA able to gain better insights into the safety of medicines, but people can directly contribute to effective medicines regulation.”

 

Notes to Editor

1. The UK has stockpiled the antiviral medicines Tamiflu and Relenza for management of the swine flu pandemic.
2. The existing Yellow Card Scheme will remain in operation during this time for reporting suspected ADRs to all other medicines.
3. The MHRA has received 20 suspected ADR reports to Tamiflu and no suspected ADR reports to Relenza since the start of the swine flu outbreak. No new risks have been identified.
4. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk