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Regulator seeks more data on side effects of drugs

MHRA campaigns to gather data on side effects

Adrian O'Dowd

Monday, 20 November 2017

The Medicines Healthcare products Regulatory Agency (MHRA) is today launching a social media campaign to highlight and promote reporting of suspected side effects from over-the-counter medicines.

The campaign running from 20th to 24th November 2017 is designed to help make medicines safer by encouraging more reporting of suspected side effects from over-the-counter medicines, as part of an EU-wide awareness week.

The MHRA said that although medicines were safe and effective, side effects could happen, even with over-the-counter medicines, therefore it was important that the risks associated with all medicines were understood and communicated to health professionals and patients.

Potential side effects included headache, sore stomach, and flu-like symptoms and if patients reported these regularly, this could help regulators monitor medicines on the market and take appropriate action.

National reporting systems for collecting suspected adverse drug reactions act as early warning systems, it said, to help identify numerous important safety issues, many of which were not recognised as being related to a particular medicine until reports were received by medicines regulators.

Despite its best efforts, the MHRA said its reporting system suffered from under-reporting so the campaign could raise awareness and strengthen the system.

Mick Foy, group manager for MHRA’s vigilance and risk management of medicines division, said: “The most important part of our work is making sure the medicines you and your family take are effective and acceptably safe.

“Our campaign will help the public, patients and healthcare professionals report potential side effects and have confidence that their reports are making a difference. You can help make medicines safer by reporting any suspected side effects easily and quickly online through the Yellow Card Scheme.”

The campaign is part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action project, which aims to raise awareness of national reporting systems for suspected side effects in medicines.

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