1m side effects reported under Yellow Card scheme

The Medicines and Healthcare products Regulatory Agency (MHRA) received its one millionth Yellow Card side effect report.

The Department of Health and Social Care (DHSC) said the milestone coincides with the launch of the 5th annual #MedSafetyWeek (November 2-8), which highlights the value of the Yellow Card scheme to the nation’s health, and the importance of reporting suspected side effects from medicines.

Reporting under the scheme helps to identify new drug side effects, as well as unexpected and serious safety problems.

It also adds to existing information about known effects. By reporting, patients and the public can help the safe use of medicines for everyone. It helps the MHRA to take action, through effective regulation.

DHSC said one recent positive change to medicines information for users involves a woman in the UK who has helped identify a newly recognised side effect from a blood pressure medication.

While pregnant, Liz noticed some unusual side effects when taking her medicine and reported it to the MHRA using the Yellow Card scheme.

‘Shortly after taking each dosage, I would feel an extreme burning sensation in my nipples which intensified over a period of about 20 minutes. It was agonising.

‘At first, I didn’t make the link between the tablets and the pain – I presumed it was just a pregnancy side effect. My doctor and other healthcare professionals weren’t aware of it as a reported side effect for my medication.

‘I decided to report my symptoms to Yellow Card because, however rare, I wanted to make sure anyone else experiencing it wouldn’t feel alone.

‘MHRA investigated my report alongside other reporting and clinical data and found that nipple pain was a symptom of Raynaud’s phenomenon, a known side effect of this particular medicine.

‘They worked with the manufacturers to improve the patient safety information – and the medicine now includes nipple pain as a possible side effect of Raynaud’s phenomenon.

‘It didn’t take much time to do and I’m glad that anyone else experiencing this problem will now understand its probable cause. It’s good to know I’ve been able to make a difference.’

MedSafetyWeek is a global campaign, with over 70 countries participating, worldwide. This year, the theme is ‘every report counts’.

The MHRA will be calling upon patients and carers, as well as healthcare professionals and their organisations to report suspected side effects from medicines.

Mick Foy, Head of Pharmacovigilance Strategy of MHRA’s Vigilance and Risk Management of Medicines Division, said: ‘Patient safety is our number one priority.

‘We want this campaign to encourage everyone to report suspected side effects from medicines and make more people aware of our Yellow Card scheme. This important milestone shows that every report counts and contributes to improving the safety of medicines for all patients.’

Photo Credit – Pixabay


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