Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what reports he has received on the number of people who have been adversely affected by Gadolinium.

Reports of ‘suspected’ Adverse Drug Reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme, the Yellow Card Scheme. The Scheme collects suspected ADR reports from the whole of the United Kingdom in relation to all medicines and vaccines. Reporting to the Yellow Card Scheme is voluntary for healthcare professionals and members of the public, there is however also a legal obligation for pharmaceutical companies to report all serious ADRs for their products that they are aware of.

A summary of the reports received by the MHRA of people who have had a suspected adverse reaction to a gadolinium containing agent is published as an interactive Drug Analysis Profiles (iDAP) on the Yellow Card websiteiDAPs are listed by substance and there are several Gadolinium-containing contrast agents (GdCAs). The GdCAs to note are gadodiamide (Omniscan), gadoversetamide (Optimark), gadopentetic acid (Magnevist), gadobenic acid (Multihance), gadoxetic acid (Primovist), gadoteridol (Prohance), gadobutrol (Gadovist) and gadoteric acid (Dotarem).

The first UK spontaneous ADR report received by the MHRA in association with a GdCA was reported in 15 July 1991 and the table below provides the number of reports and reactions reported for each contrast agent as of 31 October 2017. It should be noted that one report can contain multiple reactions.

Yellow Card data cannot be used as a reliable indicator of the frequency of suspected ADRs to medicines. The level of ADR reporting may fluctuate between given years due to a variety of reasons such as a medicine being new (reporting rates are generally higher when a product is first introduced), stimulated interest/publicity and variations in exposure to the medicine. The data should be seen in the context of the many millions of people who have received gadolinium containing contrast agents.

It is also important to note that Yellow Card reports are not proof of a side effect occurring but only a suspicion by the reporter that the medicine may have caused the symptoms. Yellow Card reports may therefore relate to true side effects of the medicine, or they may be due to coincidental illnesses that would have occurred in the absence of medicine.