Angus Files
MHRA
xxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxxxxx.xxx
151 Buckingham Palace Road
London
SW1W 9SZ
United Kingdom
www.gov.uk/mhra
14th November 2017
Dear Mr Files,
FOI 17/460
Thank you for your email dated 17 October 2017, where you requested:
1. The names of the 12 products and 10 vaccines that have been removed from the UK market
due to safety concerns
2. The total number of Yellow Card submissions for each year since the start of the MHRA
Please allow me to clarify our initial response to FOI 17/419. Since the MHRA came into being in 2003
to present, 12 medicinal products have been removed from the UK market due to the identification of
safety risks. No vaccines have been removed from the UK market to date as a result of safety risks.
We apologise for any misinterpretation. Please find below the details of the medicinal products
removed from the UK market.
Table 1: Medicinal Products removed from the UK Market due to safety concerns since the inception
of the MHRA in 2003
Drug substance (Brand name)
Date first
Year action Major safety concerns
authorised
taken
Rofecoxib (Vioxx)
04/06/1999
2004
Myocardial infarction/stroke
Valdecoxib (Bextra)
27/03/2003
2005
Serious skin reactions
Co-proxamol
31/07/1977
2006
Toxicity in overdose
Lumiracoxib (Prexige)
12/09/2003
2007
Liver toxicity
Carisoprodol (Carisoma)
02/04/1982
2008
Risk of abuse, addiction and
psychomotor impairment
Rimonabant (Acomplia)
19/06/2006
2008
Psychiatric reactions
Efalizumab (Raptiva)
20/09/2004
2009
Progressive Multifocal
Leukoencephalopathy (PML)
Orciprenaline sulphate (Alupent)
27/06/1978
2009
Increased risk of cardiovascular
side effects
Sibutramine (Reductil)
11/05/2001
2010
Increased risk of cardiovascular
side effects
Rosiglitazone (Avandia)
11/07/2000
2010
Increased risk of cardiovascular
side effects
Sitaxentan (Thelin)
10/08/2006
2011
Liver toxicity
Niacin-laropiprant (Tredaptive)
03/07/2008
2013
Increased incidence of non-fatal
serious adverse events and lack
of efficacy
Bextra, Raptiva, Avandia, Thelin and Tredaptive were licensed through the centralised procedure
with the European Medicines Agency as the Licensing Authority. The primary data source which
identified safety concerns with these medications may not have been Yellow Card data however
Yellow Card reports may have been assessed as part of the overall safety evaluation.
With regards to your request for the number of Yellow Cards the MHRA receives please find below
the total numbers of Yellow Card reports received by the MHRA per year.
Table 3: Total number of Yellow Card reports received per year since the inception of the MHRA in
2003
Year
Total Number of Yellow Cards
received
2003
19187
2004
19926
2005
21828
2006
21418
2007
21179
2008
25003
2009
25438
2010
23293
2011
25100
2012
25886
2013
30917
2014
31442
2015
38957
2016
42149
2017*
35115
*Year to 22nd October 2017
As previously advised when evaluating safety concerns, Yellow Card data is considered in conjunction
with all of the other available cumulative evidence rather than in isolation. This includes clinical trial
data, published medical literature and data from other worldwide regulatory agencies. It is important
to note that spontaneous data has a number of limitations and in order for robust regulatory decision
making all evidence must be considered. It is important to note that a report of a suspected adverse
reaction via the Yellow Card Scheme does not necessarily mean that it was caused by the drug. Many
factors have to be taken into account in assessing causal relationships including temporal association,
the possible contribution of concomitant medication and any underlying illness. Because of this, and
due to a variable level of under-reporting, Yellow Card reports also cannot be used to estimate the
frequency of possible side effects.
The MHRA is continually looking for ways to promote the Scheme and facilitate reporting and, as a
result, the numbers of Yellow Card reports received has increased in recent years. As part of the
Yellow Card strategy the MHRA regularly engages with Royal Colleges, healthcare professional
bodies, patient support organisations and charities to disseminate key messages around reporting.
Other initiatives undertaken include development of education modules for healthcare professionals
and implementation of electronic Yellow Card reporting directly from patient healthcare records. Most
recently, the MHRA led on the development of promotional materials for a social media campaign
specifically on raising awareness levels of national Adverse Drug Reaction (ADR) reporting systems
that was run in November 2016 across the EU and due to be repeated this November.
I hope the information provided is helpful, but if you are dissatisfied with the handling of your request,
you have the right to ask for an internal review. Internal review requests should be submitted within
two months of the date of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division
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the Communications Directorate, 4-T, Medicines and Healthcare products Regulatory Agency, (via
this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner
at:
The Information Commissioner’s Office
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