admin November 30th, 2009
The Yellow Card Centre West Midlands has issued re:Action number 38:
HPV vaccination
Varenicline and self-harm
Uncomfortable ulcers: Nicorandil-induced genital ulcers.
[PDF]
admin November 7th, 2009
Report here: http://www.yellowcard.gov.uk
admin January 26th, 2009
The Yellow Card Centre West Midlands has published the 37th edition of their newsletter Reaction. PDF here. It includes:
Sex, drugs, & dental pain
Sexual dysfunction related to celecoxib.
Dropping into depression
Depression associated with topically applied beta-adrenergic receptor antagonists.
A prod about jabs
A discussion about the importance of reporting adverse reactions to vaccines.
admin September 12th, 2008
Readers are reminded that adverse reactions to vaccines can be reported to the Yellow Card Scheme via the Yellow Cards in the BNF, and online. The following is a letter related to the Human papillomavirus (HPV) immunisation programme from the MHRA.
2 September 2008
Dear Colleague
Human papillomavirus (HPV) immunisation programme – reporting adverse reactions via the Yellow Card Scheme
The routine immunisation programme for HPV vaccine, Cervarix, is commencing across the UK. I am writing to clarify arrangements for reporting suspected adverse reactions (ADRs) via the Yellow Card Scheme and to seek your help in optimising the value of reporting in relation to Cervarix.
Many adolescents will be immunised with the vaccine over a relatively short time in the coming months. Following the specific guidance outlined below will help us monitor the safety of Cervarix vaccine effectively. The most common side-effects have been established in clinical trials and these are listed in the product information (available via http://emc.medicines.org.uk). However, as with all vaccines and medicines used in the UK, it is important that the MHRA monitors the safety of Cervarix during routine use.
How to report a suspected ADR
- Please report via the Yellow Card Scheme ADRs that you suspect may have been caused by Cervarix.
We strongly encourage you to report online at www.yellowcard.gov.uk If you need a paper form, these are available in the BNF.- Please report only reactions that you suspect may be related to the vaccine and not those associated with the injection process or procedure – see below.
Faints and panic attacks
Fainting (or vasovagal syncope) and panic attacks, including mass episodes, can occur during, following, or even before, vaccination. The clinical features of such events are described in chapter 8 of the ‘Green Book’. It is important that procedures are in place to avoid injury from faints and to ensure that any sudden loss of consciousness is distinguished from a possible anaphylactic reaction (see below). Faints or panic attacks occurring during or very shortly after vaccination are usually a psychogenic response to the needle injection and not a true side-effect of the vaccine.If having considered this advice, you wish to report an episode which may have been psychogenic, please include only the main diagnosis or event as the suspected reaction (e.g. ‘faint’ or ‘panic attack’). Any associated symptoms (such as loss of consciousness, injury, limb jerking or tingling, difficulty in breathing, hyperventilation etc) should not be reported as a suspected adverse reaction. If necessary, they can be included as ‘additional information’ on the form.
Anaphylaxis and other allergic reactions
Anaphylaxis is a very rare side-effect of most vaccines. It is essential that we distinguish between reports of anaphylaxis and less serious allergic reactions or psychogenic events. The ‘Green Book’ gives further guidance on this. If you suspect a true case of anaphylaxis, please report it as such via the Yellow Card Scheme. We may need to contact you for confirmation. When reporting less severe allergic reactions please report only as ‘allergic reaction’ or other relevant description. Any signs or symptoms of anaphylaxis or other allergic reactions should be reported only as ‘additional information’ on the Yellow Card.If you require further information on the role of the MHRA and the Yellow Card Scheme, please visit www.mhra.gov.uk. Further information on the vaccine can be found at www.mhra.gov.uk/HPVvaccine.
Remember, every Yellow Card report matters. Thank you for your help in monitoring the safety of this important new vaccine.
Yours faithfully,
Professor Kent Woods, Chief Executive
admin January 8th, 2008
The West Midlands Centre for Adverse Drug Reactions wishes all of our readers a Happy New Year. We hope you have a prosperous 2008, and don’t forget to report any adverse drug reactions you come across.
admin November 20th, 2007
Lumiracoxib has been withdrawn from the UK market after a series of spontaneous reports of liver toxicity collected worldwide. Lumiracoxib was withdrawn in Canada last month, and in August of this year the MHRA imposed some restrictions on the use of lumiracoxib. Further cases have undermined the usefulness of that advice:
Recently, several new cases of serious hepatotoxicity have been identified following exposure to the licensed 100mg dose, and after short duration of treatment (less than one month in some cases). CHM concluded that recently introduced risk minimisation measures (baseline and monthly liver function test monitoring, and contraindications for patients with current or previous hepatic dysfunction) cannot be relied upon to guarantee patient safety, and further restrictions are unlikely to be practical. CHM considered that urgent action was required in order to protect public health, and that suspension of Marketing Authorisation for lumiracoxib was warranted.
A further press release and advice is available at the MHRA website.
Bottom line: Patients who are obtaining benefit from lumiracoxib may continue treatment until they have arranged an appointment with their doctor at the next convenient opportunity, at which alternative treatment can be discussed. Patients who are taking lumiracoxib and who feel unwell should stop taking lumiracoxib immediately seek medical attention. Any adverse effects to lumiracoxib should be reported at yellowcard.gov.uk.
admin October 31st, 2007
Yellow Card Centre West Midlands has published re:Action number 35. PDF available here.
Topics include:
admin December 11th, 2006
re:Action 34, our occasional bulletin, has been published. The PDF is here, and back issues are here. Topics include:
Pisa syndrome: an antipsychotic dystonia
Recent changes to the Yellow Card scheme
Sharing our expertise
If you make one report this year…
Aid on NSAIDs
Lamotrigine and birth defects
Combining antithrombotics: a bleed may follow
admin November 8th, 2006
We have produced a poster for local pharmacies and GP surgeries to promote the patient reporting of adverse drug reactions. You can download a printable PDF version here.
Patients can report adverse drug reactions at http://www.yellowcard.gov.uk
admin January 18th, 2005
The MHRA have announced that Yellow Card data will now be publically available on their website.
Patients and researchers will be able to look at data on the safety of different medicines announced Health Minister, Lord Warner today. The move is part of a series of measures to further improve the drug side effect reporting system – theYellow Card Scheme, which is used by the medicines watchdog (MHRA) to monitor the safety of medicines in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) will publish anonymous data on suspected adverse drug reactions on their website. Researchers will also be able to access more detailed data and measures will be put in place to prevent potential abuse of the information. Every request will be reviewed by an independent commitee to make sure it is ethically and scientifically sound and protects patient confidentiality.
As well as this patient reports will now be accepted:
The first pilots of patients directly reporting unexpected effects of drugs to the regulator were also launched. Forms to report unexpected drug reactions will available in 4000 GP surgeries across the UK and patients will also be able to make reports online.
Links:
Drug analysis printouts (DAPs) - these data are up to January 2004
Patient reporting form
Patient reporting launched.
Questions and Answers. [PDF]
Response to consultation on Yellow Card Scheme. [PDF]
Yellow Card Scheme review. [PDF]