HPV vaccination
Varenicline and self-harm
Uncomfortable ulcers: Nicorandil-induced genital ulcers.

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Report here: http://www.yellowcard.gov.uk

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.

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

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.

Topics include:

• Does the colour of your tablet matter?
• Anaemia from ayurvedic lead
• Salivary glands and thiazolidindiones
• Side effect or adverse drug reaction?

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

Patients can report adverse drug reactions at http://www.yellowcard.gov.uk