Safety Information

Early Warning System - Monitoring Communication

M² Logo Possible risk of lichen planus or lichenoid drug eruption with zoster (shingles) vaccine or influenza vaccine

26 October 2018

Products Affected
Additional information
Regulator actions
Reporting
References

Monitoring finishes 31 July 2019.

Medsafe is highlighting a possible risk of lichen planus or lichenoid drug eruption with the use of zoster (shingles) vaccine or influenza vaccine. The aim is to encourage further reports and increase the information on this potential safety signal.

This potential safety signal was triggered by a report received by the Centre for Adverse Reactions Monitoring (CARM). The report (CARM ID number 125605) describes a 67-year-old female patient who experienced a lichen planus rash after receiving both zoster vaccine and influenza vaccine. The lichen planus rash was confirmed on punch biopsy. The patient was also taking other medicines including quinapril + hydrochlorothiazide which has been associated with lichenoid eruptions. 

Products Affected

Product name Sponsor
Influenza vaccine (quadrivalent)
Afluria Quad Seqirus (NZ) Ltd
Fluarix Tetra GlaxoSmithKline (NZ) Ltd
FluQuadri sanofi-aventis new zealand limited
Influvac Tetra Mylan New Zealand Ltd
Zoster (shingles) vaccine
Zostavax Merck Sharp & Dohme (New Zealand) Limited

Annual influenza vaccination is an important measure for preventing influenza infection and mortality1. The World Health Organization recommends which influenza strains should be contained in the vaccine each year. The effectiveness of influenza vaccine depends on the match of the strains in the vaccine with circulating strains, the age of the individual and whether they have any underlying conditions 1.

Zostavax is a live attenuated virus vaccine used to prevent herpes zoster (shingles). It reduces the burden of shingles by 61% in adults aged less than 60 years, 66% in those aged 60–69 years and by 55% in those aged 70 years and over 1.   

Influenza vaccine and zoster (shingles) vaccine are both funded on the National Immunisation Schedule for some patients. Patients can receive both vaccines at the same time using separate syringes and sites 1.

Additional information

Lichen planus is an uncommon, chronic T-cell mediated autoimmune skin condition in which inflammatory cells (white blood cells) attack an unknown protein within the skin and mucosal keratinocytes (a type of skin cell) 2 . The skin and oral mucosa (mouth) are the most frequently involved areas 2 .

There are many contributing factors to lichen planus, including genetic predisposition, stress, skin injury and viral infection 2. A localised skin disease such as shingles may also contribute to lichen planus and has been described in the literature 2, 3. This is known as an isotopic response – where a new skin reaction develops at the same site as a previous unrelated and already healed skin reaction 3 .

Lichen planus and lichenoid drug eruption have also been reported after vaccination. A recent study found hepatitis B vaccine, influenza vaccine and zoster vaccine to be the top three vaccines reported in association with lichen planus or lichenoid drug eruption 4 . The median time to onset reported in this study was 14 days.

The overall benefit-risk balance of zoster (shingles) vaccine and influenza vaccine remains positive.

Further advice on these vaccines and the known side effects is available in the consumer medicine information (CMI) leaflets and data sheets. The Immunisation Handbook provides clinical guidance for health professionals on the safest and most effective use of vaccines.

Search for consumer medicine information and data sheets

View or download the Immunisation Handbook

Search for information on lichen planus, shingles and other skin conditions on DermNet NZ

Regulator Actions

Medsafe is placing this safety concern on the medicines monitoring (M2 logo ) scheme to encourage reporting and obtain further information on this possible adverse reaction.

Reporting

Consumers and health professionals can send reports of suspected adverse reactions to CARM. Please report any cases of lichen planus or lichenoid drug eruption in patients who have received zoster vaccine or influenza vaccine. Please include information on the time to onset and location of the rash.

Medsafe cannot give advice about an individual’s medical condition. If you have any concerns about a medicine you are taking, Medsafe encourages you to talk to your healthcare professional.

References

  1. Ministry of Health. 2018. Immunisation Handbook 2017 (2nd edn). Wellington: Ministry of Health. URL: www.health.govt.nz/publication/immunisation-handbook-2017 (accessed 10 August 2018).
  2. DermNet NZ. 2015. Lichen planus October 2015. www.dermnetnz.org/topics/lichen-planus/ (accessed 10 August 2018).
  3. Lora V, Cota C and Kanitakis J. 2014. Zosteriform lichen planus after herpes zoster: report of a new case of Wolf's isotopic phenomenon and literature review. Dermatol Online J 20(11)
  4. Lai YC and Yew YW. 2017. Lichen planus and lichenoid drug eruption after vaccination. Cutis 100(6): E6-E20.