Published: 31 May 2021
Updated:  19 February 2022

Safety Information

Monitoring

Patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your healthcare professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Pregabalin and the possible risk of bullous dermatitis and exfoliating skin reactions – Monitoring closes 25 November 2021

Update to original communication

During the monitoring period (25 May 2021 to 25 November 2021), one non-serious case of bullous rash after starting pregabalin was reported to the Centre for Adverse Reactions Monitoring (CARM).

The balance of benefits and risks of harm for pregabalin remains positive and no further action is required at this time.

Original communication

25 May 2021

Monitoring closes 25 November 2021.

Medsafe is highlighting a possible risk of bullous dermatitis or exfoliative skin reactions with pregabalin. The aim of this communication is to encourage further reports to obtain more information on this potential safety concern.

This potential safety concern was triggered by a report received by the Centre for Adverse Reactions Monitoring (CARM). The report (CARM ID 136065) describes an 87-year-old woman who developed a widespread blistering rash approximately four days after starting pregabalin.

Products affected
Additional information
Regulator actions
Reporting

Products affected

Product name	Sponsor
Pregabalin
Pregabalin Pfizer capsule	Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Pregabalin is indicated for the treatment of neuropathic pain in adults, and also as adjunctive therapy in adults with partial seizures with or without secondary generalisation¹.

Additional information

Bullous dermatitis is a general term that encompasses a number of blistering skin conditions. The mechanism depends on the type of reaction, but many are thought to be immune-mediated. Like bullous dermatitis, skin exfoliation can be a feature of severe cutaneous adverse reactions [2-4].

CARM has received four reports of skin reactions with pregabalin, two of which were bullous reactions and two of which were exfoliative skin reactions (CARM IDs: 96253, 131650, 136065, 139207).

Although this potential safety concern was triggered by a case of bullous dermatitis, we also encourage reporting of other skin reactions that may be related to severe cutaneous adverse reactions with pregabalin.

Advice on how to take this medicine and known side effects can be found in the consumer medicine information (CMI) and data sheet.

Search for consumer medicine information and data sheets

Regulator actions

Medsafe is placing this safety concern on the Medicines Monitoring ( ) scheme to encourage reporting of bullous dermatitis and exfoliative skin reactions with pregabalin.

Reporting

Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).

References

1. Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics. 2020. Pregabalin Pfizer New Zealand Data Sheet 18 November 2020. URL: www.medsafe.govt.nz/profs/Datasheet/l/Lyricacaps.pdf (accessed 23 April 2021).
2. Dyall-Smith D. 2009. Bullous drug eruptions 2009. URL: www.dermnetnz.org/topics/bullous-drug-eruptions/ (accessed: 22 April 2021).
3. Purvis D and Oakley A. 2015. Acute generalised exanthematous pustulosis September 2015. URL: dermnetnz.org/topics/acute-generalised-exanthematous-pustulosis/ (accessed 6 May 2021).
4. Rademaker M and Oakley A. 2016. Drug hypersensitivity syndrome September 2015. URL: dermnetnz.org/topics/drug-hypersensitivity-syndrome/ (accessed 6 May 2021).