Reported Adverse Drug Reaction Cases
Reports of hypersensitivity reactions to pregabalin
Case Report: Four and a half hours after her first dose of pregabalin for neuropathic pain, a woman woke during the night with breathing difficulty due to a swollen face, neck and tongue. She required emergency treatment with adrenaline, promethazine and prednisone before making a full recovery.
Pregabalin (Lyrica) is approved for use in the treatment of neuropathic pain in adults and as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Post-marketing reports of hypersensitivity reactions to pregabalin comprise 13% of all the pregabalin adverse reaction reports in the ADRAC database, with a range of symptoms reported in 22 individuals (14F:8M). Presentations have included anaphylaxis and 7 reports of allergic skin rash. The others were angioedema of eyelids, tongue, mouth, face, lips or upper airway, with breathing difficulty when severe and widespread.
Of the 22 cases, 6 women developed symptoms within hours of their first dose of pregabalin. In 14 of the cases, pregabalin was the sole suspected drug. Four patients required emergency treatment, including adrenaline and/or parenteral steroids and IM or oral antihistamine. Three of the cases of skin reaction were confirmed by a positive dechallenge and subsequent rechallenge. There is insufficient information about the patients' histories of atopy or other allergies to comment on the predictive value of such a history.
The pregabalin Product Information includes a contraindication for patients who have demonstrated hypersensitivity to pregabalin or to any of the excipients.
Pregabalin prescribers should be alert to the fact that acute allergic reactions may present early after its introduction and after any dose increases, and counsel patients accordingly.
The Australian Adverse Drug Reactions Bulletin, Volume 26, Number 6 (December 2007)