The Health Sciences Authority (HSA) has received reports of severe cutaneous adverse reactions (SCARs), specifically Stevens-Johnson syndrome (SJS), associated with the usage of modafinil and armodafinil. It is noteworthy that patients in these cases acquired the medications through informal channels such as friends or illegal street vendors.
Modafinil and armodafinil are commonly prescribed for conditions characterized by excessive somnolence, such as narcolepsy and obstructive sleep apnea. Although these medications are not officially registered in Singapore, they can be imported and distributed locally under the special access route (SAR).
Stevens-Johnson Syndrome (SJS) Cases with Modafinil and Armodafinil:
1. Local Incidents: As of October 31, 2023, HSA has received nine Adverse Event (AE) reports related to modafinil and armodafinil. Of these, seven reports (77.8%) involved dermatological/cutaneous reactions, with three cases specifically identified as SJS. The remaining two reports detailed symptoms of increased paranoia and giddiness. Notably, four patients sourced the medications from friends or unauthorized street vendors, with three self-medicating for heightened alertness at work. The three SJS cases involved individuals in their thirties, comprising two males and one female, and the onset of SJS varied from one day to over one month. Modafinil was implicated in two cases, while armodafinil was linked to the third case.(Other reported reactions included a generalized pruritic rash, angioedema, skin and oral ulcers, fixed drug eruption manifested as oral erosions, and three cases of SJS.)
2. Clinical Trial Insights and International Reports: The incidence of SJS associated with modafinil and armodafinil is not precisely established. In modafinil clinical trials, the rate of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) among pediatric patients (age <17 years). These reports included one case of possible SJS and one case of an apparent multi-organ hypersensitivity reaction.While rare, serious or life-threatening skin reactions, including SJS, Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), have been documented in global post-marketing experiences with modafinil and armodafinil. The reporting rate of TEN and SJS worldwide exceeds the expected background incidence rate. Background incidence rates for these severe skin reactions in the general population are estimated to range between 1 to 2 cases per million-person years. Given the occurrence of three SJS cases locally despite the limited usage of these medications, heightened vigilance and monitoring are recommended.
Conclusion: HSA has issued two press releases, the first in 2018 and the second in November 2023, to inform the public about serious adverse reactions, including SJS, associated with modafinil and armodafinil. The recent press release followed the receipt of three serious reports (2 SJS and 1 fixed drug eruption requiring hospitalization) over a three-month period.
Healthcare professionals are advised to consider the possibility of severe cutaneous adverse reactions (SCARs) in patients exhibiting prodromal symptoms such as flu-like symptoms, mouth ulcers, sore throat, and conjunctivitis. Reporting of any adverse events, especially SCARs suspected with these medications, is encouraged, and healthcare professionals are urged to provide information on the source of the medication if available, particularly if obtained from unauthorized sources.
HSA: Health Sciences Authority; SJS: Stevens-Johnson syndrome; SCARs: severe cutaneous adverse reactions; SJS: Stevens-Johnson syndrome; AE: Adverse Event
Link to the original news article:
https://www.hsa.gov.sg/announcements/safety-alert/severe-cutaneous-adverse-reaction-reports-with-modafinil-and-armodafinil
Links to the November press release:
https://www.straitstimes.com/singapore/three-men-hospitalised-after-taking-modafinil-or-armodafinil-to-stay-awake-drugs-were-not-prescribed
https://www.channelnewsasia.com/singapore/hsa-alert-modafinil-armodafinil-three-men-hospitalised-after-taking-unregistered-medicines-3899791
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