1031 ISOTRETINOIN (13-CIS RETINOIC ACID) IS ASSOCIATED WITH A HIGHER FREQUENCY OF SLEEP APNEA SYNDROME: RESULTS FROM THE US FDA ADVERSE EVENT REPORTING SYSTEM (FAERS)
Bibliographic record
Abstract
Isotretinoin (13-cis retinoic acid)(ISO) is a synthetic oral retinoid used mainly for the treatment of nodulocystic acne and some other dermatologic disorders. Retinoic acid plays an important role in the regulation of several biological rhythms including sleep. There are no population-based studies of sleep symptoms associated with ISO use. We examined the FAERS database (Jan 2004 - March 2016) for sleep-related adverse events (AE) when ISO was used for (i) for all indications, and (ii) acne alone. Medical Dictionary for Regulatory Activities preferred terms (PT) was searched to identify Individual Safety Reports (ISR) where ISO was documented as the primary suspect for the sleep-related AE. Reporting odds ratios (ROR) with 95% CI were calculated to indicate the strength of the signal for the sleep-related AE from ISO use. There were 168,341 ISR which specified ISO as the primary suspect in the AE. The overall risk of sleep-related AE with ISO was examined in 2 analyses: (i) ISO used for any indication versus ‘all other drugs’ in FAERS revealed the following: 106 ISR reporting ‘sleep apnea syndrome’(SA) with ISO among 168,235 total AE reported with ISO, versus 9,442 ISR reporting SA with ‘all other drugs’ among 23,294,181 total AE reported with ‘all other drugs’ [ROR=1.55 (95% CI 1.28–1.88), p<0.0001]. The ROR for the following sleep-related AE were lower with ISO versus ‘all other drugs’: Hypersomnia ROR=0.37 (95% CI 0.32–0.42), p<0.001; Insomnia ROR=0.86 (95% CI 0.80–0.92), p<0.001; Nightmare ROR=0.19 (95% CI 0.13–0.3), p<0.001. (ii)ISO used for acne alone versus ‘all other acne treatments’ revealed the following: 100 ISR reporting SA with ISO among 150,424 total all other AE with ISO versus 1 ISR reporting SA with ‘all other acne treatments’ among 210,104 total AE with ‘all other acne treatments’ [ROR=139.69 (95% CI 18.65–958.42), p<0.0001]. RORs for all other sleep-related AE were non-significant. National pharmacovigilance data indicate a significantly higher frequency of sleep apnea with ISO when compared to all other drugs; the increased frequency was mainly among patients using ISO for acne. This previously unreported finding needs to be followed up with clinical studies. None
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.015 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.002 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".