© 2004 Canadian Medical Association or its licensors Generic isotretinoin: a new risk for unborn children
Bibliographic record
Abstract
The introduction of isotretinoin (Accutane) in 1982 was a milestone in the treatment of recalcitrant nodular acne. Although the severe teratogenic effects of the drug quickly became evident,1 its use rapidly increased and was inappropriately extended to patients with less severe forms of acne.2,3 Of 1000 patients who participated in an international survey in 1997, 45 % did not have the labelled indication for the drug.4 Also, new off-label uses have emerged, including treatment of dermatologic conditions such as gram-negative folliculitis, recalcitrant rosacea, pyoderma faciale, generalized lichen planus, psoriasis, cutaneous lupus erythematosus and acne fulminans5 —as well as, more recently, the treatment of squamous cell carcinomas6and leukemias.7 Pre-market studies in animals showed high rates of central nervous system and facial malformation after gestational exposure; indeed, within months of the introduction of isotretinoin into the market, severe malformations reported in infants of women taking the drug revealed that it is a potent human teratogen.8 Box 1 presents the features of isotretinoin embryopathy. About 40 % of infants exposed
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.003 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.144 | 0.022 |
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".