Bibliographic record
Abstract
The undersigned submits this petition to request the Commissioner of Food and Drugs to immediately require the addition of boxed warnings, warnings, precautions, and highlights of prescribing information to the product label for all selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) products, including branded and generic formulations.These include, but are not limited to, citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fl uoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor), and vortioxetine (Trintellix). A. Action requestedRequire the immediate revision of all SSRI and SNRI product labels (including branded and generic formulations) to warn of serious and severe risks, as follows: 1. Add WARNINGS, PRECAUTIONS, and HIGHLIGHTS OF PRESCRIBING INFORMATION to inform that the use of and withdrawal from SSRIs and SNRIs can result in genital anesthesia, pleasureless or weak orgasm, delayed or absent orgasm, loss of libido, erectile dysfunction, decreased vaginal lubrication, reduced nipple sensitivity, fl accid glans penis during erection, reduced response to sexual stimuli, and decreased capacity to experience sexual pleasure.2. Add WARNINGS, PRECAUTIONS, and HIGHLIGHTS OF PRESCRIBING INFORMATION to inform that the use of and withdrawal from SSRIs and SNRIs can result in persistent genital arousal disorder (PGAD).3. Add WARNINGS, PRECAUTIONS, HIGHLIGHTS OF PRESCRIBING INFORMATION, and a BOXED WARNING to inform that sexual side effects can sometimes persist for years or indefi nitely after discontinuation of the drug; they can emerge on treatment and remain afterwards, or emerge or worsen when the drug is stopped.4. Send all manufacturers of SSRIs and SNRIs a notifi cation letter of the need for a Risk Evaluation and Mitigation Strategy Plan to include the following: i. Require manufacturers to send a Dear Health Care Provider Letter to psychiatrists, psychologists, internists, family practitioners, urologists and endocrinologists that informs the health care providers that the drug has serious adverse reactions associated with its use, and poses a signifi cant public health concern.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.003 | 0.009 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.005 | 0.002 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.030 | 0.016 |
| Insufficient payload (model declined to judge) | 0.051 | 0.029 |
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".