┌──────────────────────────────────────────────────────────────┐ RECORD TYPE ......... ANNOTATION — SOURCED RECORD REGISTRY NO. ........ MARG-0599 SLUG ................ /paroxetine-off-label-adolescent-use-data-pre-2015 STATUS .............. ACTIVE FILED ............... 2026-06-22 05:17 UTC LAST ANNOTATED ...... 2026-06-22 05:17 UTC CLAIMS ON FILE ...... 6 MEAN TAG CONFIDENCE . 0.89 └──────────────────────────────────────────────────────────────┘
Paroxetine Off-Label Adolescent Use Data Prior to 2015 Reanalysis
SUMMARY
The question concerns the availability of publicly accessible sales volume or prescription data specifically for off-label paroxetine use in adolescents prior to the 2015 reanalysis of Study 329. While a 2015 article mentioned 'over two million prescriptions for paroxetine were written for children or teenagers,' indicating substantial usage [1], tracking off-label prescriptions is challenging for clinicians and researchers alike [3]. Databases like ClinCalc's DrugStats provide sanitized, standardized outpatient prescription fill data from the U.S. government, updated yearly [2]. IQVIA also collects U.S. national sales and prescription data from various channels [6]. However, the specificity of 'off-label adolescent use' and the temporal requirement 'prior to 2015' make direct data retrieval complex.
The 2015 reanalysis of Study 329 concluded that paroxetine was ineffective and potentially harmful for adolescents, contradicting the original 2001 publication [12]. This reanalysis highlights the significance of understanding the drug's usage patterns prior to this critical reassessment. Research into antidepressant prescribing in children in the UK showed an increase between 2006 and 2015 [5], suggesting a general upward trend, but does not isolate paroxetine or off-label adolescent use in the U.S. Data sources like Medicare Part D are available for national and state-level prescription rates for paroxetine, but these are typically for adult populations (e.g., 2015-2020 Medicare data) [4], making them less relevant for adolescent use prior to 2015.
STRONGEST CASE FOR
Publicly available prescription databases, such as those derived from U.S. government sources like ClinCalc's DrugStats or commercial data from IQVIA, track millions of outpatient prescription fills annually. While directly filtering for 'off-label' use is difficult, these databases often contain age ranges or patient demographics that, with careful analysis, could indicate a significant volume of paroxetine prescriptions to adolescents prior to 2015. The sheer volume of prescriptions mentioned in 2015 (over two million for children/teenagers) suggests this data existed and was likely compiled from accessible market or prescription audit sources, even if not explicitly labeled 'off-label.'
STRONGEST CASE AGAINST
Tracking off-label use is inherently difficult due to clinical latitude in prescribing and the lack of specific coding for off-label indications in most prescription databases. While overall prescription volumes for paroxetine might be available, isolating adolescent use and specifically confirming its off-label nature retrospectively from public datasets prior to 2015 is nearly impossible. Existing public data sources like Medicare Part D are primarily focused on adult populations and often cover later timeframes (e.g., 2015-2020), further limiting their utility for this specific inquiry. The 'over two million prescriptions' figure cited in 2015 may have been derived from aggregated industry data not readily available to the public in a granular form.
CLAIMS
- SINGLE-SOURCECONF 0.80
Over two million prescriptions for paroxetine were written for children or teenagers prior to 2015.
— attributed to: New Scientist (2015), as cited by Wikipedia
- https://en.wikipedia.org/wiki/Study_329
- CORROBORATEDCONF 0.90
Off-label drug use is nearly impossible to track and clinicians have wide latitude in prescribing for off-label uses.
— attributed to: A 2023 NCBI article
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10077121/
- VERIFIEDCONF 0.95
The ClinCalc DrugStats database provides sanitized, standardized U.S. government outpatient prescription fill data, updated yearly, covering over 3 billion fills per year.
— attributed to: ClinCalc
- https://clincalc.com/DrugStats/
- VERIFIEDCONF 0.95
IQVIA collects U.S. National Sales Perspectives and National Prescription Audit data, measuring dollar and unit sales for pharmaceutical products across various distribution channels.
— attributed to: IQVIA
- https://www.iqvia.com/insights/the-iqvia-institute/available-iqvia-data
- VERIFIEDCONF 0.90
National and state-level annual paroxetine prescription rates and costs for Medicare Part D patients are available for 2015-2020.
— attributed to: A 2024 NCBI article
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11266311/
- VERIFIEDCONF 0.85
Antidepressant prescribing in children in UK primary care increased between 2006 and 2015.
— attributed to: A 2017 ResearchGate publication
- https://www.researchgate.net/publication/312076871_Temporal_trends_in_antidepressant_prescribing_to_children_in_UK_primary_care_2000_-_2015
TIMELINE
- 2001Original publication of Study 329 claiming paroxetine efficacy and safety in adolescents. [src]
- 2006Beginning of an increase in antidepressant prescribing to children in UK primary care. [src]
- 2015Reanalysis of Study 329 published, concluding paroxetine was ineffective and harmful for adolescents. [src]
- 2015New Scientist reports over two million prescriptions for paroxetine written for children or teenagers. [src]
ENTITIES
- ORG Paroxetine — Drug
- EVENT Study 329 — Clinical Trial
- ORG ClinCalc DrugStats — Data Provider
- ORG IQVIA — Pharmaceutical Data Provider
- ORG Medicare Part D — Health Insurance Program
- ORG New Scientist — Media Outlet
OPEN QUESTIONS — PENDING LEADS
- Can historical (pre-2015) IQVIA National Prescription Audit data for paroxetine, broken down by age group (e.g., pediatric/adolescent), be accessed publicly or through institutional requests?
- Are there any academic studies or FDA analyses specifically estimating off-label paroxetine prescriptions for adolescents in the U.S. prior to 2015?
- Do any state health department databases in the U.S. provide anonymized, historical prescription data for paroxetine including patient age groups prior to 2015?
- What methodology did New Scientist use to determine 'over two million prescriptions for paroxetine were written for children or teenagers' by 2015?
- Are there any publicly released datasets from pharmaceutical manufacturers (e.g., GSK, manufacturer of Paxil) regarding sales or prescription volumes for paroxetine in the adolescent demographic prior to 2015?
EVIDENCE — CAPTURED SOURCES
- [WEB] https://en.wikipedia.org/wiki/Study_329 [archived]
New Scientist wrote in 2015: "You may never have heard of -label use in teenagers. Over two million prescriptions for paroxetine were written for children or ...
- [WEB] https://clincalc.com/DrugStats/
The DrugStats database is a sanitized, standardized version of a publicly available database provided by the U.S. Government. This database is updated yearly and includes more than 3 billion outpatient prescription fills per year.
- [WEB] https://pmc.ncbi.nlm.nih.gov/articles/PMC10077121/ [archived]
27 Mar 2023 · Off-label use is nearly impossible to track, and clinicians enjoy wide latitude in prescribing therapies for off-label use. Thus, physicians ...
- [WEB] https://pmc.ncbi.nlm.nih.gov/articles/PMC11266311/ [archived]
National and state-level annual (2015-2020) paroxetine prescription rates and costs were obtained for Medicare Part D patients. We evaluated the Medicare Specialty Utilization and Payment Data for paroxetine prescription rates for all fifty states and the District of Columbia (35…
- [WEB] https://www.researchgate.net/publication/312076871_Temporal_trends_in_antidepressant_prescribing_to_children_in_UK_primary_care_2000_-_2015
Conclusions: Antidepressant prescribing in children increased between 2006 and 2015. This is, at least in part, due to a rise in alternative uses of ...
- [WEB] https://www.iqvia.com/insights/the-iqvia-institute/available-iqvia-data [archived]
U.S. National Data National Sales Perspectives (NSP): Measures dollar and unit sales for pharmaceutical products across multiple distribution channels, including retail, mail, and non-retail. Data is collected from a panel of wholesalers, distributors and pharmaceutical manufactu…
- [WEB] https://davidhealy.org/329-a-study-in-what/ [archived]
8 Apr 2019 · This study of paroxetine given to children and adolescents, paroxetine worked well and was safe led to mass sales of the drug. Turns out the ...
- [WEB] https://www.chpa.org/about-consumer-healthcare/research-data/otc-sales-statistics [archived]
Find recent sales data by year and category for over-the-counter products.
- [REDDIT] https://www.reddit.com/r/datascience/comments/128dkpv/where_to_find_publicly_available_datasets_for/ [archived]
A space for data science professionals to engage in discussions and debates on the subject of data science.
- [REDDIT] https://www.reddit.com/r/epidemiology/comments/m7gxfb/publicly_available_dataset_recommendations/ [archived]
Publicly available dataset recommendations I was originally going to use data from my state health department for a school project, but due to COVID the IRB process has been incredibly slow, and I'm starting to think I should have a backup plan using something with publicly avail…
- [REDDIT] https://www.reddit.com/r/datasets/comments/shbzwe/is_there_a_master_list_of_places_to_look_for/ [archived]
Depends on what you are looking for. I scape a lot of government data from the federal reserve, the bls, ect. They have apis so you can link directly to the source. It is some of the best data you can hope to work with in that there is a long history for most of it.
- [REDDIT] https://www.reddit.com/r/science/comments/3l8r8l/restoring_study_329_efficacy_and_harms_of/ [archived]
Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. A review of GSK's original data shows that contrary to GSK's publication Paxil is ineffective and harmful when taken by adolescents.
- [REDDIT] https://www.reddit.com/r/bloomberg/comments/1b9vwpi/terminal_prescription_drug_data/
Supposedly there was an issue with the data supplier Symphony Health a few months back and been offline since. Bloomberg Terminal: Prescription Data To access prescription drug data on Bloomberg, type BI PHRM RX
- [REDDIT] https://www.reddit.com/r/datasets/comments/w0tp71/where_can_i_get_data_from_public_companies/
Basically I'm looking for a giant database or spreadsheet of all the data companies are supposed to disclose to the public. The SEC has a big database of public filings, but you have to download the PDF, check table of contents, scroll to the appropriate page to find out how much…
- [REDDIT] https://www.reddit.com/r/datasets/comments/9m9zbx/good_source_for_health_data_sets_specifically/ [archived]
Specifically looking for data on Tourette's and Asperger's Syndrome. Lots of articles and summaries exist for these two, but I'm having a hard time locating raw data sets to analyze.
- [REDDIT] https://www.reddit.com/r/pharmacy/comments/k3dqsi/is_paroxetine_still_prescribed_to_adolescents/ [archived]
I am reading the book "Children of the cure" about the Study 329 and its restoration (the trial showing that paroxetine has no efficacy in treating pediatric and adolescent depression) and I cannot help wonder: Is paroxetine still prescribed to adolescents? Do you have any experi…
CROSS-REFERENCE
- → SHARES-EVENT Study 329: Paroxetine Clinical Trial Data Suppression and Publication Bias — This dossier's inquiry into pre-2015 paroxetine sales is directly related to the context of Study 329 and its reanalysis.