ArticleDrug safety2008
RevAssist: a comprehensive risk minimization programme for preventing fetal exposure to lenalidomide.
Article in Drug safety, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.British journal of clinical pharmacology · 2018Pooled it
- Pomalidomide is active in the treatment of anemia associated with myelofibrosis.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009Trial
- Article
- Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide.Therapeutic innovation & regulatory science · 2021Review
- Risk Evaluation and Mitigation Strategies (REMSs): Are They Improving Drug Safety? A Critical Review of REMSs Requiring Elements to Assure Safe Use (ETASU).Drugs in R&D · 2017Review
- Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention.Drug safety · 2017Article
- Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation.Drug safety · 2014Review
- Trial Watch: Lenalidomide-based immunochemotherapy.Oncoimmunology · 2013Review
- Risk minimization activities of centrally authorized products in the EU: a descriptive study.Drug safety · 2012Article
- Lenalidomide therapy in treatment-refractory cutaneous lupus erythematosus: histologic and circulating leukocyte profile and potential risk of a systemic lupus flare.Journal of the American Academy of Dermatology · 2012Article
- The use of novel agents in the treatment of relapsed and refractory multiple myeloma.Leukemia · 2009Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lenalidomide (Revlimid) is an immunomodulatory drug and an analogue of thalidomide, a known teratogen. To prevent fetal exposure, in the US lenalidomide is available only under a special restricted distribution programme called RevAssist. Under this risk minimization programme, only prescribers and contract pharmacies registered with the programme are able to prescribe and dispense the product. Patients must be advised of, agree to and comply with the requirements of the RevAssist programme in order to receive lenalidomide through a registered prescriber. A total of 15 584 patients were registered in the RevAssist programme during the first year lenalidomide was on the market. There were four reports of false-positive beta-human chorionic gonadotrophin measurements in patients aged 43-57 years. Mandatory patient and prescriber surveys have shown discrepant responses that were resolved by risk management intervention specialists 99% of the time. The voluntary patient surveys have shown understanding of the risks of lenalidomide use and of behaviours necessary to minimize risks in >95% of females of childbearing potential and adult males. To date, there have been no reports of pregnancy in female patients or female partners of male patients. The pharmacy audit findings showed compliance with RevAssist was high. Although RevAssist is labour-intensive, time-consuming and costly, it continues to be effective in preventing fetal exposure to lenalidomide.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.