Thalidomide Use in the US

Uhl, Kathleen; Cox, Edward; Rogan, Rose; Zeldis, Jerome B.; Hixon, Dena; Furlong, Lesley-Anne; Singer, Sarah J.; Holliman, Tracy; Beyer, Joanne; Woolever, William

doi:10.2165/00002018-200629040-00003

Cited by 54 publications

(17 citation statements)

References 10 publications

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“…Thalidomide use is carefully monitored using successful schemes like the S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety_program (Zeldis et al, 1999; Uhl et al, 2006), which monitors patients to ensure they are not pregnant while receiving treatment.…”

Section: Part One: History and Thalidomide Embryopathymentioning

confidence: 99%

Thalidomide‐induced teratogenesis: History and mechanisms

Vargesson

2015

Birth Defects Research Pt C

694

557

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Nearly 60 years ago thalidomide was prescribed to treat morning sickness in pregnant women. What followed was the biggest man‐made medical disaster ever, where over 10,000 children were born with a range of severe and debilitating malformations. Despite this, the drug is now used successfully to treat a range of adult conditions, including multiple myeloma and complications of leprosy. Tragically, a new generation of thalidomide damaged children has been identified in Brazil. Yet, how thalidomide caused its devastating effects in the forming embryo remains unclear. However, studies in the past few years have greatly enhanced our understanding of the molecular mechanisms the drug. This review will look at the history of the drug, and the range and type of damage the drug caused, and outline the mechanisms of action the drug uses including recent molecular advances and new findings. Some of the remaining challenges facing thalidomide biologists are also discussed. Birth Defects Research (Part C) 105:140–156, 2015. © 2015 The Authors Birth Defects Research Part C: Embryo Today: Reviews Published by Wiley Periodicals, Inc.

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Section: Part One: History and Thalidomide Embryopathymentioning

confidence: 99%

Thalidomide‐induced teratogenesis: History and mechanisms

Vargesson

2015

Birth Defects Research Pt C

694

557

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“…The approvals of lenalidomide and thalidomide were achieved in a different regulatory environment from that of the 1950s and 1960s and, in tandem with approval of these drugs, systems were implemented to prevent fetal exposure [13, 14]. Since the 2007 FDA Amendments Act, the FDA has required sponsors of new drug applications (NDAs), biologics license applications (BLAs), generic and biosimilar applications to submit a risk evaluation and mitigation strategies (REMS) program if there is concern that the risks of the product cannot be addressed by routine product labelling.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention

Brandenburg¹,

Bwire²,

Freeman³

et al. 2017

Drug Saf

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IntroductionThe effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages.MethodsResults from mandatory knowledge, attitude, and behavior surveys and voluntary patient surveys completed between June 2012 and June 2013 were analyzed, and responses to questions relating to compliance with birth control measures and understanding of safe-use messages are presented by patient risk category.ResultsIn total, 73,645 patients were enrolled into the REMS programs for lenalidomide and thalidomide and completed mandatory surveys prior to medication dispense. Of these, 2790 (3.8%) completed an additional voluntary survey. Among voluntary survey participants, for all patient pregnancy risk categories, reported compliance with birth control requirements was above 90% when starting therapy and at follow-up. At the beginning of therapy, complete compliance was 96.3%; 3 months later it was 96.4%. Patient understanding of safe-use messages was very high in all pregnancy risk groups, notably for messages repeated at each physician visit. Overall, 98.2% of patients knew that lenalidomide and thalidomide could cause birth defects, which is part of the repeated educational messaging. In contrast, 87.1% recalled that unused product should be returned to their healthcare professional, which is not included in repeated messaging.ConclusionThe lenalidomide and thalidomide REMS programs enhance patient understanding of safe-use messages, resulting in high levels of compliance with the birth control precautions essential to prevent fetal exposure to these known and potential human teratogens. Overall compliance was maintained after 3 months of follow-up and throughout therapy.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-016-0501-2) contains supplementary material, which is available to authorized users.

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“…There has been at least one case report of elevated b hCG in a nongravid, premenopausal patient with MM, where immunochemical investigations demonstrated that myeloma cells expressed immunoreactive b hCG, which may explain the positive pregnancy test results in a nongravid woman [12]. In a US study of the thalidomide S.T.E.P.S program, positive pregnancy tests were registered in 72 out of the~6000 FCBPs, with 69 (95.8%) of these tests found to be false positives [13].…”

Section: Target Risk Population and Monitoringmentioning

confidence: 99%

“…According to the current EU guideline [13], the need for additional educational material and the form in which it should be provided depend on the safety concern. Celgene has developed additional educational materials for the pregnancy prevention program, detailing the teratogenic risk of thalidomide and lenalidomide and the steps that must be in place to mitigate the risk of fetal exposure.…”

Section: Updating Additional Educational Materialsmentioning

confidence: 99%

Managing the teratogenic risk of thalidomide and lenalidomide: an industry perspective

Bwire¹,

Freeman²,

Houn³

2010

Expert Opinion on Drug Safety

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Celgene has developed and operated pregnancy prevention programs since 1998 with the first approval of thalidomide in the US. With the development and marketing of lenalidomide, an analog of thalidomide, the company further advanced its risk management activities, which now cover several territories across the globe. To date, the program is a success in as much as it has minimized the risk of fetal exposure and subsequent development of fetal malformations. Nonetheless, the company understands the need to provide a mechanism for intervention and remediation when at-risk behaviors are identified, and this forms an integral part of the risk management processes. The implementation of the thalidomide and lenalidomide pregnancy prevention program partners patients, healthcare professionals, regulators and the company in a spirit of shared responsibility. This paper also presents the authors' experience and perspective on the challenges of managing a pregnancy prevention program, which at its core aims at ensuring that the product's benefits outweigh the risk of fetal exposure.

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Thalidomide Use in the US

Cited by 54 publications

References 10 publications

Thalidomide‐induced teratogenesis: History and mechanisms

Thalidomide‐induced teratogenesis: History and mechanisms

Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention

Managing the teratogenic risk of thalidomide and lenalidomide: an industry perspective

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