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Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014.
Clin Pharmacol Ther. 2018 08; 104(2):390-400.CP

Abstract

We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 years. At least one safety-related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow-up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast-track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drug's lifecycle and for practitioners and patients to remain updated on drug safety profiles.

Authors+Show Affiliations

Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA. University of Maryland Marlene and Stuart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore, Maryland, USA.Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA. University of Maryland Marlene and Stuart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore, Maryland, USA.Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29266187

Citation

Pinnow, Ellen, et al. "Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved By the Food and Drug Administration Between 2002 and 2014." Clinical Pharmacology and Therapeutics, vol. 104, no. 2, 2018, pp. 390-400.
Pinnow E, Amr S, Bentzen SM, et al. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014. Clin Pharmacol Ther. 2018;104(2):390-400.
Pinnow, E., Amr, S., Bentzen, S. M., Brajovic, S., Hungerford, L., St George, D. M., & Dal Pan, G. (2018). Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014. Clinical Pharmacology and Therapeutics, 104(2), 390-400. https://doi.org/10.1002/cpt.944
Pinnow E, et al. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved By the Food and Drug Administration Between 2002 and 2014. Clin Pharmacol Ther. 2018;104(2):390-400. PubMed PMID: 29266187.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014. AU - Pinnow,Ellen, AU - Amr,Sania, AU - Bentzen,Søren M, AU - Brajovic,Sonja, AU - Hungerford,Laura, AU - St George,Diane Marie, AU - Dal Pan,Gerald, Y1 - 2017/12/20/ PY - 2017/12/22/pubmed PY - 2019/9/10/medline PY - 2017/12/22/entrez SP - 390 EP - 400 JF - Clinical pharmacology and therapeutics JO - Clin. Pharmacol. Ther. VL - 104 IS - 2 N2 - We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 years. At least one safety-related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow-up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast-track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drug's lifecycle and for practitioners and patients to remain updated on drug safety profiles. SN - 1532-6535 UR - https://www.unboundmedicine.com/medline/citation/29266187/Postmarket_Safety_Outcomes_for_New_Molecular_Entity__NME__Drugs_Approved_by_the_Food_and_Drug_Administration_Between_2002_and_2014_ L2 - https://doi.org/10.1002/cpt.944 DB - PRIME DP - Unbound Medicine ER -