Postmarketing Colitis Cases Associated With Alpelisib Use Reported to the US Food and Drug Administration

被引:3
|
作者
Sullivan, Kathleen M. [1 ]
Dores, Graca M. [1 ]
Nayernama, Afrouz [1 ]
Prowell, Tatiana M. [2 ,3 ]
Pradhan, Shan M. [2 ]
Osgood, Christy [2 ]
Jones, S. Christopher [1 ]
机构
[1] US FDA, Div Pharmacovigilance, Off Surveillance & Epidemiol, Ctr Drug Evaluat, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA
[2] US FDA, Off Oncol Dis, Ctr Drug Evaluat, Silver Spring, MD USA
[3] Johns Hopkins Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA
关键词
D O I
10.1001/jamaoncol.2022.3249
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
引用
收藏
页码:1503 / 1505
页数:4
相关论文
共 50 条
  • [1] Power Morcellators, Postmarketing Surveillance, and the US Food and Drug Administration
    Redberg, Rita F.
    Jacoby, Alison F.
    Sharfstein, Joshua M.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 318 (04): : 325 - 326
  • [2] Characteristics of Drug-Associated Rhabdomyolysis: Analysis of 8,610 Cases Reported to the US Food and Drug Administration
    Oshima, Yasuo
    INTERNAL MEDICINE, 2011, 50 (08) : 845 - 853
  • [3] US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018
    Skydel, Joshua J.
    Zhang, Audrey D.
    Dhruva, Sanket S.
    Ross, Joseph S.
    Wallach, Joshua D.
    CLINICAL TRIALS, 2021, 18 (04) : 488 - 499
  • [4] Representativeness in Premarketing vs Postmarketing US Food and Drug Administration Trials
    Unger, Joseph M.
    JAMA NETWORK OPEN, 2021, 4 (04)
  • [5] Postmarketing Safety of Vaccines Approved by the US Food and Drug Administration A Cohort Study
    Tau, Noam
    Yahav, Dafna
    Shepshelovich, Daniel
    ANNALS OF INTERNAL MEDICINE, 2020, 173 (06) : 445 - +
  • [6] US FOOD AND DRUG ADMINISTRATION (FDA) POSTMARKETING REQUIREMENTS AND COMMITMENTS RELATED TO DRUG DISPOSITION IN LACTATION AND PREGNANCY
    Ridge, S.
    Ramamoorthy, A.
    Guinn, D.
    Zineh, I.
    Fletcher, E. Pfuma
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023, 113 : S77 - S77
  • [7] Retrospective analysis of dermatologic adverse events associated with hydroxychloroquine reported to the US Food and Drug Administration
    Lipner, Shari R.
    Wang, Yu
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2020, 83 (05) : 1527 - 1529
  • [8] Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications
    Desai, Ravi J.
    Good, Meghan M.
    San-Juan-Rodriguez, Alvaro
    Henriksen, Andrew
    Cunningham, Francesca
    Hernandez, Inmaculada
    Good, Chester B.
    JAMA NETWORK OPEN, 2019, 2 (09)
  • [9] The Food and Drug Administration Amendments Act and Postmarketing Commitments
    Fain, Kevin
    Daubresse, Matthew
    Alexander, G. Caleb
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 310 (02): : 202 - 204
  • [10] Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020
    Moneer, Osman
    Lee, ChangWon C.
    Avorn, Jerry
    Kesselheim, Aaron S.
    JAMA NETWORK OPEN, 2021, 4 (04)