VSI Fall 2021 Newsletter

Bibliography and Sources

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Bonner, L. CDC report calls attention to hand sanitizer risk in children. Pharmacy Today. Issue 5, 35. 2017 May 01.
https://www.pharmacytoday.org/article/S1042-0991(17)30602-3/fulltext

Cleveland HeartLab. The Cardiac Risks of Rheumatoid Arthritis. ClevelandHeartlab.com. 2017 Aug 7.
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ClinicalTrials.Gov. Safety Study of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02092467

Coyle CH, Kader KN. Mechanisms of H2O2-induced oxidative stress in endothelial cells exposed to physiologic shear stress. ASAIO Journal. 2007, Jan-Feb: 53(1) 17-22. https://pubmed.ncbi.nlm.nih.gov/17237644/

FDA. FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions: Approved uses also being limited to certain patients. FDA.gov. 2021 Sept 1.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death

Fitzhugh M. Incyte wins FDA approval for ruxolitinib cream in AD, with class-related boxed warnings. BioWorld. 2021 Sept 21. https://www.bioworld.com/articles/511644-incyte-wins-fda-approval-for-ruxolitinib-cream-in-ad-with-class-related-boxed-warnings?v=preview

Hernández NF, Sánchez GM, Cedeño Palenzuela, ME. Function of hydrogen peroxide in cases of vitiligo. Revista Cubana de Farmacia. 44(3):390-402. 2010 July. https://www.researchgate.net/publication/286538576_Function_of_hydrogen_peroxide_in_cases_of_vitiligo

Incyte. Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD). Press Release. 2021 Sept. 21.
https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-U.S.-FDA-Approval-of-Opzelura-ruxolitinib-Cream-a-Topical-JAK-Inhibitor-for-the-Treatment-of-Atopic-Dermatitis-AD/default.aspx

Laday J. ‘We need to see the data’: FDA’s Xeljanz safety warning stirs concerns for JAK inhibitors. Healio News. 2021 Feb 16. https://www.healio.com/news/rheumatology/20210215/we-need-to-see-the-data-fdas-xeljanz-safety-warning-stirs-concerns-for-jak-inhibitors

Losavio K. FDA Requires New Boxed Warnings on JAK Inhibitors, Places Restrictions on Use. The Rheumatologist. 2021 Sept 1.
https://www.the-rheumatologist.org/article/fda-requires-new-boxed-warnings-on-jak-inhibitors-places-restrictions-on-use/

Mack Z, If You Take This Popular Medication, Talk to Your Doctor Now, FDA Says. BestLife. 2021 September 3. https://bestlifeonline.com/news-xeljanz-fda/

Nandi A., Yan LJ. Jana CK, Das N. Role of Catalase in Oxidative Stress- and Age-Associated Degenerative Diseases. Oxidative Medicine and Cellular Longevity. 2019: 9613090. 2019 Nov 11. https://www.hindawi.com/journals/omcl/2019/9613090/

Petronelli M. FDA Requiring Black Box Warning for Certain JAK Inhibitors. Dermatology Times. 2021 Sept 2.
https://www.dermatologytimes.com/view/fda-requiring-black-box-warning-for-certain-jak-inhibitors

Rovenstine R. What is a black box warning? The Checkup by SingleCare. 2020 April 10.
https://www.singlecare.com/blog/black-box-warning/

Stott R. FDA adds black box warning to JAK inhibitors; cites heart-related issues, cancer, death. Healio News. (Additional perspective by Calabrese L, Cohen S, Laster A). 2021 Sept 1.
https://www.healio.com/news/rheumatology/20210901/fda-adds-black-box-warning-to-jak-inhibitors-cites-heartrelated-issues-cancer-death