Monthly ArchiveFebruary 2019

Oncologic Drugs Advisory Committee Roster

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This page contains the ODAC roster, which lists the current members and the current number of vacancies for the committee. …

Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate

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Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate …

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication – Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

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FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis …

Planned Parenthood President Leana Wen On Trump Administration Title X Changes

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NPR’s Lulu Garcia-Navarro talks with Leana Wen, a physician and the president of Planned Parenthood, about how a rule change from the Trump administration on Title X will affect her organization. …

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

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FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) …

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

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The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information. …

Drugs@FDA Download File (new structure)

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Drugs@FDA Data files updated weekly …

Additions/Deletions for Prescription and OTC Drug Product Lists

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The list has been updated through December 2017. …

Americans Tightened Their Belts And It Might Hurt Economic Numbers Important To Trump

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Retail sales fell 1.2 percent in December, the most in nine years. The drop cut into forecasts for economic growth. David Zalubowski/AP hide caption toggle caption David Zalubowski/AP Retail sales fell 1.2 percent in December, the most in nine years. The drop cut into forecasts for economic growth. David Zalubowski/AP

Newly Added Guidance Documents

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Guidance documents represent the FDA’s current thinking on a particular subject. New guidance documents are listed here for three months. …

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