Higher risk of deaths with febuxostat vs allopurinol

Higher risk of deaths with febuxostat vs allopurinol Reactions 1680, p2 - 2 Dec 2017 Higher risk of deaths with febuxostat vs allopurinol Preliminary clinical trial results show that the gout medicine febuxostat (Uloric) is linked with a greater risk of heart-related deaths and all-cause deaths versus allopurinol, says the US FDA. In a safety announcement from the FDA, it was noted that the manufacturer of Uloric (Takeda Pharmaceuticals) was asked in 2009 to conduct an additional safety clinical trial of this product. The febuxostat drug labels already carry warnings about cardiovascular (CV) events after preregistration clinical trials showed an increased rate of such heart- related problems (e.g. heart attacks, stroke, and heart- related deaths) in patients treated with febuxostat, compared with allopurinol (i.e. another gout medicine). The additional safety clinical trial of febuxostat requested by the FDA was conducted in >6000 patients with gout, and "the primary outcome was a combination of heart-related death, non-deadly heart attack, non- deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery", stated the FDA. Preliminary results from this trial showed that while febuxostat did not increase the overall risk of these combined CV-related events versus allopurinol, febuxostat was associated with an increased risk of heart-related deaths and all-cause deaths. The FDA will continue to evaluate this safety issue and plans to conduct a comprehensive review once the agency receives the final trial data from the manufacturer. The FDA will advise the public once it has more information. In the meantime, healthcare professionals are advised to consider this safety information when they consider prescribing febuxostat to their patients. In addition, patients taking febuxostat should ask their doctor if they have any concerns, but they should not stop taking the drug without first consulting their doctor. US Food and Drug Administration. FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric). Internet Document : 15 Nov 2017. Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm584702.htm 803285960 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Higher risk of deaths with febuxostat vs allopurinol

Reactions Weekly , Volume 1680 (1) – Dec 2, 2017
Free
1 page
Loading next page...
1 Page
 
/lp/springer_journal/higher-risk-of-deaths-with-febuxostat-vs-allopurinol-IIdBN89P1M
Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-38933-6
Publisher site
See Article on Publisher Site

Abstract

Reactions 1680, p2 - 2 Dec 2017 Higher risk of deaths with febuxostat vs allopurinol Preliminary clinical trial results show that the gout medicine febuxostat (Uloric) is linked with a greater risk of heart-related deaths and all-cause deaths versus allopurinol, says the US FDA. In a safety announcement from the FDA, it was noted that the manufacturer of Uloric (Takeda Pharmaceuticals) was asked in 2009 to conduct an additional safety clinical trial of this product. The febuxostat drug labels already carry warnings about cardiovascular (CV) events after preregistration clinical trials showed an increased rate of such heart- related problems (e.g. heart attacks, stroke, and heart- related deaths) in patients treated with febuxostat, compared with allopurinol (i.e. another gout medicine). The additional safety clinical trial of febuxostat requested by the FDA was conducted in >6000 patients with gout, and "the primary outcome was a combination of heart-related death, non-deadly heart attack, non- deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery", stated the FDA. Preliminary results from this trial showed that while febuxostat did not increase the overall risk of these combined CV-related events versus allopurinol, febuxostat was associated with an increased risk of heart-related deaths and all-cause deaths. The FDA will continue to evaluate this safety issue and plans to conduct a comprehensive review once the agency receives the final trial data from the manufacturer. The FDA will advise the public once it has more information. In the meantime, healthcare professionals are advised to consider this safety information when they consider prescribing febuxostat to their patients. In addition, patients taking febuxostat should ask their doctor if they have any concerns, but they should not stop taking the drug without first consulting their doctor. US Food and Drug Administration. FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric). Internet Document : 15 Nov 2017. Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm584702.htm 803285960 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680

Journal

Reactions WeeklySpringer Journals

Published: Dec 2, 2017

There are no references for this article.

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 12 million articles from more than
10,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Unlimited reading

Read as many articles as you need. Full articles with original layout, charts and figures. Read online, from anywhere.

Stay up to date

Keep up with your field with Personalized Recommendations and Follow Journals to get automatic updates.

Organize your research

It’s easy to organize your research with our built-in tools.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve Freelancer

DeepDyve Pro

Price
FREE
$49/month

$360/year
Save searches from Google Scholar, PubMed
Create lists to organize your research
Export lists, citations
Read DeepDyve articles
Abstract access only
Unlimited access to over
18 million full-text articles
Print
20 pages/month
PDF Discount
20% off