US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

      Summary Company Announcement Date: June 27, 2025 FDA Publish Date: June … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Safety News / Drug Used to Treat Gout Is Dangerous, FDA Warns

Drug Used to Treat Gout Is Dangerous, FDA Warns

April 23, 2019 By Lynn Fugaro Leave a Comment

Gout

On February 21, 2019, the Food and Drug Administration (FDA) posted the following urgent message on its website: “The FDA has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.”

As a result of the findings showing dangers associated with Uloric, the FDA also updated the prescribing information for this gout medication to require what’s called a “Boxed Warning,” which is the FDA’s most prominent warning. Boxed warnings are colloquially referred to as “black box warnings.” The FDA also ordered that the drug febuxostat, which is the generic name for Uloric, be used only in those patients who do not respond to allopurinol, or who experience adverse side effects when taking allopurinol. Allopurinol has been used for decades, is safe, and effective according to the FDA.

What is Uloric; What is Gout?

Approved by the FDA in 2009, Uloric is manufactured by Takeda Pharmaceuticals, one of largest pharmaceutical companies in the world and the largest drug maker in Asia. Since 2012, the company has reported earnings over $16.2 billion in revenue; Takeda Pharmaceuticals mainly produces drugs that treat metabolic disorders, gastroenterological issues, neurological issues, inflammation, and cancers.

Febuxostat works by stopping the body from turning naturally occurring purines or those that come from food and drink into uric acid. About two-thirds of the uric acid in the body is produced naturally; the rest comes from your diet, often in the form of purines, which are substances in animal and plant food that the human body converts to uric acid. Too much uric acid in the body causes gout, according to Arthritis.org.

If your kidneys cannot flush uric acid from the system, it can build up in the bloodstream and be deposited as needle-shaped crystals in your joints. These crystals cause the severe inflammation and intense pain of a gout attack. MayoClinic.org explains gout as a “common and complex form of arthritis that can affect anyone.”

Gout is characterized by sudden, severe attacks of pain, swelling, redness and tenderness in the joints, often the joint at the base of the big toe. “An attack of gout can occur suddenly, often waking you up in the middle of the night with the sensation that your big toe is on fire. The affected joint is hot, swollen, and so tender that even the weight of the sheet on it may seem intolerable.”

Dangerous Drug

The FDA says there’s an increased risk of death associated with Uloric when compared to another popular gout medicine, allopurinol. Uloric has shown an increased risk of heart-related death, as well as death from other causes associated with the drug. One study showed that in patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for one year. Additionally, there were 26 deaths from “any cause per 1,000 patients treated for one year with this dangerous drug.”

If you’re currently taking Uloric, please contact your doctor to find out if at risk. No drug should be stopped suddenly without first consulting the prescribing physician. Patients with the following symptoms should contact their doctor immediately:

  • Chest pain
  • Difficulty breathing
  • Rapid or irregular heart rate
  • Numbness or weakness affecting one side of the
  • Dizziness, vertigo, or trouble standing
  • Difficulty speaking (forming sentences)
  • Severe headache that comes on quickly

Patients taking Uloric may face an increased risk of:

  • Cardiac event-related death
  • Non-deadly heart attack
  • Non-deadly stroke
  • Unstable angina
  • Death

If you’ve lost a loved one who was taking Uloric, please contact a defective drug injury attorney in your area.

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: Safety News, Uloric

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting
Accident Attorneys

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

June 27, 2025 By The FDA

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

DR Power Recalls Lithium-Ion Battery Packs Due to Fire and Burn Hazards

June 25, 2025 By The CPSC

Total Saddle Fit Recalls Western Saddle Cinches Due to Fall and Injury Hazards

June 25, 2025 By The CPSC

Professional’s Choice Sports Medicine Products Recalls Equine Bits Due to Fall Hazard

June 25, 2025 By The CPSC

LED Fireplace Lanterns Recalled Due to Risk of Serious Injury or Death from Ingestion Hazard; Violations of Federal Standard for Consumer Products with Coin Batteries; Imported by Green Pastures Wholesale

June 25, 2025 By The CPSC

Bell Sports Recalls Bicycle Helmets Due to Risk of Head Injury; Violation of Federal Standard for Bicycle Helmets

June 25, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

LED Fireplace Lanterns Recalled Due to Risk of Serious Injury or Death from Ingestion Hazard; Violations of Federal Standard for Consumer Products with Coin Batteries; Imported by Green Pastures Wholesale

June 25, 2025 By The CPSC

Bell Sports Recalls Bicycle Helmets Due to Risk of Head Injury; Violation of Federal Standard for Bicycle Helmets

June 25, 2025 By The CPSC

Sanven Technology Recalls Vevor Handrails Due to Injury Hazard

June 25, 2025 By The CPSC

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
  • Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
  • The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands
  • iHerb Recalls Bottles and Blister Packs of California Gold Nutrition Iron Supplements Due to Risk of Serious Injury or Death from Child Poisoning; Violation of Federal Standard for Child Resistant Packaging
  • Peg Perego Recalls Tatamia 3-in-1 Recliners, Swings and High Chairs Due to Risk of Suffocation; Violations of Multiple Federal Standards (Recall Alert)
  • DR Power Recalls Lithium-Ion Battery Packs Due to Fire and Burn Hazards
  • Total Saddle Fit Recalls Western Saddle Cinches Due to Fall and Injury Hazards
  • Professional’s Choice Sports Medicine Products Recalls Equine Bits Due to Fall Hazard
  • LED Fireplace Lanterns Recalled Due to Risk of Serious Injury or Death from Ingestion Hazard; Violations of Federal Standard for Consumer Products with Coin Batteries; Imported by Green Pastures Wholesale
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2025 Altrumedia · Terms of Service · Log in