The Rheumatologist
COVID-19 News
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Ankylosing Spondylitis Resource Center
    • Gout Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Systemic Lupus Erythematosus Resource Center
      • Rheumatoid Arthritis Resource Center
      • Gout Resource Center
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / FDA Issues Stronger NSAIDs Warning

FDA Issues Stronger NSAIDs Warning

July 29, 2015 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

GENERIC_Drugs_500x270The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal antiinflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and stroke on their labels.

You Might Also Like
  • FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning
  • FDA Strengthens Warning Label for Certain Antiinflammatory Drugs
  • FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare
Also By This Author
  • FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning

The FDA, the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that prescription NSAID labels be updated to include the following information:

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE
  • MI or stroke can arise when first beginning an NSAID, and the risk may increase with longer use.
  • MI or stroke risk appears to be higher with higher NSAID doses.
  • Initially it was felt that all NSAIDs had a similar risk, but new information makes it less clear that these risks are similar for all NSAIDs. The new data cannot determine if any particular NSAID is riskier than any other one.
  • Patients with or without heart disease or heart disease risk factors are at an increased risk of NSAID-related MI or stroke.
  • Generally, patients with heart disease or heart disease risk factors have a greater chance of developing an MI or a stroke following use of NSAIDs than those that do not. This is due to a higher baseline risk.
  • Patients who receive NSAIDs after a first MI were more likely to die in the first year following the MI vs. patients who did not receive NSAIDs following their first MI.
  • Using NSAIDs increases the risk of developing heart failure.

Drug Facts labels of OTC non-aspirin NSAIDs will also be updated with MI and stroke information.

Prescribers and patients should be on the alert for cardiac-related side effects while using NSAIDs. Any side effects with NSAIDs should be reported to the FDA’s MedWatch Program. Patients taking NSAIDs should be advised to get medical attention immediately if they experience such symptoms as chest pain, shortness of breath, trouble breathing, weakness in one part or side of their body, or slurred speech.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

  1. U.S. Food and Drug Administration. Safety Alerts: Non-aspirin nonsteroidal antiinflammatory Drugs (NSAIDs): Drug Safety Communication—FDA strengthens warning of increased chance of heart attack or stroke. 2015 July 9.

Filed Under: Analgesics, Drug Updates, Safety Tagged With: Drug Safety, FDA, Myocardial infarction, nonsteroidal antiinflammatory drug (NSAID), NSAIDs, stroke

You Might Also Like:
  • FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning
  • FDA Strengthens Warning Label for Certain Antiinflammatory Drugs
  • FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare
  • FDA Issues Safety Warning

ACR Convergence

Don’t miss rheumatology’s premier scientific meeting for anyone involved in research or the delivery of rheumatologic care or services.

Visit the ACR Convergence site »

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2021 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.