We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Says Prilosec and Nexium Not a Heart Risk

FDA Says Prilosec and Nexium Not a Heart Risk

December 17, 2007

The FDA has confirmed an earlier assessment that there is no evidence of an increased risk of heart attacks or other heart problems with AstraZeneca’s gastrointestinal drugs Prilosec and Nexium.

The agency issued a MedWatch alert in August, saying that the drugs did not appear to increase the risk of serious cardiovascular adverse events, but it was still considering whether to take any regulatory action on the products.

The FDA’s August MedWatch statement will be archived on the agency’s website, and a notice appended that there is an update on the subject, but it will not be removed, Paul Seligman, CDER’s associate director for safety policy and communication, said. In that statement, the agency said concerns began when a 14-year randomized study found that patients taking Prilosec (omeprazole) to treat gastroesophageal reflux disease experienced more heart attacks, heart failure and heart-related sudden death than patients who received surgery.

The agency has completed its comprehensive scientific review of known safety data for Prilosec and Nexium (esomeprazole magnesium). It received safety data from two small long-term studies of both drugs May 29, but as the study protocols did not specify how heart problems like heart attacks were defined or verified, evaluating the safety information was challenging, the agency said.

The agency added that its assessment of the safety data gathered was further supported by an analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with either drug, the agency concluded.

    Upcoming Events

    • 28Sep

      The Cost of Counterfeiting: Why You Need a Plan to Secure Your Medical Device Supply Chain

    • 28Sep

      Calculating Sample Size to Satisfy FDA Expectations

    • 11Oct

      GMP Quality Management vSummit 2023: Where Quality Meets Risk

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    • 08Nov

      18th Annual FDA Inspections vSummit

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • Manufacturing Cost is Key Issue Facing Gene Therapy Products, Marks Says

    • Artificial Womb Technology Not Yet Ready for Human Trials Adcomm Says

    • Top Concern for CBER is Marketing of Unapproved Biologics, Says FDA Official

    • FDA Deems Medline Industries’ Saline Solution Vial Recall as Class 1

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing