Petition Seeks OTC PPI Warning On Cancer Risk From Persistent Heartburn

OTC proton pump inhibitors should carry a warning that the products do not eliminate risks of esophageal cancer from persistent heartburn, says the Esophageal Cancer Action Network in a citizen petition to US FDA. FDA should “immediately” require the warning, which should be bold and prominent.

FDA is being asked to add yet another safety warning to OTC proton pump inhibitors. A citizen petition requests requiring a label warning on the risk of esophageal cancer from persistent heartburn, a risk not lessened by PPI use.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Drug Safety

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 

Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

More from Pink Sheet

ICH Modernizes Stability Testing Guideline

 
• By 

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 

US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease