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Petition Seeks OTC PPI Warning On Cancer Risk From Persistent Heartburn

 
• By Eileen Francis

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.

“The warnings on current products are not sufficient to alert patients to the risk of esophageal cancer associated with persistent...

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Mifepristone: Judge Orders US FDA To Rethink Need For REMS Restrictions

 
• By Sue Sutter

A federal judge in Hawaii ruled the FDA failed to consider statutory factors relevant to the REMS and provide a “reasoned explanation” for its restrictive treatment of the drug, but remand could result in an agency determination that more extensive restrictions are needed.

UK MHRA’s AI Push Targets Predicting Harmful Drug Mixes And Helping Make Licensing Decisions

 
• By Anabel Costa-Ferreira

A new government-backed initiative is set to explore the use of AI in predicting side effects from drug interactions – a development that could cut costs and late-stage trial failures for pharma companies.

EMA Intensifies Push To Cut Non-Human Primate Use In Drug Trials

 
• By Eliza Slawther

Pharma companies are being asked for their views on a scientific reflection paper from the European Medicines Agency that discusses alternatives to using non-human primates in drug safety studies.

US FDA Plans Move Back To More Generalist Inspectorate

 
• By Sarah Karlin-Smith and Derrick Gingery

The “Simple Reform” initiative would reverse a 2017 move to ensure FDA investigators were experts in the commodity they inspected or in clinical research regulations.

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NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.