Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Public Citizen Urges FDA To Add Sweeping Warnings To PPI Labels

This article was originally published in The Tan Sheet

Executive Summary

Public Citizen petitions FDA to add several warnings to all proton pump inhibitors, including OTCs – which the agency previously determined do not pose the same level of risk as prescription versions.

You may also be interested in...



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.

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.

UK Notes PPI Dermatosis Risk: Will FDA Make Similar Communication?

The UK drug regulator announces “a very low risk” of sub-acute cutaneous lupus erythematosus from use of PPIs, which are available there with the same ingredients approved for use in the US in products available OTC and RX – esomeprazole, lansoprazole and omeprazole – and Rx only, pantoprazole and rabeprazole.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS105269

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel