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Prevacid 24HR First OTC PPI With Skin Reaction Warning

 
• By Hannah Daniel

Lansoprazole along with other OTC and Rx PPI ingredients were linked to a potential risk of acute generalized exanthematous pustulosis FDA in 2019 found a trend in adverse event reports.

• Source: Shutterstock

A label warning required for OTC proton pump inhibitors in the US due to a potential risk of rare skin reaction was added first to Perrigo Company PLC’s Prevacid 24HR containing lansoprazole.

Lansoprazole and the two other PPI ingredients approved for OTC sales in the US, esomeprazole and omeprazole, along with several...

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More from Regulation

Portfolios In Large US Food Industry Merger Cleared By FTC Include Nutritional Supplements

 
• By Malcolm Spicer

FTC decision, says Bureau of Competition director Daniel Guarnera, influenced by both companies marketing different lines in different countries, limiting the number of similar products in the same categories the combined firm would offer.

EU Industry Wants EFSA Changes To Support Innovation

 
• By Tom Gallen

Prominent trade groups call on the European Commission to improve risk assessment of innovative food products by making changes to processes at the European Food Safety Authority.

US FDA Clarifies Success For An NDI Notification Fits Only The Notifier’s Ingredient

Along with two instructional videos, FDA provides fact sheet detailing common problems with NDINs while supplement industry awaits guidance on two hurdles for clearing the NDIN process, providing identity information and evidence of safety for ingredients.

AESGP Annual Meeting: Harmonizing EU VMS Max Levels Could Cost Sector Over €200m

 
• By David Ridley

Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.

More from Policy & Regulation

US FDA Clarifies Success For An NDI Notification Fits Only The Notifier’s Ingredient

Along with two instructional videos, FDA provides fact sheet detailing common problems with NDINs while supplement industry awaits guidance on two hurdles for clearing the NDIN process, providing identity information and evidence of safety for ingredients.

Price To Resolve US Hemp Dilemma Too High In House Appropriators’ FY 2026 FDA Spending Bill

 
• By Malcolm Spicer

Provisions in bill approved by Agriculture, Rural Development, FDA and Related Agencies Subcommittee aren’t likely to pass largely because they set a price too high for delta-8 THC and other ingredients to meet the definition of hemp as a de-scheduled substance.

AESGP Annual Meeting: Harmonizing EU VMS Max Levels Could Cost Sector Over €200m

 
• By David Ridley

Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.