Please login to the form below

Not currently logged in
Email:
Password:

FDA releases safety review regarding Prilosec and Nexium

The FDA has issued an early communication about the ongoing review of new safety data for Prilosec and Nexium, which are prescribed in the US for the treatment of gastroesophageal reflux disease (GERD), esophageal erosions and ulcers

The FDA has issued an early communication about the ongoing review of new safety data for the proton pump inhibitors, Prilosec and Nexium, which are prescribed in the US for the treatment of gastroesophageal reflux disease (GERD), esophageal erosions and ulcers.

Prilosec is also sold OTC for frequent heartburn.

The new safety data was from two small long-term clinical studies in patients with severe GERD. In both studies, patients were randomly assigned to receive treatment with a drug (either omeprazole or esomeprazole) or to have surgery to control their (GERD).

The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery. 

After reviewing these and other data submitted by the company, the FDA's preliminary conclusion at this time, is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole.

The agency advises that healthcare providers should not change their prescribing practices, while patients should not change their use of these products at this time.

9th August 2007

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
EPG Health

REACH, ENGAGE & MEASURE - Accomplish meaningful HCP engagement via Medthority, our trusted independent medical website. Support education and treatment...

Latest intelligence

Has the pandemic opened up a future of accelerated diagnosis and better care for rare disease patients?
The challenge with rare disease is in the name – it's rare, so awareness is limited and diagnosis hindered. Could a more virtual existence change this? A Medical Affairs viewpoint...
The other side of … blood cancer
To stay motivated for the fight, some patients need to feel like active players in the treatment journey, not passengers to every decision....
COVID clinical trial
COVID-19 – a catalyst for technology adoption in clinical trials
As the COVID-19 crisis disrupts clinical trials around the globe, it is also proving to be a catalyst that may transform its approach to trials for good...

Infographics