Ongoing Review of Safety Data for Prilosec and Nexium

FDA is continuing to review new safety data for the proton pump inhibitors Prilosec (omeprazole) and Nexium (esomeprazole), which are used to treat severe gastroesophageal reflux disease (GERD).

These data came from two small long-term clinical studies where patients with severe GERD were assigned to be treated with Prilosec or Nexium or to receive surgery. The results 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 patients on drug therapy compared to those who received surgery.

After reviewing these studies, along with other information submitted by the company, FDA's preliminary conclusion is that taken together, these data do not suggest an increased risk of heart problems for patients treated with Prilosec or Nexium. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.

FDA Patient Safety News: October 2007

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=68#4

Category:

News & Politics

Tags:

• GERD
• omeprazole
• esomeprazole

[nicholasyoder]

I've taken Prescription omeprazole for 7 years and now I have Liver damage. I have to have blood tests done all the time now. My liver enzymes are extremely high. No heartburn though. And no I've never been a drinker or abused drugs. Omeprazole messed up my liver, but what choice do I have but to take it? I used to go through a large bottle of Rolaids a month before I started omeprazole. Which is worse Rolaids or omeprazole?

[paleo99]

I would be more concerned with the obvious side effects like nutritional deficiencies--Calcium, Vit B12, etc. They're good drugs if taken short term or intermittently but I wouldn't want to take them for years consecutively.

[vampirehunter33]

@GarbageState no. I stated if your taking for example prilosec for an acid related condition and your taking 20mg and it's doing no good you could try upping the dosage . if upping it still does not fix the condition then you may be in need of surgery

[GarbageState]

@vampirehunter33 so if 20mg nexium or 20.6? prilosec otc helps with symptoms one should still take 40mg because doctors recommend?

[socalkev]

dudes ignore those people you can take nexuim and zantacs like me and my friend are cause we had/have severe gastritis with coughing so they gave him nexuim with zantacs and me prilosec with zantacs we take them same days but hours apart to avioid interfeerence or collision of the drugs :)

[vampirehunter33]

a recent clinical study showed 120 mg a day of omeprazole i.e. prilosec given to 50 individuals for a period of 4 years showed no side affects at all such as heart attacks etc ......

most people with GERD or extreme acid problems are not being told the truth. that they need to be taking 40 - 60 mg omeprazole a day which is 2 - 3 prilosec per day . This is what medical doctors recommend for gerd and esophagitis when acid swells the throat shut

[Diaz26IV]

wow!! that was informative. Thank you for being on our side!! i will not change anything with my medication or diet, cause in the end, my doctor is right!

[GarbageState]

uhhmm... can you trust FDA?

[GarbageState]

also don't forget liver metabolizes medication. it's best to avoid this crap. ppi can stop acid but it won't stop other stomach fluids from getting into the esophagus.

[ronv11]

some people are the people who get side effects. Most people do not get side effects but some do. becareful