FDA Expected To Comment On Its Safety Evaluation Of Nexium And Prilosec In December 2007
December 7th, 2007 Posted by: Dr. Cox
Agency’s Follow-Up On Its August 2007 “Early Communication” About These Heartburn Drugs Is Late, But Just In Time For Christmas Dinner
(Posted by Tom Lamb at DrugInjuryWatch.com)
As reported previously, in early August 2007 the FDA and Men’s health Canada raised concerns about possible serious cardiac events in patients using Nexium and Prilosec, made by AstraZeneca (AZN), which are used for the treatment of gastroesophageal reflux disease (GERD) and esophageal erosions, as well as for maintenance of healing erosions of the esophagus.
At that time the FDA had said it should have further guidance for doctors and patients concerning these two popular heartburn, or stomach-acid, drugs in approximately 90 days.
Now, almost four months after the FDA released this so-called “early communication” about Nexium (esomeprazole) and Prilosec (omeprazole), we finally get an indication that the FDA may be getting close to providing its more definitive advice on these two drugs, which are reportedly taken by more than one billion people worldwide.
As previewed by Reuters reporter Kim Dixon in her December 6, 2007 article, “FDA update on AstraZeneca heartburn drugs seen”, what the FDA will say about the safety of Nexium and Prilosec remains uncertain but, for sure, whatever is said by the FDA will be of great significance to AstraZeneca.