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FDA issued an Early Communication About An Ongoing Safety Review for Losec ,Prilosec (omeprazole) and Nexium (esomeprazole)



FDA issued in the united state an early communication about the ongoing review of new safety data for the proton pump inhibitors, Prilosec and Nexium. 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 gastroesophageal reflux disease (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, 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. Healthcare providers should not change their prescribing practices and patients should not change their use of these products at this time.

Both drugs are used for the treatment of GERD, esophageal erosions and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Prilosec is also sold over the counter for frequent heartburn.

The Saudi Food and Drug Authority recommends patients taking this product to continue their therapy until further more reliable evidence showing whether this product causes Heart problems or not.

Drugs registered in Saudi Arabia                    

Trade name                                 

 Generic name                         

          Aciloc ®












      ( (Omeprazole 10, 20, 40 mg CAPS

                  (Omeprazole 20 mg CAPS)

                 (Omeprazole 20 mg CAPS )

                 ( Omeprazole 20 mg CAPS)

                (Omeprazole 20 mg ECTAB)

                    (Omeprazole 20 mg TAB)

                (Omeprazole 10,20 mg TAB)

                (Omeprazole 10,20 mg TAB)

              (Omeprazole 20 mg EC TAB )

          (Omeprazole 40 mg/10 ml Vial )

               (Omeprazole 10,20 mg TAB)

 Trade name              

Generic name                 


esomeprazol 20,40 mg            

source : U.S. Food and Drug Administration
August 9, 2007