This Monday, The Food and Drug Administration said that AstraZeneca PLC’s reflux drugs Nexium and Prilosec don’t present an increase risk in heart attacks and sudden death.
The agency it reviewed two-long term studies submitted in May by AstraZeneca and other 14 additional studies. The agency concluded that the products weren’t likely “to be associated with an increased risk of heart problems."
The small long-term studies were submitted by AstraZeneca when FDA was conducting this year a safety review of the drugs approved to treat gastroesophageal reflux disease. The submitted studies suggested that the drugs could increase heart risk and cause sudden death. The studies were about assessing the effectiveness of the two drugs in comparison with surgery for severe GERD. The cardiovascular events that have appeared during the medicines’ trials made FDA to ask for more studies in order to evaluate whether long-term use of the drugs increases heart risk.
After its review on Prilosec and Nexium the FDA couldn’t find the presence of a true effect of these drugs in increasing heart risk and sudden death. The FDA recommended that the drugs should be prescribed by health care providers and used by patients as described in their labeling.
The two drugs are part of the class called PPI, meaning proton pump inhibitors. They decrease the amount of acid produced in the stomach in order to help healing erosions in the lining of esophagus. They are also used with an antibiotic when treating gastric ulcer. Prilosec is also sold over the counter and prescribed for heartburn.