Prilosec and Nexium heart risk reviewed by FDA
Prilosec and Nexium, two popular heartburn drugs, are being reviewed by the FDA due to concerns that they may increase the risk of heart problems. Although data submitted to federal regulators from two long-term studies indicate users suffered more heart related injuries, a preliminary analysis by the FDA suggests that there is no firm evidence of a Prilosec of Nexium heart risk. The final FDA review should be completed in about three months.
Prilosec (omeprazole) and Nexium (esomeprazole), are medications used for treatment of gastresphageal reflux disease (GERD), ulcers and frequent heartburn. Both drugs are manufactured by Astra Zeneca PLC, and are part of a class of drugs known as proton pump inhibitors (PPIs). Nexium is sold only by prescription from a physician, but Prilosec is available over the counter from Proctor & Gamble, Co.
The two clinical studies which raised concerns about Prilosec and Nexium heart risks compared groups of individuals who treated with one of the two drugs to those who underwent surgery for treatment of GERD. The data indicated that long-term use of the heart burn drugs could increase the risk of heart attacks, heart failure and heart-related death.
The FDA was originally provided the data in May, and they have since reviewed follow up information on the two studies, as well as performed additional analysis of other controlled studies. Yesterday, the federal regulators reached a preliminary conclusion that the data does not suggest that Prilosec or Nexium increase the risk of heart problems. They are continuing to review the safety of the drugs, but released an “early communication” about their on-going safety review on their website.
>>FDA STATEMENT: Prilosec and Nexium Heart Risks
Based on the analysis done so far, the FDA indicates that they are not convinced Prilosec and Nexium are linked to an increased risk of heart attacks, heart failure or heart related death. Regulators pointed to other influences which could explain the increased number of heart problems. They stated that the results could be due to chance, since many of the individuals assigned to the surgery group withdrew before they ever underwent the procedure and those who were assigned to the surgery group tended to be younger and less likely to have risk factors for heart problems.
Pending the final review of Prilosec and Nexium, the federal health officials have recommended that doctors not change their prescription practices, and patients should not discontinue use of these products based on the information available at this time. If you, a friend or family member are concerned about Nexium or Prilosec heart risks, consult with your physician.
The FDA has been under fire lately after delaying the public release of information regarding Avandia heart risks. After data submitted by the manufacturers of Avandia indicated that the diabetes drug increases the risk of heart attacks, the FDA did not warn consumers, despite internal debate over whether there should be an Avandia recall. It appears that the federal agency is taking a more open approach with this data, informing the public of the preliminary findings even before the analysis is complete.
UPDATE 12/10/2007: FDA’s Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events
FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium. While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified. As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging. FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.
Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect. Therefore, FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.
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