La FDA ha concluído que el uso a largo plazo de los inhibidores de la bomba de protones (IBP) omeprazol y esomeprazol no está asociado con un riesgo incrementado de problemas cardiacos.En Agosto, la FDA había publicado un reporte preliminar que al parecer estas drogas no incrementaban el riesgo cardiaco. Ahora, después de finalizar su revisión de la evidencia, la agencia a reafirmado su postura.
FDA informed healthcare professionals of the issuance of the Agency’s follow-up communication regarding its review of safety data for the drugs omeprazole and esomeprazole that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. See the “Update of Safety Review” for information regarding the two studies that were reviewed.
Read the complete MedWatch 2007 Safety Summary including a link to the follow-up FDA communication regarding this issue at: