No cardiovascular risk found in Prilosec/ Nexium says FDA

The FDA's review of clinical studies involving AstraZeneca's antacid drugs Nexium and Prilosec does not demonstrate an increase in heart attacks and sudden death

The FDA's review of clinical studies involving UK-headquartered AstraZeneca's (AZ) antacid drug Nexium (esomeprazole) and Prilosec (omeprazole) has not demonstrated an increase in heart attacks and sudden death.

Since May 2007, the FDA has been conducting a safety review of the drugs, which are approved to treat gastroesophageal reflux disease, when AZ submitted the results of two small, long-term studies that suggested the drug could increase the risk of heart problems and sudden death. Prilosec is also marketed in OTC versions in the US.

The FDA asked AZ to submit extra data about the drugs for review. The agency said its review of the two long-term studies, along with 14 additional studies, shows the products are "not likely to be associated with an increased risk of heart problems".

11th December 2007

PME Digital Edition

Featured jobs

Director – Healthcare PR: Salary TBC

Client Partnership Director – Top Med Comms Agency: Salary TBC

Product Manager - Hertfordshire: Competitive salary depending on experience benefits

Medical Writer - Medical Communications: £30, 000 - £40, 000 according to skills and experience plus benefits

Senior Account Manager / Account Director: Great salary and bebefits

CALLING ALL SENIOR HEALTHCARE PR FREELANCERS!!!!! ACCOUNT DIRECT...: EXCELLENT DAY RATES AVAILABLE

Medical Writer - (London, Brighton or Copenhagen): Competitive

Senior Account Director or Business Unit Director, Healthcare Ad...: C£60, 000 – £70, 000 benefits

Group Account Director – Medical Communications – Manchester: Salary TBC

Editorial Team Leader or Scientific Director: £50, 000 - £55, 000 benefits

PRINCIPAL MEDICAL WRITER or ETL - OPTIONAL HOME WORKING - MEDICA...: Salary TBC

Assistant Product Manager - Hertfordshire: Competitive salary depending on experience benefits

Sales & Marketing Manager - New Launch - Mental Health - S E...: Highly Competitive Basic, Bonus &Benefits

Associate Director, Healthcare PR: £60, 000 – £67, 000+ benefits

Senior Medical Writer: Great salary and bebefits

Account Manager, Healthcare PR: £40, 000 – £42, 000 great benefits and bonuses

Scientific Director: Great salary and bebefits

Account Director – Healthcare PR – Exciting Client Mix: Salary TBC

Junior Account Director – Medical Comms – Kent: Salary TBC

Editorial Director – Medical Communications – London + 3 Days ho...: Salary TBC

NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE: NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE The bold digital clock featured on the EUGDPR (EU General Data Protection Regulation)1 website indicates – to the second...
Health knowledge: Why is it so important?: Health knowledge plays an important role in population health, but by itself is rarely enough to prompt a change in the behaviours that cause the risks....
Personas: a top tool for personalising pharma marketing campaigns: Healthcare customers are calling for greater personalisation in care from providers. Here, we explain why personas are the top tool for ensuring your brand meets this need efficiently and effectively....