FDA eyes Nexium, Prilosec for heart risks with early communication
The Food and Drug Administration flagged potential cardiovascular risks with AstraZeneca's Nexium and its predecessor, Prilosec, but said it has not yet established an increased risk and discouraged doctors and patients from discontinuing use of the drugs.
The agency issued an “early communication” on the matter, saying its reviewers are in the midst of combing through safety data from two small long-term clinical studies in patients with severe GERD using the drugs. The results of the study “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,” said the FDA statement. However, the agency said: “FDA's preliminary conclusion….is that collectively, these data do not suggest an increased risk of heart problems for patients” and that healthcare providers should not change their prescribing practices, nor should patients discontinue treatment.
FDA officials said they expect to complete their review of the data within three months, at which time they will make their conclusions public, but declined to discuss specifics of the data or the clinical trials.
Prilosec lost patent protection in 2002, but Prilosec OTC, marketed by P&G, was introduced in 2003. Nexium, AstraZeneca's follow-on to the original Purple Pill, has been more heavily promoted to consumers than any other drug. AstraZeneca spent $1.08 billion on DTC for the drug between 2002 and 2006, spending $181 million on Nexium consumer ads last year alone, according to TNS Media Intelligence.