Dec. 10, 2007 — The FDA today affirmed that it sees no likely interface between heart attacks or other heart risks and the long-term use of Prilosec and Nexium, which are drugs that treat gastroesophageal reflux disease (GERD).
“We have completed our safety audit … and it is our assessment that the considers don’t appear a hazard for heart assault or heart-related issues,” Paul Seligman, MD, said in a press conference. Seligman is the associate executive for security arrangement and communication at the FDA’s Center for Medicate Evaluation and Investigate.
Today’s FDA announcement asserts the FDA’s introductory review of security information for Nexium and Prilosec. That audit, discharged in Eminent, showed no signs of heart dangers related with long-term use of Nexium or Prilosec.
The FDA began its audit in May, when AstraZeneca, the drug company that makes Nexium and Prilosec, sent the FDA data from two long-term studies of GERD patients taking Nexium or Prilosec.
Those studies raised questions approximately whether long-term utilize of the drugs increments the hazard of heart assaults, heart disappointment, and heart-related sudden death in patients taking either one of the prescribed drugs compared with patients who got surgical treatment.
The FDA analyzed information from those considers, along with data from additional considers, before issuing today’s administering.
The FDA recommends that “wellbeing care providers continue to prescribe, and patients continue to utilize, these products as described in the labeling for the two drugs,” the FDA states in a news discharge.
Seligman says the FDA hasn’t asked any follow-up trials on the issue.