FDA: Nexium, Prilosec OK for Heart

FDA Finds No Link Between Heart Risks and Long-Term Use of Nexium or Prilosec

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

Dec. 10, 2007 -- The FDA today confirmed that it sees no likely link 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 review ... and it is our assessment that the studies do not show a risk for heart attack or heart-related problems," Paul Seligman, MD, said in a press conference. Seligman is the associate director for safety policy and communication at the FDA's Center for Drug Evaluation and Research.

Today's FDA announcement affirms the FDA's initial review of safety data for Nexium and Prilosec. That review, released in August, showed no signs of heart risks associated with long-term use of Nexium or Prilosec.

The FDA began its review 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 about whether long-term use of the drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared with patients who got surgical treatment.

The FDA analyzed data from those studies, along with data from additional studies, before issuing today's ruling.

The 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," the FDA states in a news release.

Seligman says the FDA hasn't requested any follow-up trials on the issue.

SOURCES: News release, FDA. WebMD Health News: "Nexium, Prilosec: No Heart Risks Seen." Paul Seligman, MD, associate director, Safety Policy and Communication, Center for Drug Evaluation and Research, FDA.

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