Reflux drugs studied for possible heart effects

The Baltimore Sun

WASHINGTON -- The government is investigating whether popular acid reflux drugs Nexium and Prilosec cause heart problems, federal health officials said yesterday.

An initial analysis indicates that the drugs don't increase the risk for heart attack or other heart problems, and the millions of patients taking the medicines or doctors prescribing them should continue, Food and Drug Administration officials said.

AstraZeneca, the British maker of the two drugs, alerted the FDA of possible side effects May 29 after making a preliminary review of data from two long-term studies comparing the drugs' effectiveness to surgery.

The FDA is reviewing more complete data from the two studies, as well as from 14 other studies of Prilosec. Officials expect to finish their investigation in three months.

Doctors prescribe Prilosec and Nexium for acid reflux and ulcers. Prilosec is also sold over the counter to treat frequent heartburn. Sales of Nexium totaled $6.7 billion last year, second in the world after the cholesterol-lowering drug Lipitor, according to IMS Health.

FDA officials, who have been criticized recently for waiting to disclose safety concerns about diabetes medication Avandia, said yesterday's announcement was the earliest the agency had made about a drug's possible risks. Officials said the FDA is trying to issue warnings more promptly.

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