FDA officials say it will need three months to thoroughly analyze data on possible cardiac risk associated with Nexium and Prilosec, both proton pump inhibitors used to treat heartburn and reflux disease. Regulators and the drugs' maker, AstraZeneca, are telling patients and doctors to take and prescribe as usual in the meantime. The FDA also is asking for safety data from makers of other proton pump inhibitors.
The data in question arose from a 14-year study of reflux disease treatment. The increased risk of heart attack, heart failure, and sudden death from cardiac events in patients taking Prilosec began before the study was a year old, the FDA says, and continued throughout. With Nexium, the risk began early but seemed to dissipate as the study wore on. The FDA is questioning the study's design, however, and cites data from other trials showing no increase in cardiac problems.
The agency's preliminary assessment: no increased risk from either drug. But we've heard that tune before, most recently with Avandia. This time, at least, the FDA is coming clean about the possible safety problems only a couple of months after receiving the data--instead of more than a year. The whole mess is enough to give the average consumer...well, heartburn.
- read the report from Forbes
- see this New York Times article