FDA Look at Nexium Safety Spooks Investors
Wall Street Journal
Posted By Jacob Goldstein On 9th August 2007
The FDA said this morning that it’s looking at the safety of AstraZeneca’s heartburn drug Nexium and its kissing cousing Prilosec. The regulators said in pretty clear terms that the review isn’t likely to amount to much, but that wasn’t enough to calm investors made skittish by the FDA’s tougher stance on drug safety.
AstraZeneca stock fell more than 5% this morning before starting to recover.
The review was prompted by two studies (one of each drug) that suggested patients who took the pills were more likely to have heart attacks, heart failure and heart-related sudden death than similar patients who underwent surgery for severe reflux disease, the FDA said in a statement.
But further analysis of the data showed that those who had surgery may have been less likely to have heart trouble to begin with. Studies that compared Nexium against placebo didn’t suggest that the drug increased the risk of heart trouble, the agency said. Overall, the “data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole,” the generic names for Nexium and Prilosec, the FDA wrote.
Still, the fact that the drugs probably don’t cause serious heart trouble is unlikely to stop the howls from insurers and a cadre of academic doctors. They argue that heavy marketing has caused the drugs to be prescribed too often and for too long, at the expense of lifestyle changes or cheaper generics that would work as well or better for many patients.
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