U.S. eyes AstraZeneca stomach meds' hip risk
WASHINGTON (Reuters) - U.S. regulators said on Monday they had cleared AstraZeneca Plc's best-selling heartburn drugs Prilosec and Nexium of links to heart problems, but disclosed a review of a potential risk for hip fractures.
The Food and Drug Administration concluded the drugs' have no negative impact on the heart, an issue under scrutiny after two small studies suggested a greater risk of heart attacks, heart failure and heart-related sudden death from the drugs than from surgery to remedy severe reflux disease.
However, FDA officials revealed a separate agency examination of hip fracture risk potentially associated with the class of drugs to which Nexium and Prilosec belong, as they briefed reporters about the heart assessment.
Last December, the Journal of the American Medical Association reported on a study suggesting that long-term use of the drugs, called proton pump inhibitors, increases the risk of hip fractures in adults over 50.
"Internally we've looked at the issue and we've asked the sponsors to send additional information and analysis," Joyce Korvick, deputy director in the gastroenterology unit at FDA said in response to a question. "That is under review."
The potential mechanism for any increased risk is that the drugs, that reduce the amount of acid produced by the stomach, inhibit the absorption of calcium, researchers have said.
In addition to Nexium and Prilosec, other proton pump inhibitors include Wyeth's Protonix and Eisai Inc's Aciphex.
More than 1 billion people have taken Prilosec and Nexium, according to AstraZeneca. Both are sold by prescription to treat acid reflux and ulcers, while Procter & Gamble Co, sells Prilosec over-the-counter for frequent heartburn.
AstraZeneca spokesman Blair Hains said the company supplied the FDA with data on the fracture issue and said the drugs' long track record does not find a link.
HEART LINK REJECTED
The FDA, which regulates the world's biggest drug market, said its heart assessment was based in part on 14 studies of Prilosec, the older product. Four of those studies were placebo-controlled, the gold standard for clinical trials.
After evaluating two studies that triggered the heart review, the FDA discovered more patients getting the drugs had a history of heart attacks, skewing the initial signal of heart issues.
"Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses ... does not indicate the presence of a true effect," the FDA said.
In August the FDA issued an "early communication" about the heart issue, part of a new FDA effort to notify the public and doctors earlier when they detect potential drug risks.
The early notification practice comes after criticism of a slow response in dealing with now-recalled painkiller Vioxx, a Merck & Co drug, and safety fears tied to GlaxoSmithKline's diabetes drug Avandia.
"The FDA spent years not saying much about things they were looking into," said Ira Loss, an FDA watcher at Washington Analysis. "Now, the opposite is going on. They are going to tell everybody every time they are looking into anything and most of the time it is going to turn out to be nothing."
Nexium, a slightly altered form of Prilosec, is AstraZeneca's top-selling medicine, generating sales of $5.2 billion last year. It was also the world's second-best selling drug in 2006, according to pharmaceutical information firm IMS Health.
AstraZeneca agreed with the FDA's assessment of no risk of increased heart problems. Merck shares profits from the drugs.
On the New York Stock Exchange, AstraZeneca shares closed up 4 cents, to $47.04 on Monday.
(Reporting by Kim Dixon; Editing by Lisa Von Ahn and Tim Dobbyn)
