by Kim Dixon
Last Updated: 2007-12-10 16:01:50 -0400 (Reuters Health)
WASHINGTON (Reuters) – U.S. regulators said on Monday they had cleared AstraZeneca Plc’s Prilosec and Nexium of links to heart problems, but disclosed a review of a potential risk for hip fractures with use of proton pump inhibitors.
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 MI, heart failure and sudden cardiac death from the drugs than from surgery for severe reflux disease.
However, FDA officials revealed a separate agency examination of hip fracture risk potentially associated with the class of proton pump inhibitor drugs, 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 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."
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 CLEARED
The FDA said its heart assessment was based in part on 14 studies of Prilosec, the older product. Four of those studies were placebo-controlled.
"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.
