Monday, July 6, 2015

FDA warns of increased fracture risk from heartburn drugs

The Food and Drug Administration warned consumers, doctors and other health professionals this week that certain antacid drugs called proton pump inhibitors (PPIs) increase the risk of wrist, spine and hip fractures. The medications available over-the-counter (Prilosec, Zegerid, and Prevacid) and by prescription (Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo) are among the most commonly prescribed drugs in America. FDA

FDA warns of increased fracture risk from heartburn drugs

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The Food and Drug Administration warned consumers, doctors and other health professionals this week that certain antacid drugs called proton pump inhibitors (PPIs) increase the risk of wrist, spine and hip fractures. The medications available over-the-counter (Prilosec, Zegerid, and Prevacid) and by prescription (Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo) are among the most commonly prescribed drugs in America.

According to IMS Health, a company with offices in Plymouth Meeting, Pa. that tracks drug sales, nearly 120 million prescriptions filled in 2009 at a cost of $13.6 billion for PPIs. Nexium, made by drug giant AstraZeneca with its U.S. headquarters in Wilmington, Del., generated nearly half the sales, producing revenues of $6.3 billion.

The FDA warning comes after a series five studies (1, 2, 3, 4, and 5) and an editorial published in the Archives of Internal Medicine on May 10 found that the medications increased the risk of a variety of problems including certain infections. One of those studies linked the drugs to increased risk of fractures in older women.

And in April another study in the same medical journal said the common combination of PPIs with the blood thinner Plavix decreased the effectiveness of that drug and resulted in increasing the number of heart patients who were readmitted to a hospital following an initial hospitalization for cardiac care.

Click here for the complete FDA drug safety communication.

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Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
Hooman Noorchashm, M.D., Ph.D. Cardiothoracic surgeon in the Philadelphia area
Amy J. Reed, M.D., Ph.D. Anesthesiologist and Surgical Intensivist in the Philadelphia Area
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