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Public Citizen Seeks Black Box Warnings on Acid Reflux Drugs

The Los Angeles Times reported in its “Booster Shots” blog, “The watchdog group Public Citizen on Tuesday asked the US Food and Drug Administration to warn Americans that” proton-pump inhibitors, intended to combat acid reflux and heartburn, under the brands Nexium, Prilosec, Zegerid and Prevacid, “can be habit-forming and carry a wide range of other dangers” including: “rebound acid hypersecretion;” “severe magnesium deficiencies;” “fractures of the hip, wrist and spine;” reduced “effectiveness of some heart drugs when they are taken together;” possible “interference with cancer chemotherapies;” and “higher rates of recurrent C difficile infection, causing severe diarrhea.” Public Citizen is requesting that the FDA “add black box warnings and other safety information to the packaging of these medications.”

MedPage Today reports, “Public Citizen filed a petition with the FDA formally requesting warnings…in the form of updated labels, patient medication guides, and ‘Dear Doctor’ letters.” It also “charged that many patients are taking PPIs without a clear need for them.” Many of the side effects “are already described in the current product labels, but Public Citizen said they should receive ‘the strongest possible warning.’”

ABC reported, “Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said he hopes stricter warnings will curb unnecessary use of the drugs.” Wolfe noted that while a number of risks are on the label, the risk of dependence “is not.” Dr. Jacqueline Wolf, associate professor of medicine at Harvard Medical School, said, “It’s absolutely true that too many people are on these medications.”

From the American Association for Justice news release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

About This Blog

The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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