FDA: Some heartburn meds pose long-term fracture risk
December 31st, 2016
Some heartburn medications could increase the risk of hip, wrist and spine fractures in high doses or with long-term use, the Food and Drug Administration warned.
Such so-called proton pump inhibitors are used for the treatment of gastroesophageal reflux disease, stomach and small intestine ulcers and inflammation of the esophagus, along with frequent heartburn.
They include esomeprazole, sold under the brand name Nexium, dexlansoprazole (Dexilant). lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix) and rabeprazole (Aciphex). Over-the-counter versions include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).
The product labeling will be changed to describe the possible increased risk, the FDA said in a statement Tuesday.
"Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump inhibitors for one year or longer, or at high doses," said Dr. Joyce Korvick, deputy director for safety in FDA's Division of Gastroenterology Products.
"Because these products are used by a great number of people, it's important for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition."
The warning and revised labeling stems from the FDA's review of several studies that reported an increased risk of hip, wrist and spine fractures in people using proton pump inhibitors. The warnings and precaution sections of prescription labels and the drug facts label on over-the-counter medications will address the findings, the agency said.
About HKQ Law
HKQ Law is considered one of the top civil litigation and commercial law firms in Northeastern Pennsylvania. Nine attorneys at HKQ Law were recently named to the 2019 Best Lawyers List and has been designated a Tier 1 Best Law Firm for personal injury, medical malpractice litigation labor law and corporate law in Northeastern Pennsylvania and the Lehigh Valley. The firm’s Personal Injury Team, led by Attorney Joe Quinn, has won some of the largest verdicts and settlements in the region's history on behalf of injured clients. The firm was also recently recognized for one of the top 20 Verdicts in Pennsylvania.
The Personal Injury Team focuses on a wide array of personal injury claims and civil litigation, including medical malpractice, auto and truck accidents, aviation accidents, unsafe vehicles, dangerous or defective products, workplace injuries (worker's compensation), construction site accidents, claim denials by insurance companies, dangerous drugs, defective children's products, nursing home abuse and neglect, and falls due to unsafe conditions (slip and fall).
Attorney Joseph A. Quinn is one of only 100 attorneys in the United States (and one of only three in Pennsylvania) honored with membership in the Inner Circle of Trial Advocates, and one of only 500 attorneys worldwide chosen to be a Fellow of the International Academy of Trial Lawyers. He has been a Pennsylvania Super Lawyer every year since the program began and has been listed in The Best Lawyers in America every year since the publication was established in 1987. Best Lawyers also named him top personal injury attorney for Northeastern Pennsylvania and the Lehigh Valley.
Since the inception of the firm, the Commercial / Corporate Team led by Attorney Allan Kluger has provided comprehensive, integrated legal services to many of Northeastern and Eastern Pennsylvania's largest corporations, businesses, banks, non-profits and institutions, handling matters involving labor and employment, wills, trusts and estate planning, estate administration, elder law, commercial transactions, residential and commercial real estate, zoning, land use and development, telecommunications, mediations and arbitrations, commercial litigation, title insurance, business planning and business succession, corporate/business structuring, employment discrimination law for employers, banking, creditor’s rights, finance, lender liability defense, covenants not to compete, construction law, mergers and acquisitions and other business matters.
Additional information can be found at www.HKQLaw.com or by calling (800) 760-1529.