Navigation Links
FDA: Possible Fracture Risk With High Dose, Long-term Use of Proton Pump Inhibitors
Date:5/25/2010

Labeling changes will include new safety information

SILVER SPRING, Md., May 25 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

(Logo:  http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount of acid in the stomach. Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

OTC versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR).

"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 Joyce Korvick, M.D., 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."

FDA's warning and decision to revise the labeling of proton pump inhibitors are based on the Agency's review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist and spine in patients using proton pump inhibitors. Both the Warnings and Precautions section of the prescription labeling and the Drug Facts label on OTC proton pump inhibitors will address these findings.

Health care professionals and consumers should weigh the known benefits against the potential risks of proton pump inhibitors when determining if these medications are appropriate for treatment. Consumers also should talk with their health care professional about any concerns.

Any side effects or other product problems with proton pump inhibitors should be reported to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

For more information

Drug Safety Communication

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm

Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. IDM Pharma Announces Non-Binding Opinion of the European Committee for Medicinal Products for Human Use (CHMP) that Mifamurtide (L-MTP-PE) Provides a Possible Clinical Benefit in Survival
2. Independent Studies Report on Possible Roles for Cylexs Immune Cell Function Assay in Monitoring of Heart and Lung Transplant Recipients
3. New Data Highlighting Possible Impact of ESA Reimbursement Policies on Patient Care, Nations Blood Supply, to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting
4. Study Supports Possible Use of Leukine(R) as a Potential Adjuvant Therapy for High-Risk Melanoma Patients
5. Pediatric Researchers Find Possible Master Switch Gene in Juvenile Arthritis
6. Study Suggests a Possible Way to Offset Chemobrain Memory Loss
7. New Study Shows Cloning from Dried Cells Now Possible
8. Kroger Recalls Peanut Butter Bakery Cookies and Select Cakes Due to Possible Health Risk
9. The Childrens Hospital of Philadelphia: New Gene-Searching Method Uncovers Possible New Targets for Crohns Disease Drugs
10. New Reconstruction Method Makes Speaking, Eating Possible After Tonsil Cancer Surgery, U-M Study Shows
11. FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/17/2017)... Arvinas LLC, a private biotechnology company creating ... today announced the presentation of new preclinical data on ... session at the American Society of Clinical Oncology 2017 ... FL. "The new data ... potential of PROTACs to drive durable and robust responses ...
(Date:2/17/2017)... Research and Markets has announced the addition of ... their offering. ... separate comprehensive analytics for the US, Canada , ... , Latin America , and Rest of World. ... Also, a six-year historic analysis is provided for these markets. Market data ...
(Date:2/17/2017)... 17, 2017  Featuring new and ... the  2017 HIMSS Conference & Exhibition (HIMSS17 ),  Royal ... global leader in health technology,  will ... population health management, acute healthcare informatics ... a highly secure, cloud-based ecosystem. Visitors ...
Breaking Medicine Technology:
(Date:2/17/2017)... ... February 17, 2017 , ... Wells Pharmacy Network offers ... of controlled and non-controlled substances plus the ability to manage orders on their ... States now accept electronic prescriptions, according to the Office of the National Coordinator ...
(Date:2/17/2017)... ... February 17, 2017 , ... ... Carol Francis' goals for each and every seminar, session and class she ... demonstrate five different brainwave tools which help energize creativity, focus mental functions, enhance ...
(Date:2/17/2017)... ... 17, 2017 , ... Access today announced that it will ... February 19-23. Visitors to the company’s booth (#1778) will be the first to ... solution in healthcare . , Since it first introduced Electronic Signature more ...
(Date:2/17/2017)... ... February 17, 2017 , ... Pharmica Consulting attended CHI's 8th ... of clinical trial planning and management. Pharmica discussed the importance of effective project ... attendees stopping by Pharmica’s booth were able to demo its cloud-based Resource ...
(Date:2/17/2017)... GA (PRWEB) , ... February 17, 2017 , ... Like ... to reduce readmissions. Driven in large part by the Hospital Readmission Reduction Program (HRRP), ... been a key focus area for hospitals across the nation. While many providers are ...
Breaking Medicine News(10 mins):