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FDA在PPI说明书Warnings/Precautions栏中增加: PPI可增加髋关节,腕关节,脊柱骨折的风险,特别是50岁左右患者。
The FDA has revised labeling for prescription and OTC proton pump inhibitors (PPIs), including Nexium (esomeprazole), Dexilant (dexlansoprazole), Prilosec/Prilosec OTC (omeprazole), Zegerid/Zegerid OTC (omeprazole/sodium bicarbonate), Prevacid /Prevacid 24HR (lansoprazole), Protonix (pantoprazole), Aciphex (rabeprazole), and Vimovo (naproxen/esomeprazole magnesium), to include new safety information about a possible increased risk of hip, wrist, and spine fracture associated with the use of these medications. These medications are indicated to treat conditions such as gastroesophageal reflux disease, stomach and small intestine ulcers, inflammation of the esophagus, frequent heartburn (OTC products), and to decrease the risk of nonsteroidal anti-inflammatory drug–associated gastric ulcers. The new safety information is based on the FDA's review of 7 epidemiological studies that found those at greatest risk for these fractures received high doses of PPIs or had used them for 1 year or more. The majority of the studies evaluated individuals 50 years of age and older, with increased fracture risk primarily observed in this age group. However, randomized clinical trials of PPIs have not found an increased risk of fracture of the hip, wrist, or spine. The revised labeling is included in the Warnings/Precautions section for prescription PPIs and the Drug Facts labeling for OTC PPIs (indicated for 14 days of continuous use). The FDA has also included additional information for consumers and health care providers. Consumers and health care providers should weigh the known benefits against the possible risks when making a decision to use these medications。 |
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