Other safety alerts
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| The United States: FDA drug safety communication: possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors |
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As an update subsequent to the U.S. Food and Drug Administration’s (FDA’s) previous safety announcement released on 25 May 2010, FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low dose PPI use is unlikely. The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.On 25 May 2010, FDA notified the healthcare professionals and patients of revisions to the prescription and OTC labels for PPI to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm
In Hong Kong, there are 140 PPI drugs registered with the Pharmacy and Poisons Board (PPB). All these products are prescription medicines except omeprazole. Regarding the drug safety alert released by FDA in May last year, Department of Health issued letter to healthcare professionals and press release to inform the public on 26 May 2010 and 27 May 2010 respectively.
Ends/ Thursday, March 24, 2011
Issued at HKT 12:30
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