Other safety alerts
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| The United States: FDA Drug Safety Communication: Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs) |
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The U.S. Food and Drug Administration (FDA) is informing the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued. Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. Information about the potential risk of low serum magnesium levels from PPIs will be added to the warnings and precautions sections of the labels for all the prescription PPIs.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm245011.htm
In Hong Kong, there are 140 proton pump inhibitor drugs registered. The ingredients include esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole. All these products are prescription medicine except the products containing omeprazole. In view of FDA’s action, letter to inform healthcare professionals about the new safety information will be issued. The issue will be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, March 3, 2011
Issued at HKT 15:30
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