Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use
Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), AcipHex (rabeprazole sodium), and Vimovo (a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen).
Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR (lansoprazole).
AUDIENCE: Consumer, Gastroenterology, Family Practice
FDA notified healthcare professionals and 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). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. 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.
BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.
RECOMMENDATION: 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. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA提醒醫護人員及大眾，長期使用（多為一年以上）氫離子幫浦阻斷劑（proton pump inhibitor, PPI）可能造成低血鎂，而引發嚴重的不良反應事件，包括肌肉痙攣、心律不整及癲癇，然而，上述症狀並不一定會發生，治療低血鎂一般來說需要補充鎂離子，回顧PPI引起的低血鎂的案例中，近四分之一有顯示單獨補充鎂離子無法改善低血鎂而需停用PPI。
PPI可降低胃酸量而用來治療胃食道逆流（gastroesophageal reflux disease, GERD）、腸胃道潰瘍及食道發炎。FDA建議醫療專業人員於預期需長期處方PPI及併用digoxin、利尿劑或可能造成低血鎂藥品的病人，在第一次處方PPI前應監測血中鎂離子濃度，特別是併用digoxin的病人，因為低血鎂可能造成嚴重的副作用，醫療專業人員應考慮上述病人需定期監測血中鎂離子濃度。
FDA提供給病人的資訊如下：
* 若服用處方藥物PPI發生心律不正常，請盡速就醫
* 若曾發生過低血鎂的情形，或併用digoxin、利尿劑或可能造成低血鎂的藥品，請告知醫師
* 醫師可能偶爾會檢測您的血中鎂離子濃度
* 未經醫師指示，勿自行停用PPI
* 對PPI之使用有任何問題請與醫療專業人員討論
* 若服用非處方藥物之PPI，請遵循包裝上之使用說明
* 若長期服用非處方藥物之PPI，請告知醫師
FDA提供給醫療專業人員的資訊如下：
* 預期需長期處方PPI及併用digoxin、利尿劑或可能造成低血鎂藥品的病人，第一次處方PPI前應監測血中鎂離子濃度
* 告知病人若服用PPI後發生心律不整、抽蓄或癲癇等可能是低血鎂之症狀，應立即就醫
* 造成低血鎂的病人應停用PPI，而非補充鎂離子
* 無論病人是自行服用或醫師建議而長期服用非處方藥物之PPI，醫師應告知病人可能造成低血鎂的風險
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245275.htm
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部 |
資料來源：藥師週刊 第1722期