ジャヌビアで膵炎(1)

 
スポンサーリンク


  糖尿病の新薬DPP-4阻害薬sitagliptin(ジャヌビア、萬有製薬)に関して、FDAで安全性情報が出ています。
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Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis

[Posted 09/25/2009] FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.
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88例の急性膵炎

  2006年から2009年で88例の急性膵炎を発症し、うち2例は出血性・壊死性膵炎であったとのこと。投与開始時や増量時には注意深い経過観察が必要、とのことです。

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