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FDA Warns Of Overdose Risks With Compounded Wegovy, Ozempic Injections

FDA Warns Of Overdose Risks With Compounded Wegovy, Ozempic Injections

FDA警告複方Wegovy和Ozempic注射劑有過量風險
Benzinga ·  07/30 15:02

The FDA has issued a warning about numerous adverse events, including hospitalizations, stemming from dosing errors and overdoses of compounded semaglutide injectable products, underscoring the risks posed by non-FDA-approved variations.

美國食品藥品監督管理局已發出警告,稱源於複合瑞格列奈注射劑計量錯誤和過量導致多起不良事件,包括入院治療,突顯出非美國食品藥品監督管理局批准的變體所帶來的風險。

These errors often stem from patients incorrectly measuring and self-administering doses and healthcare providers miscalculating doses.

這些錯誤通常源於患者錯誤地測量和自我管理劑量,以及醫療保健提供者計算劑量時出錯。

Also Read: Novo Nordisk's Ozempic Reduces Smoking-Related Health Interventions In Diabetic Patients, Study Finds.

另請參閱:諾和諾德的Ozempic減少了糖尿病患者吸菸相關的健康干預,研究發現。

Novo Nordisk A/S's (NYSE:NVO) semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. There are currently three FDA-approved semaglutide products:

諾和諾德A/S(NYSE: NVO)的瑞格列奈屬於肝素樣胰高血糖素-1(GLP-1)受體激動劑類藥物。目前有三種美國食品藥品監督管理局批准的瑞格列奈產品:

  • Wegovy injection is a single-dose prefilled pen that delivers a preset dose for once-weekly dosing.
  • Ozempic injection is available as multiple-dose prefilled pens for single-patient use, designed for once-weekly dosing.
  • Rybelsus tablets are available as oral tablets for daily dosing.
  • Wegovy注射劑是一種單劑預裝筆,適用於每週一次的劑量。
  • Ozempic注射劑可用作單劑量預裝筆,供單一患者使用,適合每週一次的劑量。
  • Rybelsus片劑可作爲口服片劑,每日劑量。

Mistakes often involved unfamiliarity with drawing medication from a vial into a syringe and confusion over different units of measurement such as milliliters, milligrams, and "units."

錯誤通常涉及從瓶中抽取藥物到注射器中的不熟悉程度,並對不同的測量單位,如毫升,毫克和“單位”感到困惑。

"Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports," the FDA said in a July 26 statement.

美國食品藥品監督管理局在7月26日的聲明中表示:“在複合瑞格列奈瓶中接受注射的許多患者缺乏自行注射的經驗。”

The prescribing information for FDA-approved semaglutide injections includes overdose risks, such as severe nausea, vomiting, and hypoglycemia, which may require prolonged observation and treatment due to the drug's long half-life.

美國食品藥品監督管理局批准的瑞格列奈注射劑的處方信息包括過量風險,如嚴重噁心,嘔吐和低血糖,可能需要長時間觀察和治療,因爲這種藥物的半衰期較長。

FDA has noted compounded semaglutide products marketed for weight loss, which pose higher risks because they do not undergo FDA premarket review.

美國食品藥品監督管理局已經注意到銷售用於減肥的複合瑞格列奈產品,因爲它們不需要進行美國食品藥品監督管理局前市場審查,所以它們存在更高的風險。

Compounded semaglutide products can vary significantly from approved products in packaging, concentration, and administration instructions. Variations include multiple-dose vials, prefilled syringes, and differing concentrations from various compounders.

複合瑞格列奈產品可以在包裝,濃度和使用說明方面與批准的產品存在顯着的差異。其中包括多劑瓶,預裝注射器和不同合成劑的不同濃度。

Reports to the FDA highlighted errors with compounded semaglutide in multiple-dose vials, resulting in patients drawing up more than the prescribed dose. These instances often involved patients administering five to 20 times the intended dose, primarily due to unfamiliarity with syringe measurements.

向美國食品藥品監督管理局彙報的有關複合瑞格列奈的錯誤強調了多劑瓶中的問題,導致患者注射了超過規定劑量的藥物。這些情況通常涉及患者由於對注射器測量的陌生而給予了比預定劑量高5到20倍的劑量。

FDA-approved semaglutide products, available in prefilled pens with standard concentrations, avoid these issues.

美國食品藥品監督管理局批准的瑞格列奈產品具有標準濃度的預裝筆,避免了這些問題。

However, compounded versions with various concentrations have led to healthcare providers miscalculating doses, sometimes by significant margins.

然而,不同濃度的複合版本導致醫療保健提供者計算劑量時出現錯誤,有時誤差很大。

Price Action: NVO stock is up 0.43% at $128.59 at last check Tuesday.

NVO股票於上週二最後交易時上漲0.43%至128.59美元。

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Photo: Tobias Arhelger/Shutterstock.com

圖片來源:Tobias Arhelger / Shutterstock.com

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