PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer
AUDIENCE: Consumer
ISSUE: FDA is warning consumers not to purchase or use PNC-27, a product promoted and sold through http://PNC27.com, as a treatment or cure for cancer. An FDA laboratory discovered the bacteria Variovoraxparadoxus in a PNC-27 solution sample for inhalation.
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections. Consumers at higher risk include vulnerable populations, such as young children, elderly people, pregnant women, and individuals with weakened immune systems.
BACKGROUND: PNC-27 may be available in various dosage forms, such as a nebulized solution, intravenous solution, vaginal suppository, or rectal suppository. FDA has not evaluated or approved PNC-27 as safe and effective to treat any disease, including any form of cancer. The agency has not received reports of illnesses or serious adverse events related to PNC-27.
RECOMMENDATION: FDA recommends patients with cancer discuss treatment options with a licensed health care professional. Patients who have used any PNC-27 product and have concerns should contact their health care provider as soon as possible.
Read the MedWatch safety alert, including a link to the FDA Warning statement, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm536763.htm
美國FDA呼籲民眾勿購買或使用PNC-27，此產品為一胜?(peptide)類製品，標榜可治療或治癒癌症。然而美國FDA從PNC-27之吸入液中檢驗出細菌Variovoraxparadoxus。消費者若使用遭汙染的產品，可能會導致嚴重且危及生命的感染。高危險群包含幼兒、老人、孕婦或是免疫力低下的病人。
PNC-27有不同的劑型，包含吸入液、靜脈注射液、陰道塞劑或是肛門栓劑。雖然美國FDA目前尚未接獲任何關於PNC-27之不良反應通報，但此類藥品對於癌症之安全性及有效性尚未被美國FDA評估或核准。
因此，美國FDA建議癌症病人與醫療專業人員討論其疾病治療的選擇，若已使用任何PNC-27產品有疑慮者，建議儘快諮詢醫療專業人員。
相關訊息與連結請參考美國FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm536763.htm
[Posted 01/12/2017]
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
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