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Over-The-Counter Eye Drops and Nasal Sprays: Drug Safety Communication - Serious Adverse Events From Accidental Ingestion by Children
AUDIENCE: Pediatrics, Consumer
ISSUE: FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; however, serious events requiring hospitalization such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma have occurred. Ingestion of only a small amount (1-2 mL; for reference, there are 5 mL in a teaspoon) of the eye drops or nasal spray can lead to serious adverse events in young children.
BACKGROUND: Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can accidentally ingest the drug if the bottles are within easy reach. These products are sold under various brand names, as generics, and as store brands (see List of Products, included in the Drug Safety Communication, below).
RECOMMENDATION: Consumers should store these products out of reach of children at all times. If a child accidentally swallows these eye drops or nasal decongestant spray, call the National Capital Poison Center (1-800-222-1222) and seek emergency medical care immediately.
Healthcare professionals and patients are encouraged to report adverse events or side effects 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 links to the Drug Safety Communication and Consumer Update, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA警告醫療專業人員及大眾，兒童誤食一般用來消除紅眼之眼藥水和去鼻充血噴劑可能會造成嚴重且致命的不良反應。
這些眼藥水和鼻噴劑之主要成分為tetrahydrozoline、oxymetazoline，或naphazoline。
此誤食案例發生於五歲以下之兒童，無死亡案例報告，但嚴重至需住院之副作用如噁心、嘔吐、昏睡、心跳加快、呼吸抑制、心跳變慢、低血壓、高血壓、中樞神經 抑制、失眠、瞳孔放大、肢體麻木、體溫降低、流口水和昏厥皆曾發生過。兒童誤食少量此類眼藥水或鼻噴劑（1-2毫升，5毫升為一茶匙）即可導致嚴重的副作 用。
許多消除紅眼的眼藥水和去鼻充血噴劑一般不會有兒童安全包裝，若藥品置放於兒童隨手可得之處則很容易誤食。這些產品具有許多不同的商品名於市面上販售。
消費者應將這些藥品存放於兒童不易取得的地方。若兒童不慎誤食，請趕緊就診。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm325729.htm
[Posted 10/25/2012]
Fungal Meningitis Outbreak
Laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution - have tested positive for bacterial contamination. FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution. These results and the finding of fungal contamination of methylprednisolone acetate reinforce the FDA's concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products.
You can obtain information about the outbreak by calling the FDA's Division of Drug Information line at 855-543-DRUG (3784) or send an email to druginfo@fda.hhs.gov.
Read the MedWatch safety alert, including a link to the FDA Update, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
另兩個額外回收之NECC產品-無防腐劑之betamethasone和心臟麻痺液的化驗結果顯示其有細菌污染。
FDA和CDC實驗室已確認三批NECC提供的無防腐劑藥品betamethasone和一批心臟麻痺液分別測出不同的細菌培養結果。
此結果與發現methylprednisolone acetate有黴菌污染使FDA對NECC調劑機構缺乏無菌的情況感到擔憂，也因此向醫院、診所和醫療機構強調不要使用任何NECC之產品。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm
[Posted 11/01/2012]
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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資料來源：藥師週刊（第1803期）