Suntikan Vitamin K untuk Bayi Baru Lahir: Pertanyaan tentang Peringatan Produk
3 min Machine translated About United States Health
3 min Machine translated About United States Health
Setiap tahun, sekitar 3,6 juta bayi baru lahir lahir di Amerika Serikat.
American Academy of Pediatrics berpendapat setiap bayi itu harus mendapat suntikan intramuskular vitamin K1.
Mari kita lihat. Ini adalah lembar informasi vitamin K untuk bayi baru lahir.
Perhatikan bagian paling atas, ada peringatan kotak hitam.
Peringatan kotak hitam adalah tingkat peringatan tertinggi yang diwajibkan FDA, sebelum produk ditarik dari pasaran.
Singkatnya, bunyinya begini. Reaksi berat, termasuk kematian, telah terjadi selama dan segera setelah suntikan vitamin K secara intravena dan intramuskular.
Vitamin K digunakan untuk mencegah kondisi langka yang dikenal sebagai penyakit perdarahan pada bayi baru lahir.
Lembar informasi itu juga memuat peringatan.
Tertulis, "Produk ini mengandung aluminium, yang mungkin beracun.
Aluminium dapat mencapai kadar beracun jika diberikan secara parenteral dalam waktu lama.
Bayi prematur sangat berisiko. Dan tentu saja, bagian favorit saya, bagian 13.1. Ingat, American Academy of Pediatrics, tepat di dalam sisipan kemasan, yang sangat tidak lazim, merekomendasikan agar semua bayi baru lahir mendapatkan produk ini.
Bagian 13.1, "Studi tentang karsinogenisitas, mutagenesis, atau gangguan kesuburan belum dilakukan."
Artinya: kita tidak tahu apakah produk ini dapat menyebabkan kanker atau mengganggu kesehatan reproduksi di kemudian hari.
Juga di dalam sisipan kemasan, "Kematian telah terjadi setelah pemberian intramuskular," dan itu merujuk kembali ke kotak peringatan.
"Jika memungkinkan," bunyi sisipan kemasan FDA, "Vitamin K harus diberikan melalui rute subkutan."
Namun, American Academy of Pediatrics, tepat di sini, dalam sisipan kemasan, merekomendasikan dosis intramuskular vitamin K1.
Tolong jelaskan ini, karena aku tidak bisa.
End of transcript · 241 words · machine translated
There are approximately 3.6 million newborns born in the United States every year.
The American Academy of Pediatrics thinks every single one of them should get an intramuscular dose of vitamin K1.
Let's take a look. Here's the package insert for vitamin K for the newborn.
You'll notice right at the top, there is a black box warning.
The black box warning is the highest level of warning that the FDA requires, short of pulling a product from the market.
Here's what it says in short. Severe reactions, including fatalities, have occurred during and immediately after intravenous and intramuscular injections of vitamin K. Vitamin K is used to prevent a rare condition known as hemorrhagic disease of the newborn.
In the package insert also is a warning.
It says, "This product contains aluminum, which may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration.
Premature neonates are particularly at risk."
And then, of course, is my favorite section, section 13.1. Remember, the American Academy of Pediatrics, right in the package insert, which is very unusual, is recommending that all newborns get this product.
Section 13.1, "Studies of carcinogenicity, mutagenesis, or impairment of fertility have not been conducted."
Translation: we don't know if this product could lead to cancer or interfere with reproductive health later on in life.
Also in the package insert, "Deaths have occurred after intramuscular administration," and it refers back to the black box.
"Whenever possible," the FDA package insert says, "vitamin K should be given by the subcutaneous route."
Yet, the American Academy of Pediatrics, right here in the package insert, recommends an intramuscular dose of vitamin K1.
Make this make sense, because I can't.
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