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00:00Morning message Friday, June 27th, informed consent Friday. There are
00:09approximately 3.6 million newborns born in the United States every year. The
00:16American Academy of Pediatrics thinks every single one of them should get an
00:22intramuscular dose of vitamin K1. Let's take a look. Here's the package insert
00:31for vitamin K for the newborn. You'll notice right at the top there is a black
00:37box warning. The black box warning is the highest level of warning that the FDA
00:42requires, short of pulling a product from the market. Here's what it says in short.
00:49Severe reactions, including fatalities, have occurred during and immediately
00:54after intravenous and intramuscular injections of vitamin K. Vitamin K is used
01:04to prevent a rare condition known as hemorrhagic disease of the newborn. In the
01:12package insert also is a warning. It says, this product contains aluminum, which
01:19may be toxic. Aluminum may reach toxic levels with prolonged parenteral
01:25administration. Premature neonates are particularly at risk. And then, of course,
01:32is my favorite section, section 13.1. Remember, the American Academy of Pediatrics,
01:40right in the package insert, which is very unusual, is recommending that all newborns
01:45get this product. Section 13.1. Studies of carcinogenicity, mutagenesis, or impairment
01:55of fertility have not been conducted. Translation, we don't know if this product
02:03could lead to cancer or interfere with reproductive health later on in life.
02:08Also in the package insert, deaths have occurred after intramuscular administration, and it refers
02:17back to the black box. Whenever possible, the FDA package insert says vitamin K should be given
02:25by the subcutaneous route. Yet, the American Academy of Pediatrics, right here in the package insert,
02:33recommends an intramuscular dose of vitamin K1. Make this make sense, because I can't.
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