Newborn Vitamin K Shots: Questions About Package Insert Warnings

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.