Androgel 1.62%

Testosterone

For Low Testosterone

Track record

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Medium (approved in 2011)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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Low Testosterone

What is Low Testosterone?

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Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.

Other treatments for Low Testosterone

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

FDA-approved use

To treat low testosterone levels caused by a medical condition

Who might consider taking it?

Men with low testosterone caused by a medical condition

Men (age 18 or older) with low testosterone (level less than 300ng/dL) from medical conditions such as undescended testes, pituitary tumors, damage to testes from trauma, chemotherapy or radiation

What is not known

FDA has NOT approved Androgel 1.62% for "Low-T" just from aging because the benefits and harms are not known

It is not known if Androgel 1.62% - or any testosterone treatment - increases the chance of prostate cancer, heart disease or stroke

Track record

MEDIUM TRACK RECORD

Medium track record for this form of the drug means that new, unexpected side effects are possible. Testosterone was first approved by FDA in 1953 but the gel form - Androgel 1.62% - was only approved in 2011 based on studies where about where about 200 people took approved doses of the drug for 6 months. Rare but serious side effects may emerge when a drug is given in a new form.

Open questions

Ongoing studies FDA required to answer questions about harms

FDA is requiring that the manufacturers of all testosterone products including Androgel 1.62% conduct a randomized trial to see whether these drugs increase the chance of heart attack or stroke

Do not take if you...

Have breast cancer

Have or are suspected to have prostate cancer

Are younger than age 18

Children should not use or have contact with Androgel 1.62% - it can cause premature puberty (enlarged penis or clitoris, early public hair, increased erections or sex drive, or aggressive behavior)

Are female

Women should not use or have contact with Androgel 1.62% - because it can cause masculine body changes (changes in hair distribution and increase in acne) and it can harm the baby if they are pregnant.

Safe if pregnant or breastfeeding?

Pregnant

Do not take: Controlled human studies show Androgel 1.62% harms baby and potential benefits do not outweigh potential harms (FDA Category X)

Breastfeeding

Do not breastfeed - Androgel 1.62% gets into breast milk and can harm baby

NEXT: TRIALS

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