Axiron

Testosterone

For Low Testosterone

Track record

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Medium (approved in 2010)

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

Bottom Line

The FDA only approved Axiron for men with low testosterone from a medical condition - not for men with low-testosterone from aging

For men with low testosterone because of a medical problem (trauma, chemotherapy, genetic abnormalities, undescended testes or some other serious underlying problem), testosterone has important benefits. It helps them develop normally or to restore "maleness" and sexual function.

For men with low testosterone from aging, the FDA required Axiron - and all testosterone products - to make clear that the drug is not approved for them. That's because the benefits and safety are not known.

Axiron has serious side effects

In 2015, the FDA required all testosterone products to include a warning that these drugs might cause more heart attack and strokes.

Axiron is known to have other serious side effects. It can cause abnormally high red blood cell counts that can lead to strokes, fatal blood clots in the legs and lungs and serious liver damage, and it may increase prostate cancer. Axiron can also worsen symptoms from an enlarged prostate, cause leg or ankle swelling (especially in people with heart, kidney or liver disease), cause painful enlargement of breast tissue, worsen sleep apnea (especially in men who are obese or who have chronic lung problems), raise bad cholesterol, and cause dangerously high calcium levels in people with certain kinds of cancer. It can also lower sperm counts, which could affect fertility.

Lifestyle changes

Axiron is applied as an underarm roll-on once a day. Because women and children exposed to it can be seriously harmed, men who use Axiron need to follow strict precautions: they have to wash their hands with soap immediately after applying Axiron, cover the application site with clothing after the solution has dried and make sure that women and children do not have direct skin-to-skin contact with the armpit area after Axiron is used. The FDA is so concerned about possible harm to children from exposure to Axiron that they include their highest level of warning - a "black box" warning - on the label. Possible harms include early puberty in children and masculine body changes in women.

Because Axiron is flammable, men should avoid smoking, fires and flames until the Axiron dose has dried completely. Men also need to avoid swimming or washing the armpit area for at least 2 hours after applying Axiron.

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 Axiron for "Low-T of Aging" because the benefits and harms are not known

It is not known if Axiron - 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 (the active ingredient in Axiron) was first approved by FDA in 1953 - but the topical solution form - Axiron - was only approved in 2010 based on studies where about where about 200 people took approved doses of the drug for up to 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 Axiron 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 Axiron - 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 Axiron 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 Axiron harms baby and potential benefits do not outweigh potential harms (FDA Category X)

Breastfeeding

Do not breastfeed - Axiron gets into breast milk and can harm baby

NEXT: TRIALS

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