[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.]
[Posted 03/03/2015] ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.
Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting (see http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/ucm404895.htm), FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication at: http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm for additional details.
BACKGROUND: Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, orbrain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.
RECOMMENDATION: Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of the possible increased cardiovascular risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Testosterone topical products may cause harmful effects to people who touch your skin in the area where you applied the gel or solution. Women and children are especially likely to be affected if they touch skin that has been covered with testosterone topical products. If a pregnant woman touches skin that has been covered with testosterone topical products, her unborn baby may be harmed.
You must take precautions to be sure that others will not come into contact with testosterone gel or solution that is on your skin. After you apply testosterone gel or solution, you should allow the medication to dry for a few minutes and then put on clothing that completely covers the area so that no one will touch your bare skin. When you have finished applying the medication, you must wash your hands with soap and water to remove any medication that may be left on your hands.
Do not let anyone touch your skin in the area where you applied testosterone gel or solution. If you expect that you may have skin-to-skin contact with another person, you should wash the area very well with soap and water. If anyone touches skin that has been covered with testosterone gel or solution and has not been washed, that person should wash his or her skin with soap and water as soon as possible. You should also tell others to be careful when handling your clothing, bed linens, or other items that may have testosterone gel or solution on them.
If women or children touch skin that has been treated with testosterone products, they may develop certain symptoms. If a woman who may have come into contact with testosterone develops either of the following symptoms, she should call her doctor immediately: growth of hair in new places on the body or acne. If a child who may have come into contact with testosterone develops any of the following system, you should call the child's doctor immediately: enlarged genitals, growth of pubic hair, increased erections, increased sexual desire, and aggressive behavior. Most of these symptoms can be expected to go away after the child stops coming into contact with testosterone, but in some cases, genitals may remain larger than normal.
Testosterone topical may cause the bones to mature more quickly than normal in children who come into contact with the medication. This means that the children may stop growing sooner than expected and may have a shorter than expected adult height. Even if these children no longer come into contact with testosterone topical products, their bones may remain more mature than normal.
Testosterone topical is used to treat the symptoms of low testosterone in men who do not produce enough natural testosterone. Testosterone is in a class of medications called hormones. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Symptoms of low testosterone include decreased sexual desire and ability, extreme tiredness, low energy, depression, and loss of certain male characteristics such as muscular build and deep voice. Testosterone topical works by replacing the testosterone that is normally produced by the body.
Topical testosterone comes as a gel (AndroGel®, Fortesta®, Testim®, and Vogelxo®) and solution (Axiron®) to apply to the skin. It is usually applied once a day. It is best to apply testosterone gel or solution in the morning. To help you remember to apply testosterone topical, apply it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use testosterone topical exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor.
AndroGel®, Axiron®, Fortesta®, Testim®, and Vogelxo® topical products contain testosterone, but they are manufactured differently and are used in slightly different ways. Be sure that you know which topical brand you are using and how and where you should apply it. Read the manufacturer's patient information that came with your topical testosterone product carefully.
You can apply AndroGel® gel anywhere on your shoulders, upper arms, or abdomen (area between your chest and your waist). You can only apply Axiron® solution to your armpits. You can only apply Fortesta® gel to the front and inside of your thighs. You can apply Testim® and Vogelxo® only to your shoulders or upper arms.You should not apply any of these products to your penis or scrotum or to skin that has sores, cuts, or irritation.
Be careful not to get testosterone topical in your eyes. If you do get testosterone topicalin your eyes, wash them right away with warm, clean water. Call a doctor if your eyes become irritated.
You should not shower, bathe, swim, or wash the place where you applied the medication for at least 2 hours after you apply Axiron® solution or Fortesta®, Testim®, and Vogelxo® gel or at least 5 hours after you apply AndroGel®. If you usually take a bath or shower in the morning, be sure to take your bath or shower before you apply testosterone topical products.
Testosterone topical comes in single use tubes and packets and a multiple use pump. The pump releases a specific amount of testosterone each time the top is pressed. Your doctor or pharmacist will tell you how many times to press the pump for each dose, and how many doses your pump contains. Throw away the pump after you have used that number of doses even if it is not empty.
Testosterone gel and solution may catch fire. Stay away from open flames and do not smoke while you are applying testosterone topical and until the gel or solution has dried completely.
Your doctor may adjust your dose of testosterone depending on the amount of testosterone in your blood during your treatment.
Testosterone topical may control your symptoms but will not cure your condition. Continue to use testosterone topical even if you feel well. Do not stop using testosterone topical without talking to your doctor. If you stop using testosterone topical, your symptoms may return.
Be sure that the skin in the place where you plan to apply testosterone topical is clean and completely dry.
Open your testosterone topical container. If you are using a packet, fold the top edge at the perforation and tear across the packet along the perforation. If you are using a tube, unscrew the cap. If you are using an Androgel®, Axiron®, or Volgelxo® pump for the first time, press down on the top of the pump three times. If you are using a Fortesta® pump for the first time, press down on the top of the pump eight times. Always discard the extra medication that comes out after priming the pump down a drain or in a trash can that is safe from children and pets.
Squeeze the packet or tube or press down on the top of the pump the right number of times to place the medication on the palm of your hand. It may be easier to apply testosterone gel if you squeeze the medication onto your palm and apply it to your skin in small portions. However, if using the Axiron® pump, use the provided applicator to apply the medication; do not use your fingers or hands to apply the medication.
Apply the medication to the area you have chosen.
Throw away the empty packet or tube in a trash can that is safe from children and pets.
Wash your hands with soap and water right away.
Allow the medication to dry for a few minutes before you cover the area with clothing.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed dose.
breast enlargement and/or pain
decreased sexual desire
dry or itchy skin
skin redness or irritation
lower leg pain, swelling or redness
shortness of breath
swelling of the hands, feet, ankles, or lower legs
difficulty breathing, especially during sleep
erections that happen too often or that last too long
difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
skin color changes
yellowing of the skin or eyes
Testosterone topical may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children.
Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of taking this medication.
Testosterone topical may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Store testosterone topical products in a safe place so that no one else can take it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to testosterone.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using testosterone topical.
Do not let anyone else use your medication. Testosterone topical is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 03/15/2015
AHFS® Consumer Medication Information. © Copyright, 2015. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.