[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 transdermal patches are used to treat the symptoms of low testosterone in men whose bodies 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 transdermal patches work by replacing the testosterone that is normally produced by the body.
Transdermal testosterone comes as a patch to apply to the skin. It is usually applied each night between 8:00 p.m. and midnight and left in place for 24 hours. Apply testosterone patches at around the same time every evening. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use testosterone patch(es) exactly as directed. Do not apply more or fewer patches or apply the patches more often than prescribed by your doctor.
Choose a spot on your back, stomach, thighs, or upper arms to apply your patch(es). Be sure that the spot you have chosen is not oily, hairy, likely to perspire heavily, over a bone such as a shoulder or hip, or likely to be under pressure from sitting or sleeping. Do not apply the patch(es) to the scrotum or to a skin area with open sores, wounds, or irritation. Also be sure that the patch will stay flat against the skin and will not be pulled, folded, or stretched during normal activity. Choose a different spot each night and wait at least 7 days before applying another patch to a spot you have already used.
Use testosterone patches immediately after opening. Do not use if the pouch seal is broken or if the patch appears to be damaged. Do not cut the patches.
After you apply the patch(es), do not shower, bathe, swim, or wash the place where you applied the medication for at least 3 hours. Wear your testosterone patch(es) at all times until you are ready to apply the new patch(es). Do not remove your patch(es) before swimming, bathing, showering, or sexual activity.
Exercise or excessive sweating may loosen a patch or cause it to fall off. If a patch becomes loose, smooth it down with your fingers. If a patch falls off before noon, apply a new patch. If a patch falls off after noon, do not apply a new patch until your next scheduled application time that evening. Do not tape the testosterone patch to the skin.
Your doctor may adjust your dose of testosterone depending on the amount of testosterone in your blood during your treatment.
Testosterone patches may control your condition but will not cure it. Continue to use testosterone patches even if you feel well. Do not stop using testosterone patches without talking to your doctor. If you stop using testosterone, your symptoms may return.
Clean and dry the spot where you will apply the patch.
Tear the foil pouch along the edge and remove the patch. Do not open the pouch until you are ready to apply the patch.
Peel the protective liner and silver disc off the patch and throw them away.
Place the patch on your skin with the sticky side down and press down firmly with your palm for 10 seconds. Be sure the patch is completely stuck to your skin, especially around the edges.
When you are ready to remove the patch, pull it off the skin, fold the used patch in half with the sticky sides stuck together, and throw it away in a trash can that is out of the reach of children and pets. Children and pets can be harmed if they chew on or play with used patches.
Apply a new patch immediately by following steps 1-4.
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 patch(es) 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 extra patches to make up for a missed dose.
burn-like blisters, pain, redness, hardness, burning, or itching in the place you applied the patches
enlarged or tender breasts
skin color changes
lower leg pain, swelling or redness
shortness of breath
erections that happen more than usual or that do not go away
swelling of the hands, feet, and ankles
difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
yellowing of the skin or eyes
difficulty breathing, especially at night
Testosterone patches 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 using this medication.
Testosterone may cause other side effects. Call your doctor if you have any unusual problems while using 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). Testosterone patches may burst if exposed to extreme heat or pressure. Throw away any patches that are outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Store testosterone transdermal patches in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many patches are left so you will know if any are missing.
If you wear too many patches, or wear patches for too long, too much testosterone may be absorbed into your bloodstream. In that case, you may experience symptoms of an overdose.
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.
Testosterone can interfere with the results of certain laboratory tests. Before having any tests, tell your doctor and the laboratory personnel that you are using testosterone patches.
Do not let anyone else use your medication. Testosterone transdermal patches are 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.