[Posted 01/31/2014]ISSUE: FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.
BACKGROUND: Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.
RECOMMENDATION: At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
For more information visit the FDA website at: Web Siteand Web Site.
Testosterone transdermal patches are used to treat the symptoms of low testosterone in men whose bodies do not produce enough natural testosterone. Testosterone, a hormone that is usually produced by the body, 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 patches work by providing a steady supply of testosterone through the skin to 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 patches 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 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.
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.
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.
Testosterone patches may control your condition but will not cure it. I 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.
To use testosterone patches, follow these steps:
- 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 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.
Before using testosterone patches,
- tell your doctor and pharmacist if you are allergic to testosterone or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin) and insulin (Humalin, Humalog, Novolin, others . Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you or anyone in your family has or has ever had breast or prostate cancer, and if you have or have ever had a blood disorder, diabetes, or heart, kidney, or liver disease.
- you should know that transdermal testosterone is only for use in men. Women should not use this medication, especially if they are or may become pregnant or are breast-feeding. Testosterone may harm the baby.
- tell your doctor if you will be having a magnetic resonance imaging exam (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body). Your doctor will probably tell you to remove your testosterone patch(es) before you have the exam.
- you should know that testosterone patches may be worn during sexual activity. It is very unlikely that your partner will be exposed to more than slight amounts of testosterone. Call a doctor immediately if your female partner develops new or increasing acne, or grows hair in new places on her body.
- you should know that your skin may become irritated in the place where you apply the patch(es). If this happens, you may apply a small amount of hydrocortisone cream to the area after removing your patch(es). Only use hydrocortisone cream; do not use an ointment. If your skin remains irritated after this treatment, call your doctor. Your doctor may prescribe a different cream to apply to the irritated area.
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.
Transdermal testosterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- burn-like blisters, pain, redness, hardness, burning, or itching in the place you applied the patches
- enlarged or tender breasts
- frequent urination
- difficulty urinating
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- erections that happen more than usual or that do not go away
- yellowing of the skin or eyes
- swelling of the ankles
- black, tarry stools
- red blood in stools
- bloody vomit
- vomit that looks like coffee grounds
- difficulty breathing or swallowing
Medications similar to testosterone that are taken by mouth for a long time may cause serious damage to the liver or liver cancer. Transdermal testosterone has not been shown to cause this damage. 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 Web Site] 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).Use testosterone patches immediately after opening the protective pouch. Testosterone patches may burst if exposed to extreme heat or pressure. Do not use damaged patches. Throw away any patches that are outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
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.
Symptoms of overdose may include:
- slow or difficult speech
- weakness or numbness of an arm or leg
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to testosterone. Go to the same laboratory every time that your doctor orders tests because different laboratories may perform the tests in slightly different ways.
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. Ask your pharmacist any questions you have about refilling your prescription.
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.
AHFS® Consumer Medication Information. © Copyright, 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.
Selected Revisions: February 15, 2014.