AUDIENCE: Patient, Endocrinology, Internal Medicine
ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS.
The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.
The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse. In addition to the new Warning, all testosterone labeling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/AAS, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.
BACKGROUND: Prescription testosterone products are FDA-approved as hormone replacement therapy for men who have low testosterone due to certain medical conditions. Examples of these conditions include failure of the testicles to produce testosterone because of genetic problems, or damage to the testicles from chemotherapy or infection.
RECOMMENDATION: 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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report, available at: http://www.fda.gov/MedWatch/report,
- Download form, available at: /Safety/MedWatch/HowToReport/DownloadForms/default.htm, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Testosterone transdermal patches are used to treat the symptoms of low testosterone in men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland, (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain lab tests to check your testosterone levels to see if they are low before you begin to use testosterone transdermal patches. 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. Testosterone transdermal patches work by replacing the testosterone that is normally produced by the body.
How should this medicine be used?
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.
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 dispose of them.
- 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 dispose of it safely, so that it is out of the reach of 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.
Other uses for this medicine
Testosterone should not be used treat the symptoms of low testosterone in men who have low testosterone due to aging ('age-related hypogonadism').
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using testosterone patches,
- tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in testosterone patches. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or using. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), insulin (Apridra, Humalog, Humulin, Humalog, Lantus, Novolin, others); and oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor will probably tell you that you should not use testosterone transdermal patch.
- tell your doctor if you have or ever had urinary problems due to benign prostate hyperplasia (BPH; an enlarged prostate), high blood levels of calcium, sleep apnea (a sleep disorder that causes breathing to stop for short periods during sleep), diabetes, or lung, 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). If your skin remains irritated after this treatment, call your doctor. Your doctor may prescribe a different cream to apply to the irritated area.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
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.
What side effects can this medication cause?
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
- skin color changes
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- lower leg pain, swelling or redness
- shortness of breath
- slow or difficult speech
- dizziness or faintness
- weakness or numbness of an arm or leg
- chest pain
- 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
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.
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.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
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.
What other information should I know?
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.
¶ This branded product is no longer on the market. Generic alternatives may be available.