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.
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.
Why is this medication prescribed?
Testosterone topical is 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 tests to check your testosterone levels to see if they are low before you begin to use testosterone topical.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 topical works by replacing the testosterone that is normally produced by the body.
How should this medicine be used?
Topical testosterone comes as a gel and solution 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.
Testosterone topical products 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.
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. Read the manufacturer's patient information about your topical testosterone product for information about when you can wash, shower, bath, or swim after you apply the medication.
You should not apply any testosterone topical 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 topical in your eyes, wash them right away with warm, clean water. Call a doctor if your eyes become irritated.
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. Dispose of 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.
To use testosterone topical products, follow these steps:
- 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.
- Dispose of the empty packet or tube in a trash can safely, out of the reach of 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.
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 gel,
- tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in topical testosterone products. 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 plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven); insulin (Apridra, Humalog, Humulin, 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 topical.
- tell your doctor if you have or have ever had sleep apnea (breathing stops for short periods of time during sleep), benign prostate hyperplasia (BPH; an enlarged prostate); high blood levels of calcium; diabetes; or heart, kidney, liver, or lung disease.
- you should know that testosterone topical is only for use in men. Women should not use this medication, especially if they are or may become pregnant or are breastfeeding. Testosterone may harm the fetus.
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 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.
What side effects can this medication cause?
Testosterone topical may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- breast enlargement and/or pain
- decreased sexual desire
- mood changes
- teary eyes
- dry or itchy skin
- skin redness or irritation
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- lower leg pain, swelling or redness
- shortness of breath
- swelling of the hands, feet, ankles, or lower legs
- slow or difficult speech
- dizziness or faintness
- weakness or numbness of an arm or leg
- chest pain
- 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 (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).
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.
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 emergency/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.
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.