[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.
Testosterone gel may cause harmful effects to people who touch your skin in the area where you applied it. Women and children are especially likely to be affected if they touch skin that has been covered with testosterone gel. If a pregnant woman touches skin that has been covered with testosterone gel, her unborn baby may be harmed.
You must take precautions to be sure that others will not come into contact with testosterone gel that is on your skin. After you apply testosterone gel, 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. 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 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 on them.
If women or children touch skin that has been treated with testosterone gel, they may develop certain symptoms. If a woman who may have come into contact with testosterone gel 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 gel 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 gel, but in some cases, genitals may remain larger than normal.
Testosterone gel 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 gel, their bones may remain more mature than normal.
Testosterone topical gel is used to treat the symptoms of low testosterone in men who do not produce enough natural testosterone. Testosterone is a hormone that is usually produced by the body that is needed for the growth and functioning of the male sexual organs and for the development of typical male characteristics. Symptoms of low testosterone include decreased sexual desire and ability, extreme tiredness, low energy, depression, brittle bones that may break easily, and loss of certain male characteristics such as muscular build and deep voice. Testosterone gel works by supplying testosterone to replace the testosterone that is normally produced in the body.
Topical testosterone comes as a gel to apply to the skin. It is usually applied once a day. It is best to apply testosterone gel in the morning. To help you remember to apply testosterone gel, 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 gel exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor.
AndroGel®and Testim®brand gels both contain testosterone, but they are manufactured differently and are used in slightly different ways. Be sure that you know which brand of gel you are using and how and where you should apply it. Read the manufacturer's patient information that came with your gel carefully.
You can apply AndroGel®anywhere on your shoulders, upper arms, or abdomen (area between your chest and your waist). You can apply Testim®anywhere on your shoulders or upper arms, but you shouldnotapply it to your abdomen. You shouldnotapply either gel to your penis or scrotum or to skin that has sores, cuts, or irritation.
Be careful not to get testosterone gel in your eyes. If you do get testosterone gel in 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 Testim®gel or at least 5-6 hours after you apply AndroGel®. Once in while, you may shower, bathe or swim as soon as 1 hour after you apply Testim®, but you should usually wait the full 2 hours. If you usually take a bath or shower in the morning, be sure to take your bath or shower before you apply either brand of testosterone gel.
Testosterone gel comes in single use tubes and packets and a multiple use pump. The pump releases a specific amount of testosterone gel each time the top is pressed. You will probably need to press the top of the pump four to eight times to get your full dose of testosterone gel. 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 may catch fire. Stay away from open flames and do not smoke while you are applying testosterone gel and until the gel has dried completely.
Your doctor may adjust your dose of testosterone gel depending on the amount of testosterone in your blood during your treatment.
Testosterone gel may control your symptoms but will not cure your condition. Continue to use testosterone gel even if you feel well. Do not stop using testosterone gel without talking to your doctor. If you stop using testosterone gel, your symptoms may return.
To use testosterone gel, follow these steps:
- Be sure that the skin in the place where you plan to apply testosterone gel is clean and completely dry.
- Open your container of testosterone gel. 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 a pump for the first time, press down on the top of the pump three times and discard the medication that comes out 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.
- 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.
Before using testosterone gel,
- tell your doctor and pharmacist if you are allergic to testosterone, any other medications, alcohol products, or soy.
- 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); cosyntropin (Cosyntropin); inhaled steroids such as beclomethasone (QVAR), budesonide (Pulmicort, Rhinocort), flunisolide (AeroBid), fluticasone (Flovent, in Advair), and triamcinolone (Azmacort); insulin (Humalin, Humalog, Novolin, others); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); propranolol (Inderal); and steroid creams, lotions, or ointments such as alclometasone (Aclovate), betamethasone (Diprolene, Diprosone, Valisone), clobetasol (Temovate), desonide (DesOwen), desoximetasone (Topicort), diflorasone (Psorcon, Florone), fluocinolone (Derma-Smoothe, Flurosyn, Synalar), fluocinonide (Lidex), flurandrenolide (Cordran), fluticasone (Cutivate), halcinonide (Halog), halobetasol (Ultravate), hydrocortisone (Cortizone, Westcort, others), mometasone (Elocon), and triamcinolone (Aristocort). 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 prostate (a male reproductive gland) cancer, or if a doctor has told you that you might have prostate cancer and if you have or have ever had sleep apnea (breathing stops for short periods of time during sleep), an enlarged prostate, breast cancer, diabetes, or heart, kidney, liver, or lung disease.
- you should know that testosterone gel 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.
Unless your doctor tells you otherwise, continue your normal diet.
If your next scheduled dose is not due for 12 hours or longer, apply the missed dose as soon as you remember it. However, if your next dose is due in less than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.
Testosterone gel 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
- hair loss
- hot flushes
- mood changes
- difficulty falling asleep or staying asleep
- teary eyes
- changes in ability to smell or taste
- dry skin
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- swelling of the hands, feet, ankles, or lower legs
- breathing problems, especially during sleep
- erections that happen too often or that last too long
- difficulty urinating
- weak urine flow
- sudden need to urinate right away
- frequent urination, especially at night
- yellow or darkened skin
Medications similar to testosterone that are taken by mouth for a long time may cause serious damage to the liver or liver cancer. Testosterone gel 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 taking this medication.
Testosterone gel 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 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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
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 gel.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using testosterone gel.
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.