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 buccal systems are used to treat 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 buccal. 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 buccal systems work by replacing testosterone that is normally produced by the body.
How should this medicine be used?
Buccal testosterone comes as a system (tablet shaped patch) to apply to the upper gum. It is usually applied twice a day around every 12 hours. To help you remember to apply testosterone buccal systems, apply them at about the same times each day. It may be convenient to apply the systems after you eat breakfast and brush your teeth, and after dinner. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply testosterone buccal systems exactly as directed. Do not apply more or fewer systems or apply the systems more often than prescribed by your doctor.
You should apply testosterone buccal systems to the areas of your upper gum that are above the left and right incisors (the teeth just to the left and right of the two front teeth). Alternate sides at every dose so that you never apply a system to the same side two doses in a row.
Testosterone buccal systems only work when applied to the upper gum. Although the systems look like tablets, you should not chew or swallow them.
Testosterone buccal systems will soften and mold to the shape of your gum and will gradually release medication. However, they will not dissolve completely in your mouth and must be removed after 12 hours.
You may brush your teeth; use mouthwash; use tobacco products; chew gum; eat; and drink alcoholic or nonalcoholic beverages while you are wearing a testosterone buccal system. However, these activities may cause the system to fall off your gum. After you are finished the activity, check to be sure the system is still in place.
If your testosterone buccal system does not stick or falls off within 8 hours after you apply it, replace it with a new system immediately and apply your next dose at the regularly scheduled time. If your system falls off more than 8 hours after you apply it, apply a new system immediately and do not apply a new system at the regularly scheduled time. The replacement system will take the place of your next dose.
Your doctor may adjust your dose of testosterone depending on the amount of testosterone in your blood during your treatment.
Testosterone buccal systems may control your condition but will not cure it. Continue to use testosterone even if you feel well. Do not stop using testosterone without talking to your doctor. If you stop using testosterone, your symptoms may return.
To apply testosterone buccal systems, follow these steps:
- Push one system out through the back of the blister card. Notice that one side of the system is flat and is marked with the company logo and the other side is curved.
- Place the system on your fingertip with the flat side against your finger.
- Gently press the curved side of the system against the proper area of your upper gum. Push the system as high up on your gum as possible.
- Place your finger on the outside of your upper lip over the spot where you applied the testosterone buccal system. Press down on the spot for 30 seconds to help the system stick to your gum.
- The testosterone buccal system should now be stuck to your gum. If it is stuck to your cheek, you may leave it in place. The system will still release medication properly when stuck to your cheek.
To remove testosterone buccal systems, follow these steps:
- Gently slide the system to the front or back of your mouth to loosen it.
- Slide the system down from your gum to a tooth. Be careful not to scratch your gum.
- Remove the system from your mouth and discard it safely, so that it is out of the reach of children and pets. Children and pets can be harmed if they chew on or play with used systems.
- Apply a new system following the directions above.
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 buccal systems,
- tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in testosterone buccal system. 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. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), insulin (Apridra, Humalog, Humulin, Lantus, Novolin, others), 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 buccal system.
- tell your doctor if you have or have ever had benign prostate hyperplasia (BPH; an enlarged prostate), sleep apnea (a sleep disorder that causes breathing to stop for short periods during sleep), high levels of calcium in your blood, diabetes, or heart, kidney, liver, or lung disease.
- you should know that testosterone buccal systems are 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 fetus.
- you should check your gums regularly while you are using this medication. Call your doctor if you notice any changes in your gums.
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?
Remove the old testosterone buccal system and apply a new one as soon as you remember it. If you remember within 8 hours after the usual application time, keep the new system in place until your next scheduled application time. If you remember more than 8 hours after the usual application time, do not remove the new system at the next scheduled application time.
What side effects can this medication cause?
Testosterone buccal systems may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- irritation, redness, pain, tenderness, swelling, toughening, or blistering of gums
- stinging or swelling of lips
- unpleasant or bitter taste in mouth
- difficulty tasting food
- breast pain or enlargement
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
- chest pain
- difficulty breathing, especially at night
- swelling of the hands, feet, and ankles
- sudden unexplained weight gain
- slow or difficult speech
- dizziness or faintness
- weakness or numbness of an arm or leg
- erections of the penis that happen too often or do not go away
- difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
- extreme tiredness
- yellowing of the skin or eyes
- dark urine
Testosterone buccal systems 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 buccal systems 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).
Store testosterone buccal systems in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many systems 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
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 may order certain lab tests to check your body's response to testosterone buccal systems.
Before having any laboratory tests, tell your doctor and the laboratory personnel that you are using testosterone buccal systems. This medication may affect the results of certain laboratory tests.
Do not let anyone else use your medication. Testosterone buccal systems 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.