[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.]
[Posted 03/03/2015]ISSUE:FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.
Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting (see Web Site), FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication at: Web Sitefor additional details.
BACKGROUND:Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, orbrain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.
RECOMMENDATION:Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of the possible increased cardiovascular risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech. For more information visit the FDA website at: Web Siteand Web Site.
Testosterone buccal systems are used to treat symptoms of low testosterone in men who do not produce enough natural testosterone. 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. 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 buccal systems work by replacing testosterone that is normally produced by the body.
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 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 systems.Apply a new system following the directions above.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
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 are overweight or have 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.
Unless your doctor tells you otherwise, continue your normal diet.
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.
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 gumsstinging or swelling of lipsunpleasant or bitter taste in mouthdifficulty tasting foodheadacheacnebreast 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 rednessshortness of breathchest paindifficulty breathing, especially at nightswelling of the hands, feet, and anklessudden unexplained weight gainerections of the penis that happen too often or do not go awaydifficulty urinating, weak urine flow, frequent urination, sudden need to urinate right awayvomitingnauseaskin color changesextreme tirednessyellowing of the skin or eyesdark 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 [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.
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.
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.
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.
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: March 15, 2015.