[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 buccal systems are 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 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 supplying synthetic testosterone to replace the testosterone that is normally produced naturally.
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 2 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.
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 thow 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, soy, or any other medications.
- 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: insulin (Humulin, Humalog, Novolin, others) or oral steroids such as dexamethasone, (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have a family history of prostate cancer, if you smoke or work with heavy metals such as cadmium, and if you have or have ever had breast or prostate cancer; enlarged prostate; 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 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 gums
- stinging of lips
- unpleasant or bitter taste in mouth
- difficulty tasting food
- stomach pain or cramps
- swelling of nose
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- swelling of the hands, feet, ankles, and lower legs
- sudden unexplained weight gain
- difficulty breathing, especially at night
- erections of the penis that happen too often or do not go away
- upset stomach
- stomach pain or cramping
- loss of appetite
- extreme tiredness
- yellowing of the skin or eyes
- dark urine
- light colored stool
- difficulty urinating
- breast pain or enlargement
- depression or other mood changes
Medications similar to testosterone that are taken by mouth for a long time may cause serious damage to the liver or liver cancer. Testosterone buccal systems have 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 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). Protect this medication from theft. 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 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 take 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.