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.
Medications similar to oxandrolone may have caused damage to the liver or spleen (a small organ just below the ribs) and tumors in the liver. Tell your doctor if you drink or have ever drunk large amounts of alcohol or used street drugs and if you have or have ever had liver disease. Tell your doctor and pharmacist if you are taking any of the following medications or herbal products: acetaminophen (Tylenol, others), cholesterol lowering medications (statins), comfrey tea, iron products, isoniazid (INH, Nydrazid), kava, methotrexate (Rheumatrex), niacin (nicotinic acid), or rifampin (Rifadin, Rimactane). If you experience any of the following symptoms, call your doctor immediately: upset stomach; extreme tiredness; unusual bruising or bleeding; lack of energy; loss of appetite; pain in the upper right part of the stomach; yellowing of the skin or eyes; flu-like symptoms; pale, cool, or clammy skin; extreme thirst; fast but weak pulse; vomiting; or fast shallow breathing.
Oxandrolone may increase the amount of low density lipoprotein (LDL; 'bad cholesterol') and decrease the amount of high density lipoprotein (HDL; 'good cholesterol') in your blood. This may increase your risk of developing heart disease. Tell your doctor if you or anyone in your family has or has ever had high cholesterol, heart disease, a heart attack, chest pain, or a stroke. Also tell your doctor if you smoke or have ever smoked and if you have high blood pressure or diabetes.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to oxandrolone. Oxandrolone may damage the liver or increase LDL without causing symptoms. It is important to have regular laboratory tests to be sure that the liver is working properly and that LDL has not increased.
Talk to your doctor about the risks of taking oxandrolone.
Why is this medication prescribed?
Oxandrolone is used with a diet and exercise program to cause weight gain in patients who have lost too much weight due to surgery, injury, or long lasting infections, or who are very underweight for unknown reasons. Oxandrolone is also used to treat bone pain in patients with osteoporosis (a condition in which the bones become thin and weak and break easily) and to prevent certain side effects in patients who take corticosteroids (a group of medications used to treat many conditions that involve inflammation or swelling of part of the body for a long time. Oxandrolone is in a class of medications called anabolic steroids. It works by increasing the amount of protein made by the body. This protein is used to build more muscle and increase body weight.
How should this medicine be used?
Oxandrolone comes as a tablet to take by mouth. It is usually taken two to four times a day. To help you remember to take oxandrolone, take it around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxandrolone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably tell you to take oxandralone for 2 to 4 weeks. You may need to take oxandralone for additional 2-4 week periods if your weight decreases again.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking oxandrolone,
- tell your doctor and pharmacist if you are allergic to oxandrolone or any other medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); oral medications for diabetes; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); and steroid creams, lotions, or ointments such as aclometasone (Aclovate), betamethasone (Diprolene, Diprosone, Valisone), clobetasol (temovate), desonide (DesOwen), desoximetasone (Topicort), diflorasone (Psorcon, Florone), fluoxinolone (Derma-Smoothe, Flurosyn, Synalar),fluocinonide (Lidex), flurandrenolide (Cordran), fluticasone (Cutivate), halcinonide (Halog), halobetasol (Ultravate), hydrocortisone (Cortizone, Westcort, others), mometasone (Elocon), and triamcinolone (Aristocort, Kenalog, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had high levels of calcium in your blood, breast or prostate (a male reproductive organ) cancer, enlarged prostate, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking oxandrolone, call your doctor immediately.
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?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Oxandrolone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- difficulty falling asleep or staying asleep
- nervousness or unusual excitement
- changes in sex drive or ability
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately. Some of these side effects may never go away if they are not treated immediately:
- swelling of the arms, hands, feet, ankles or lower legs
- new or worsening acne
- deepening of voice, increase in facial hair, baldness, and changes in genital structures in women
- abnormal menstrual periods
- enlarged penis or erections that come too often or do not go away
- pain, swelling, or decreased size of testes
- enlarged breasts
- frequent, difficult, or painful urination
- bone pain
- slowed heartbeat
- pain on your side (between your stomach and back)
- extreme thirst
- muscle twitches or weakness
- tingling in arms or legs
- weakness or heaviness in legs
- changes in skin color
Oxandrolone may prevent normal growth in children. Children who take oxandrolone may be shorter as adults then they would have been if they had not taken the medication. Oxandrolone is more likely to interfere with the growth of younger children than older children. Your child's doctor will take x-rays regularly to be sure your child is growing normally. Talk to your child's doctor about the risks of giving this medication to your child.
Oxandrolone may decrease fertility in men. Talk to your doctor if your partner plans to become pregnant while you are taking oxandrolone.
Oxandrolone 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.
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.
Symptoms of overdose may include:
- swelling of the arms, hands, feet, ankles, or lower legs
What other information should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking oxandrolone. Oxandrolone may affect the results of certain laboratory tests.
Do not let anyone else take your medication. Oxandrolone has not been shown to improve athletic ability. 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.