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?
Fluoxymesterone, an androgenic hormone, is similar to the male hormone testosterone. It is prescribed for males when this hormone is absent or low or to treat delayed onset of puberty in males. It is also used in females with certain kinds of breast cancer.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Fluoxymesterone comes as a tablet to take by mouth. It usually is taken once a day or three or four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluoxymesterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take fluoxymesterone even if you feel well. Do not stop taking fluoxymesterone without talking to your doctor.
What special precautions should I follow?
Before taking fluoxymesterone,
- tell your doctor and pharmacist if you are allergic to fluoxymesterone, tartrazine (a yellow dye in some processed foods and drugs), or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants ('blood thinners') such as warfarin (Coumadin), diabetes medications such as insulin, and vitamins.
- tell your doctor if you have or have ever had diabetes; migraine headaches; heart, liver, or kidney disease; high blood cholesterol or fats; cancer of the breast; depression; enlarged prostate or prostate cancer; or any blood disorder.
- tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding. If you become pregnant while taking fluoxymesterone, call your doctor.
What special dietary instructions should I follow?
Fluoxymesterone may cause an upset stomach. Take fluoxymesterone with food or milk.
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.
Call your doctor for directions if you miss more than one dose.
What side effects can this medication cause?
Fluoxymesterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- enlargement of the breast
- swelling or fluid retention
- absence of menstrual periods
- deepening of the voice or hoarseness
- facial hair growth
- tingling, prickling, burning, or tight sensations
- upset stomach
- increased number and/or duration of penile erections
- decreased sperm production
- increased blood cholesterol
- increased blood calcium
If you experience any of the following symptoms, call your doctor immediately:
- skin rash, itching, or hives
- difficulty breathing
- yellowing of the skin or eyes
- unusual or excessive bleeding
- severe swelling or fluid retention
- difficulty urinating (males)
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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to fluoxymesterone.
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.
¶ This branded product is no longer on the market. Generic alternatives may be available.