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.
Do not take danazol if you are pregnant or breast-feeding. A method of birth control (contraception) other than oral contraceptives should be used while taking danazol. If you become pregnant, call your doctor immediately. Life-threatening strokes, increased pressure in the brain, and serious liver disease complicated by potentially life-threatening abdominal bleeding have been reported during therapy with danazol. Talk to your doctor about the potential risks associated with this medication.
Why is this medication prescribed?
Danazol is used to treat endometriosis, a disease that causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding. Danazol is also used in fibrocystic breast disease to reduce breast pain, tenderness, and nodules (lumps). Danazol is also used to prevent attacks of angioedema in both males and females.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Danazol comes as a capsule to take by mouth. It usually is taken twice a day. Women should take the first dose during a menstrual period and take it continuously thereafter. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take danazol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not stop taking danazol without talking to your doctor. If you have fibrocystic breast disease, breast pain and tenderness usually improve during the first month that you take danazol and go away in 2 to 3 months; nodules should improve in 4 to 6 months.
What special precautions should I follow?
Before taking danzaol,
- tell your doctor and pharmacist if you are allergic to danazol 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; medications to prevent seizures, especially carbamazepine (Tegretol); and vitamins.
- tell your doctor if you have or have ever had migraine headaches; heart, liver, or kidney disease; seizures (epilepsy); or a history of stroke, blood clots, or breast cancer.
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?
Danazol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- decrease in breast size
- deepening of the voice, hoarseness, or sore throat
- weight gain
- swelling (water retention and bloating)
- oily skin or hair
- hair growth in unusual amounts and places
- vaginal dryness, burning, itching, or bleeding
- absence of menstrual cycle, spotting, or change in menstrual cycle
If you experience any of the following symptoms, call your doctor immediately:
- skin rash
- yellowing of the skin or eyes
- persistent headache
- persistent upset stomach
- visual disturbances
- persistent abdominal pain
- for males, frequent, prolonged, or painful penile erections
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.
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. You probably will have periodic blood tests; men also may have semen tests. Your doctor may change your dose, depending on your response to the medication.
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.