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Testosterone Replacement Therapy (TRT) is a hormone replacement therapy which has evolved in recent years and within short period of time it has reached to its highest level of prescriptions in USA. FDA had approved TRT to treat male hypogonadism which means low testosterone levels due to disorders of the testicles, pituitary gland, or brain. Testosterone is made available in forms like topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. TRT may also be prescribed to lessen the effects or delay the onset of normal male aging.
FDA Approved Medications used for treatment of low testosterone include
|ANDROID 10||METANDREN||TESTOSTERONE CYPIONATE|
|ANDROID 25||METHYLTESTOSTERONE||TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE|
|ANDROID 5||NATESTO||TESTOSTERONE ENANTHATE|
|AVEED||ORETON||TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE|
|AXIRON||ORETON METHYL||TESTOSTERONE PROPIONATE|
The manufacturers involved are AbbVie, Actavis, Inc. (formerly Watson Pharmaceuticals), Eli Lilly and Company, Teva Pharmaceuticals, Pharmacia & Upjohn Company, Endo Pharmaceuticals, Columbia Laboratories, Auxilium Pharmaceuticals.
Studies shows that there is an evidence of an increased risk of heart attack or stroke associated with testosterone use especially for AndroGel, Testosterone Therapies.
Major complications of Testosterone Replacement Therapy include
- Acute Myocardial Infarction
- Transient ischemic attacks ("mini-strokes")
- Venous thromboembolism (VTE)- DVT and PE
- Prostate cancer
- Coronary artery disease
Approximately 1,000 men filed lawsuits in February 2014 related to testosterone therapy in which most of the lawsuits filed have been brought against AbbVie, the makers of AndroGel, which is the most widely used and heavily marketed testosterone replacement therapy.
On 3rd March 2015, the FDA announced that all testosterone replacement therapies must have their labels updated after the agency reviewed several studies that suggested men using the "low T" therapies are at an increased risk for heart attacks and strokes.
FDA has pointed out the drug is comparatively prescribed more in men who suffered low testosterone because of aging and not because of any medical condition. Accordingly, FDA has asked the manufacturers to add label and also warned doctors to only prescribe these treatments to men who have had medical tests performed verifying that their low testosterone levels are the result of hypogonadism or another medical issue.
Evidence to be looked for in potential cases
- Indication of Testosterone usage in Medical Records
- Evaluation of Risk and Confounding factors from Past Medical History
- Pharmacy records indicating usage of Testosterone
- Images of Testosterone gels.
- Duration/Formulation of Testosterone usage
- Follow up complications and their treatment after initiation of Testosterone therapy in medical records.
Medical Record Review and claim validation of Testosterone case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.