Our firm has requested that the FDA take action to prevent off-label use of testosterone therapy drugs, including AndroGel, AndroDerm, Axiron, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim and Testopel.LEARN MOREFDA Asked to Prevent Off-Label Use of Low-T Drugs
Patients who are using testosterone therapy drugs are at risk of dangerous side effects, including heart attack, stroke, pulmonary embolism, transient ischemic attacks (mini-strokes), coronary artery disease and death.LEARN MORESide Effects of Testosterone and Low-T Drugs
A study conducted by UCLA and the National Institutes of Health and Consolidated Research found that testosterone therapy drugs substantially increase the risk of heart attack. The comprehensive study followed 56,000 men over a three year period.LEARN MOREStudy Reveals Elevated Heart Attack Risk
Find the latest news on lawsuits against manufacturers of Low-T drugs and the status of the consolidated multidistrict litigation ("MDL") cases pending in the U.S. District Court for the Northern District of Illinois.LEARN MORELatest News on Lawsuits Involving Low-T Drugs
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Testosterone Low-T Lawsuit
July 30, 2014—In light of the risks of testosterone therapy drugs, today we asked the federal Food and Drug Administration (FDA) to take action to prevent off-label use of the testosterone therapy drugs AndroGel, AndroDerm, Axiron, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim and Testopel.
"Off-label use" is a term that applies to the practice of of prescribing a drug for uses, time periods or dosages that have not been approved by the FDA.
Side Effects of Testosterone Therapy Drugs
Heart attacks, strokes and pulmonary embolisms have been associated with the use of various Low-T drugs, including:
- AndroGel (AbbVie, formerly a division of Abbott Laboratories)
Testosterone therapy gel applied directly to the skin.
- AndroDerm (Actavis plc, formerly known as Watson Pharmaceuticals, Inc.)
Testosterone treatment patch or film that delivers medication through the skin.
- Axiron (Eli Lilly and Company)
Testosterone therapy gel which is applied to the armpits.
- Bio-T-Gel (GlaxoSmithKline plc)
Testosterone treatment gel that is applied to the skin.
- Delatestryl (Savient Pharmaceuticals, Inc.)
Injectable testosterone drug.
- Depo-Testosterone (Pfizer, Inc.)
Injectable testosterone pharmaceutical.
- Fortesta (Endo Pharmaceuticals, Inc.)
Testosterone spray gel that is applied directly to the skin.
- Striant (Mipharm S.p.A. for Columbia Laboratories, Inc.)
Time release testosterone tablet.
- Testim (Auxilium Pharmaceuticals, Inc.)
Testosterone therapy gel that is applied to the skin.
- Testopel (Slate Pharmaceuticals, Inc.)
Slow release testosterone implant that is inserted under the skin.
About Testosterone Therapy Medications
Testosterone therapy medications have been approved by the federal Food and Drug Administration (FDA) for treatment of men who have been diagnosed with hypogonadism, a medical condition in which the body fails to produce adequate levels of testosterone. As a result of marketing campaigns directed to consumers, however, many physicians are prescribing testosterone drugs "off-label" to men who are experiencing only natural age-related declines in their testosterone production. This illegal practice has resulted in an enormous growth in testosterone therapy sales for the benefit of manufacturers of the products.
Various claims are made for testosterone treatment drugs including assertions that they will improve sex drive and performance, produce increased muscle growth, reduce body fat and build stronger bones.
Medical research reveals, however, that men who use testosterone drugs are at a substantially greater risk of heart attack, stroke and death than are men who do not use the Low-T therapies.
Pending lawsuits against drug manufacturers allege, among others, that manufacturers failed to properly research the potential side effects of testosterone drugs, concealed critical information about their serious side effects, and improperly marketed these drugs to consumers.
About Our Firm
We Would Like to Help You
Our firm is handling legal claims on behalf of those harmed by testosterone therapy medications, including AndroGel, AndroDerm, Axiron, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim, or Testopel. We invite you to contact us for a free, confidential consultation about your legal rights. We represent patients throughout the United States. We can help you, too, wherever you live.
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What You Should Do
If you have taken AndroGel, AndroDerm, Axiron, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim, or Testopel, and you are concerned about your health, promptly consult your physician for an evaluation. Do not discontinue testosterone drug treatment without first consulting your physician.
Testosterone Therapy Lawsuit News
More than 150 lawsuits already have been filed against manufacturers of low testosterone therapy drugs in the U.S. District Court for the Northern District of Illinois. This is the court in which low-T drug litigation has been consolidated into what is called "multidistrict litigation (MDL)" in the federal court system.
Phoenix attorney Jonathan O'Steen has asked the federal Food and Drug Administration (FDA) to take action to prevent off-label use of the testosterone therapy drugs AndroGel, AndroDerm, Axiron, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim and Testopel.
In June, all testosterone therapy lawsuits previously filed in various federal courts throughout the United States were consolidated in a single court—the U.S. District Court for the Northern District of Illinois. The advantages of consolidation include efficiency, resource conservation, reduction of duplication in the trial preparation process and elimination of the possibility of conflicting rulings among different courts.