Gibbs Law Group LLP

Testosterone Supplement Products

Testosterone Replacement Therapy Products

Recent studies have found that testosterone replacement therapy (TRT) products have been linked to significant increases in the risk of heart attack, stroke, or death. Research showed there was double the increase in risk of heart attack for men over the age of 65 undergoing TRT. Younger men with prior histories of heart disease and other cardiovascular problems had two to three times the risk.

On January 31, 2014, The FDA issued a safety alert announcing its investigation into the risk of stroke, heart attack, and death in men taking FDA-approved testosterone supplements. None of the FDA-approved testosterone therapy products are approved for use in men with low testosterone levels who do not have an associated medical condition.

Injured by Testosterone Treatment?

If you or a loved one has experienced serious side effects, such as heart attack or stroke after taking prescription testosterone and would like a free, confidential consultation with an attorney, please fill out the form on the right or call toll-free (866) 981-4800.

Common Low T Products

  • Androderm is the only TRT that is supplied as a transdermal patch. It is manufactured by Actavis, Inc., formally known as Watson Pharmaceuticals Inc.
  • AndroGel is a topical gel and is currently the leading Low T product on the market. It is manufactured by AbbVie, Inc.
  • Axiron is a topical gel that is applied to the armpits. It is manufactured by Lilly USA, Inc.
  • Bio-T-Gel is also a gel that is applied directly to the skin. It was approved for sale in February 2012 and is manufactured by Teva Pharmaceutical Industries.
  • Fortesta is a topical gel and is manufactured by Endo Pharmaceuticals, Inc.
  • Striant is a “mucoadhesive” and is designed to adhere to the gums or inner cheek of the patient. Striant is manufactured by Actient Pharmaceuticals, Inc.
  • Testim is a testosterone gel manufactured by Auxilium Pharmaceuticals, Inc.
  • Delatestryl is a testosterone injection manufactured by Endo Pharmaceuticals, Inc.
  • Depo-Testosterone is an injectable medication and is manufactured by Pfizer, Inc.
  • Testopel is the only TRT that is an implantable pellet designed to continually release testosterone to the patient. It is also manufactured by Auxilium Pharmaceuticals, Inc.

Androderm

Androderm is a prescription TRT medication in the form of a transdermal patch, manufactured by TheraTech Inc. and Actavis Inc. (formerly Watson Pharmaceuticals. It was approved for use by the US FDA on September 29, 1995 to treat adult males who have low or no testosterone.

Androderm Application & Side Effects

Androderm is applied topically through a patch which adheres to the skin and are applied nightly for 24 hours. Patches come in two different doses, the 2mg patch or the 4mg patch, the 4 mg patch is the recommended dosage.  Androderm’s most common side effect is listed as skin irritation at the site of the patch. Androderm’s product warning label does not include heart attack, stroke or death in its list of health risks.

Bio-T-Gel

Bio-T-Gel is a prescription TRT medicated gel manufactured by BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. It was approved for use by the US FDA on February 14, 2012 to treat adult males who have low or no testosterone.

Bio-T-Gel Application & Side Effects

Bio-T-Gel is a gel that is applied directly to the skin once daily in the morning to dry, intact skin on the shoulders and upper arms. The recommended dose is 50 mg but the dose can be adjusted between 50 mg and the maximum dose of 100 mg.  Side Effects of Bio-T-Gel include acne, reaction at the application site, and prostatic disorders, but the product warning label does not include heart attack, stroke or death in its list of health risks.

Fortesta

Fortesta is a prescription TRT topical gel manufactured by Endo Pharmaceuticals. It was approved for use by the US FDA on December 29, 2010 to treat adult males who have low or no testosterone.

Fortesta Application & Side Effects

Fortesta is applied to the front and inner thighs the recommended starting dose is 40mg though the dose can be adjusted between a minimum of 10mg and a maximum of 70mg. The Fortesta label states that the most common adverse reaction is skin reactions at the application site, but does not include heart attack, stroke or death in its list of health risks.

Testim

Testim is a prescription TRT topical gel manufactured by Auxilium Pharmaceuticals, Inc. It was approved for use by the US FDA on October 31, 2002 to treat adult males who have low or no testosterone.

Testim Application & Side Effects

Testim is recommended dose is 50mg applied topically to the shoulders and/or upper arms once daily. The most common listed side effects include application site reactions and increased hematocrit, an increase in the red blood cells in the patient’s bloodstream. Testim’s product warning label does not include heart attack, stroke or death in its list of health risks.

Striant

Striant is a prescription TRT medication manufactured by Auxilium Pharmaceuticals, Inc. (previously manufactured by Columbia Laboratories and Actient Pharmaceuticals). It was approved for use by the US FDA on June 19, 2003 to treat adult males who have low or no testosterone.

Striant Application & Side Effects

Striant is a muscoadhesive, meaning it is applied via a pellet adhered to the patient’s gum. The recommended dosage is 30mg to the gum region twice daily (approximately 12 hours between doses). The label lists the most common adverse reactions as gum or mouth irritation pain or tenderness, bitter taste and headaches, the product warning label does not include heart attack, stroke or death in its list of health risks.

Delatestryl

Delatestryl is a prescription TRT injection manufactured by Endo Pharmaceuticals, Inc. (previously manufactured by Indevus Pharmaceuticals, Inc.). It was approved for use by the US FDA on December 24, 1953 to treat adult males who have low or no testosterone.

Delatestryl Application & Side Effects

Delatestryl is applied via injection to the gluteal muscle; suggested dosage is 50-400mg every 2-4 weeks. It is not recommended to inject more than every two weeks or to exceed a total dosage of 400 mg in one month.

Acne, male pattern baldness, nausea, headache, and depression are all listed as adverse reactions to Delatestryl. Delatestryl’s product warning label does not include heart attack, stroke or death in its list of health risks.

Depo-Testosterone

Depo-Testosterone (testosterone cypionate) is a prescription TRT injection manufactured by Pfizer (previously manufactured by Pharmacia and Upjohn Comapny). It was approved for use by the US FDA on July 25, 1979 to treat adult males who have low or no testosterone.

Depo-Testosterone Application & Side Effects

Depo-Testosterone is available in 100mg and 200mg doses, administered via intramuscular injections in the gluteal muscle. The label warns of possible side effects including skin reactions and male pattern baldness.

Testopel

Testopel is a prescription TRT implantable pellet manufactured by Auxilium Pharmaceuticals, Inc. (previously manufactured by Actient Pharmaceuticals). It was approved for use by the US FDA on June 13, 1972 to treat adult males who have low or no testosterone.

Testopel Application & Side Effects

Each testopel pellet contains 75mg of testosterone; the recommended dose is 150-450mg every three to six months. The pellets are implanted by a healthcare provider under the skin in the hip area or another fatty area. Listed side effects include pain and swelling at the implantation site, but Testopel’s product warning label does not include heart attack, stroke or death in its list of health risks.

Injured by Testosterone Treatment?

The personal injury lawyers at Gibbs Law Group LLP are investigating the link between TRT and serious side effects, including heart attacks and strokes. If you or a loved one took testosterone supplements and suffered serious side effects, you may have a legal right to pursue financial compensation for your injuries or other damages.

Fill out the form to the right or call (866) 981-4800 for a free confidential consultation concerning your possible testosterone treatment lawsuit.