Testosterone Replacement products were silent players of the pharma industry dating back to 1950. Manufacturers such as Allergan, Endo Pharmaceuticals had their heels dug in, but it was a slump until AndroGel, a brand by AbbVie entered the market with a boom in 2011. A year earlier in 2010, Eli Lilly had launched Axiron, but it was AbbVie who introduced the term "Low-T" to the world.
Low testosterone actually means a decrease in testosterone hormone levels in males, which is common after the age of 50. AbbVie specifically targeted this age group to create a superfluous market. People were now concerned about low testosterone levels, and AndroGel was portrayed as a miracle product until the day a realization dawned that Testosterone therapies are actually triggering cardiovascular risks, stroke, and even death in men.
Table of TRT products and their manufacturers
| Name | Type | Manufacturer |
|---|---|---|
| Axiron | Topical solution | Eli Lily |
| Testim | Gel | Auxilium |
| AndroGel | Gel | AbbVie |
| Bio-T-Gel | Gel | Teva |
| Fortesta, Testopel | Gel | Endo |
| Striant | Mucoadhesive | Columbia |
A Quick FLASHBACK
| 1950 | FDA approves first testosterone products for those who lack or have low testosterone levels (genetic problems or chemotherapy; and problems with the hypothalamus and pituitary brain structures) | |
| 2010 | Axiron Launched by Eli Lilly | |
| 2011 | 04/29 | Abbott announces that the FDA has approved AndroGel® (testosterone gel) 1.62%, a clear, odorless, gel formulation, patented till 2015. |
| 2011 | 10/19 | Abbott separates AbbVie as a business initiative and plans it would operate as a research-based pharmaceutical manufacturer, so it is AbbVie the manufacturer for AndroGel from here on Extensive campaigning through an unbranded promotion (the IsItLowT.com site) and awareness-first TV spots. 'Drive for Five' campaign by AbbVie urged men to know their numbers including cholesterol, blood pressure, blood sugar, Prostate-specific antigen- PSA, and testosterone. 49% market share by AndroGel, increased to 65% in later years. |
| 2012 | $1 billion sales mark in nine months; 3.3 million scripts dispensed. | |
| Up to 2014 | AndroGel sales and usage keeps increasing along with Axiron manufactured by Eli Lilly which was following the same trail as AndroGel. | |
| 2013 -2014 | June | Research studies suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy |
| June | AbbVie's AndroGel patent expires. | |
| 2015 | Top players feel the downward sale figures because of patent expiry, perceived risk of cardiovascular or metabolic disease owing to the consumption of TRT products, and FDA safety warning issued. | |
| 2016 | 10/25 | FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic-androgenic steroids (AAS) as it is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. |
| 2017 | 10/25 | FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic-androgenic steroids (AAS) as it is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. |
| 2017 | 03/01 | Perrigo announces FDA's final approval for the generic version of Axiron® Topical Solution, 30 mg/1.5 mL |
| 2014 | 06/05 | AbbVie Inc., the first manufacturer to face trial was whose product AndroGel was the most widely used type of testosterone replacement therapy. The first AbbVie bellwether trial, held on 06/05/2017, was declared as a mistrial. However, 5 other dates have been scheduled for the forthcoming trials: 7/17/2017, 8/28/2017, 10/9/2017, 11/20/2017, and 1/8/2018 |
FDA's Take On The Testosterone Saga:
- May 7, 2009, the FDA announced the requirement for two testosterone replacement gels, AndroGel and Testim, to carry a black-box warning — the FDA’s strongest warning — for secondary exposure in children.
- On January 31, 2014, the FDA released a Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued. The revised labels clarify the approved uses of these medications and include information about a possible increased risk of heart attacks and strokes in patients taking testosterone.
- On June 19, 2014, the FDA required manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins.
- On March 3, 2015, the FDA announced the requirement for labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use.
- October 25, 2016, the 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.
With over 7,000 cases filed against the manufacturers of Testosterone Replacement Therapy (TRT) in the federal court system, this is certainly one of the top Mass Tort litigations. This suit alleges lapse on the part of the manufacturer to issue adequate warnings about the risks of the product, these risks include serious medical conditions such as increased risks of heart attacks, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE).
The trial buzz is on and affected claimants are still contacting law firms to associate with the MDL. Intaking cases is of utmost importance to a law firm, at the same time validating them by way of a thorough review of records to ascertain Proof of Usage (POU) and Proof of Injury (POI) is of equal significance. Evidence to be looked for in potential Low-T cases: Indication of Testosterone usage in Medical Records; Evaluation of Risk and Confounding factors from Past Medical History; Pharmacy records indicating usage of Testosterone Sticker labels of Testosterone gels; Duration/Formulation of Testosterone usage; Follow-up complications and their treatment after initiation of Testosterone therapy in medical records.
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