Testim is a testosterone therapy medication prescribed to men suffering from significantly low levels of testosterone. This medication, produced by Auxilium Pharmaceuticals, was approved in and available since 2002.
Being the main product sold by Auxilium Pharmaceuticals, Testim brought the company $208 million in sales during the year 2011. As sales increase, the number of injuries sustained from the medication grows as well. This rising number of injuries has thousands of victims and their families filing Testim lawsuits in pursuit of compensation and justice from the pharmaceutical companies.
Testosterone regulates growth and the development of male gender characteristics. When applied topically, Testim gel increases bone density and libido, enhances sexual function and increases energy levels. The formulation was designed for use in men aged 18 and older.
Testim Clinical Studies
A physician associated with the Veterans Affairs of Eastern Colorado recently published a study in the Journal of the American Medical Association noting that Testim and similar medications are linked to the development of cardiovascular diseases which can in turn lead to heart attack or stroke.
Auxilium Pharmaceuticals performed clinical trials at more than 70 centers in six countries on more than 600 men diagnosed with hypogonadal disorders. At 43 centers based in the United States, scientists provided 400 volunteers with placebo alternatives. Out of 192 test subjects using the actual medication, 74% of the men demonstrated normalized testosterone levels by the 90th day of treatment.
Adverse Effects of Testim
Dr. Michael Ho reviewed data compiled on 8,700 men aged 60 and above from 2005 to 2011. Prior to receiving topical testosterone therapy, all of the men underwent coronary agiography studies designed for evaluation of vascular health. Though all were diagnosed with abnormally low testosterone levels, only 1,200 men began hormone supplement therapy. The researchers discovered that 26% of the men treated suffered a heart attack or a stroke.
A more recent study evaluated the effects of testosterone therapy on more than 55,000 men under and over the age of 65. The research showed that men under the age of 65 are at a risk three times greater than males that did not undergo any form of treatment.
In lieu of the two published studies, the FDA announced on January 31, 2014, that the administration was in the process of investigating the risks associated with hormone supplementation using Testim and similar products.
The physician-conducted studies published in the Journal of the American Medical Association also indicated that of the more than 11 million men using prescription topical testosterone, only half underwent proper testing for determining low testosterone levels.
Though the FDA issued a warning concerning the safety risks associated with Testim, thousands of men have already suffered serious adverse effects after undergoing treatment. The injuries caused by the medication prompted lawsuits against Auxilium Pharmaceuticals in attempts at obtaining compensation for financial, physical and psychological harm. Suits allege that the company failed to fully disclose the dangers of Testim treatment.