AndroGel is manufactured by AbbVie Inc., and was released in the United States in 2000. Approved for primary hypogonadism or hypogonadotropic hypogonadism, AndroGel was aggressively marketed and prescribed off-label and became prescribed to millions of Americans.
As noted by the FDA in their January 31, 2014 notice, AndroGel and other “testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.”
Millions of Americans were prescribed AndroGel 1% or AndroGel 1.62% without any warning of risks of stroke, heart attack, pulmonary embolisms, or death, with only a blood test for low testosterone without any corresponding associated medical condition.
Learn More about Filing an Androgel Lawsuit
The FDA is now evaluating the risk of heart attack, stroke, and death with AndroGel and other testosterone products.
If you or a love one has been injured while taking testosterone replacement therapy, please contact our experienced pharmaceutical attorneys at Levin Simes LLP for a free case review and legal consultation. Contact Levin Simes LLP toll-free at 1 (888) 426-4156, or contact us online by completing the free consultation form on this page.