The U.S. Food and Drug Administration (FDA) Is Calling On Low Testosterone Drug Companies, Many of whom Are Involved In Low Testosterone Drug Lawsuit Claims, To Conduct Trials To See If There Is A Risk Of Heart Attacks and Strokes When Taking Low Testosterone Drugs.
As low testosterone drug lawsuit claims continue to be filed alleging testosterone drug products such as AndroGel, Androderm, Testim and other prescription Low-T therapy cause men to have heart attacks, strokes and blood clots, the U.S. Food and Drug Administration (FDA) is requiring testosterone manufacturers to conduct a clinical trial on whether there are benefits to men who take the medication to boost their testosterone levels. An article published by FDA officials in the August 20 edition of the New England Journal of Medicine stated the agency was concerned over the cardiovascular risks associated with testosterone products and indicated that advertisements that promote the benefits of testosterone treatment are “unsupported by substantial evidence,” according to a New York Times report. The FDA has approved “Low-T” medication such as AndroGel, Androderm and Axiron to treat a condition known as hypogonadism, which occurs in men with low testosterone levels associated with a medical condition and not due to age. However, the FDA said that most men who take prescription testosterone products do not appear to have hypogonadism, which the agency described as a troubling trend. Besides in its recently published article, the FDA last March, called on testosterone makers to conduct clinical trials on their products. There are currently over 1800 low testosterone drug lawsuits claims pending litigation in the U.S. District Court, Northern District of Illinois (In re: Testosterone Replacement Therapy Product Liability Litigation –MDL No. 2545)
[nytimes.com/2015/08/21/us/trial-of-testosterone-supplements-sought.html?_r=0, August 20, 2015]
“As the discussion continues about the importance of clinical trials, lawsuits continue to be filed by men who are suffering serious cardiovascular events as a result of taking prescription testosterone drugs.” – Southern Med Law
Southern Med Law comprehends the medical and legal questions involved in testosterone drug lawsuit claims which is what makes the law firm able to provide the aggressive and effective advocacy for those who believe they have been harmed by prescription testosterone drugs. If you or someone you love have been injured by testosterone therapy medication, call the office directly at 205-547-5525 for a free, no obligation testosterone therapy lawsuit review or by visiting www.southernmedlaw.com and filling out our online form.
The law firm notes that testosterone products, such as Fortesta and Delatestryl, have been a concern of the FDA. In January 2014, the regulatory agency announced that it was conducting an investigation into the safety and effectiveness of all prescription testosterone gels, creams, patches and injections after reviewing studies and receiving adverse event reports regarding low testosterone treatment products. One study the FDA reviewed was published in JAMA in November 2013. The study indicated that low testosterone treatment medication raises the risk of death, heart attack and stroke by about 30 percent in men who use testosterone products. The FDA also sought input from two of its advisory panels as part of its re-evaluation of testosterone products. The advisory panels suggested that the agency require testosterone makers to conduct new trials to assess the cardiovascular risks associated with testosterone replacement therapy.
[jama.jamanetwork.com/article.aspx?articleid=1764051, November 6, 2013]
[nytimes.com/2014/09/18/health/testosterone-drugs-fda.html?_r=2, September 17, 2014]
In March 2015, the FDA issued a safety alert to announce that the agency was requiring testosterone makers to update the labels of their testosterone products to warn of the possible increase risk of heart attack and stroke in men who are prescribed Low-T medication.
[fda.gov/Drugs/DrugSafety/ucm436259.htm, March 3, 2015]
Court records show that over 2,300 testosterone lawsuit claims have been filed against six manufacturers are pending in the U.S. District Court, Northern District of Illinois, where the cases have been consolidated for coordinated pretrial proceedings. The testosterone treatment lawsuits allege that the defendants misrepresented their testosterone products as a safe and effective way to treat hypogonadism but they failed to disclose the serious cardiovascular and other health risks associated with their testosterone products. As a result, men who are prescribed testosterone products experience heart attack, stroke, blood clots and cardiac death, according to the complaints. The testosterone litigation involves the following defendants:
- AbbVie and Abbott Laboratories, which makes and markets AndroGel
- Actavis, Inc. and Watson Pharmaceuticals manufacturers of AndroDerm
- Auxilium Pharmaceuticals, Inc., which makes Testim
- Endo Pharmaceuticals Inc., which manufactures Delatestryl and Fortesta
- Eli Lilly and Company and Lilly USA LLC, makers of Axiron
- Pfizer Inc. and its subsidiary, Pharmacia & Upjohn Co., which makes and
(In re: Testosterone Replacement Therapy Product Liability Litigation –MDL No. 2545)
About Southern Med Law And Filing A Testosterone Drug Lawsuit
Throughout his career, Southern Med Law’s Founder, Dr. François Blaudeau, has worked hard to develop a strong reputation in healthcare litigation through Southern Med Law. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective legal advocate for those who were harmed due to dangerous and defective drugs. If you believe that you or a loved one was injured by testosterone products, please contact Southern Med Law today to learn more about your legal rights. You can arrange for a free, no obligation testosterone therapy lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Medical Negligence/MedicalDevice/Pharma/Qui Tam