FDA Seeks Answers From Advisory Panels As Testosterone Lawsuits Mount Against "Low T" Drug Makers
The FDA Continues Its Investigation Into Low Testosterone Products As Testosterone Lawsuits Mount And Is Seeking Input From Its Advisory Panels On Reports That Low Testosterone Medication, Such As AndroGel and Androderm, Allegedly Cause Heart Attacks And
[fda.gov/AdvisoryCommittees/Calendar/ucm404905.htm, July 17, 2014]
[fda.gov/AdvisoryCommittees/Calendar/ucm406131.htm, July 22, 2014]
The testosterone attorneys at Wright & Schulte continue speak with men who have purportedly experienced side-effects from low testosterone treatment drugs such as heart attacks, strokes, and blood clots to the lungs and legs. The firm also continues to off free testosterone lawsuit legal evaluations by calling 1-800-399-0795 or you can visit www.yourlegalhelp.com for more information.
According to court records there are currently over 150 testosterone treatment lawsuits filed in an industrywide consolidation of all testosterone lawsuits that were filed in federal courts across the country on behalf of men who allege that they suffered strokes, heart attacks and death as a result of taking prescribed low testosterone medication. (In Re: Testosterone Products Liability Litigation, No. 42, JPML) The lawsuits name the makers of such testosterone drugs as AndroGel, Androderm, Axiron, and Testim as defendants. Among the 150 plus testosterone therapy lawsuits filed, one was filed on behalf of a Louisiana man who contends he suffered two strokes as a result of using AndroGel and Testim. This testosterone replacement lawsuit was filed under JPML 42 and asks for damages from AbbVie Inc. and Abbot Laboratories, which manufactures and markets AndroGel, and Auxilium Pharmaceuticals, Inc., which manufactures Testim. According to the lawsuit, the Louisiana man did not have cardiac problems prior to being prescribed AndroGel and Testim for low testosterone treatment in 2006 when he was 65 years old. The plaintiff continued taking AndroGel and Testim until 2014. The testosterone complaint contends that had the Louisiana man known about the risks of testosterone replacement therapy, he would no have had to suffer the side-effects of the medication. (In Re: Testosterone Products Liability Litigation, No. 42, JPML)
In addition to the growing testosterone lawsuits in the United States, the FDA’s meeting announcement comes on the heels of a testosterone therapy drug warning issued by Health Canada on July 15th that testosterone replacement therapy medication has the potential for creating life-threatening heart and blood vessel problems in those who use the products. The Canadian regulatory agency said it is working with testosterone drug manufacturers to update their product labels to reflect the risk of heart attack, stroke, blood clots in the lungs or legs and increased or irregular heart rate associated with using the prescription medication. According to Health Canada, there are 12 testosterone-containing products currently marketed for use in Canada that includes Andriol, Androderm, AndroGel, Axiron, Delatestryl, Depo-Testosterone, Testim and their equivalent generics.
[healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/40587a-eng.php, July 15, 2014]
The FDA announced in January that it was re-evaluating all FDA-approved prescription testosterone replacement drugs based on two studies that showed men who take testosterone replacement therapy are at a higher risk for strokes, heart attacks and death. The first publication the FDA noted was an observational study published in the November 2013 Journal of the American Medical Association. The men included in this study had low serum testosterone and were undergoing imaging of the blood vessels of the heart to assess for coronary artery disease. Some of the men received testosterone treatment while others did not. Many of the men had an underlying cardiovascular disease. This study suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy. The second study published in the PLOS One Journal on January 29, 2014, reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy. In addition to these studies, the FDA said it will use other available information before announcing its final conclusions and recommendations about low testosterone products.
[fda.gov/Drugs/DrugSafety/ucm383904.htm?utm_source=rss&utm_medium=rss&utm_campaign=fda-evaluating-risk-of-stroke-heart-attack-and-death-with-fda-approved-testosterone-products, January 31, 2014]
[plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805, January 29, 2014]
[jama.jamanetwork.com/article.aspx?articleid=1764051, November 6, 2013]
In a related matter, the FDA in June ordered manufacturers of all FDA-approved testosterone products to include a general warning on their drug labels about the risk of the testosterone prescription medication causing blood clots in veins of users. The testosterone drug labels currently have a warning about venous blood clots forming as a consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occur with testosterone replacement therapy. The FDA, however, said that post-market reports have shown that venous blood clots are occurring that are unrelated to polycythemia. [fda.gov/drugs/drugsafety/ucm401746.htm, June 19, 2014]
Wright & Schulte LLC attorneys are representing plaintiffs in federal multidistrict litigation underway in the U.S. District Court, Northern District of Illinois. In June, a panel of federal judges created an industrywide consolidation of all testosterone lawsuits filed in federal courts across the country on behalf of men who allege that they suffered strokes, heart attacks and death as a result of taking prescribed low testosterone medication. (In Re: Testosterone Products Liability Litigation, No. 42, JPML) The lawsuits name the makers of such testosterone drugs as AndroGel, Androderm, Axiron, and Testim as defendants. In one lawsuit, Wright & Schulte LLC is representing a Lafayette, Louisiana, man who took Depo-Testosterone injections between 2012 and 2014, that allegedly caused him to experience physical impairments, including anxiety, increased hypertension and an elevated heart rate. The complaint names Pfizer, Inc. and Pharmacia & Upjohn Co., the manufacturers of the testosterone drug, as defendants.
About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free low testosterone lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.
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