Scheduling of Advisory Committee Hearing Comes as Scores of Men Pursue Testosterone Lawsuits That Allege Use of Low Testosterone Therapy Caused Heart Attacks, Strokes, Blood Clots and Other Cardiovascular Problems.
Testosterone Lawsuit News: The testosterone lawsuit attorneys at The Oliver Law Group P.C. were pleased with the recent announcement that the U.S. Food & Drug Administration (FDA) had scheduled an advisory panel meeting to examine the cardiovascular risks associated with low testosterone therapy. According to a report from Reuters, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet in a joint session on September 17, 2014 to discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes.
(reuters.com/article/2014/07/17/us-fda-drugsafety-idUSKBN0FM2G320140717, Reuters, July 17, 2014)
Interested individuals may present data, information, or views, orally or in writing, on issues pending before the committee, according to the FDA. Submissions must be made on or before September 3, 2014. Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m. on September 17th.
(Fda.gov/AdvisoryCommittees/Calendar/ucm404905.htm, FDA, July 17, 2014)
Testosterone medications such as AndroGel, Testim and Axiron are used to treat men who suffer from hypogonadism, or low testosterone. According to court documents, 156 testosterone lawsuits are now pending in Illinois federal court, all of which allege the use of low testosterone therapy increases the risk that some men will suffer adverse cardiovascular events, including heart attacks, strokes, deep vein thrombosis, pulmonary embolism, congestive heart failure and death. (In re: Testosterone Replacement Therapy Product Liability Litigation – MDL No. 2545)
The testosterone litigation has been growing since January, after the FDA revealed was investigating a possible increased risk of heart attack, stroke and death among men who receive testosterone treatment. That review was launched after several studies suggested testosterone medications could increase cardiovascular risks in certain men.
(fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm384225.htm, FDA, January 31, 2014)
Just last month, the FDA announced that it was requiring the manufacturers of low testosterone products to add new information to the drug’s labels regarding an association with potentially-dangerous venous blood clots, including deep vein thrombosis and pulmonary embolism. According to the June 20th notice, the new blood clot warning refers to venous clots that are not related to polycythemia, a dangerous elevation of red blood cells sometimes seen in men taking low testosterone drugs. That potential side effect was already listed on the medication’s labels.
(fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm402054.htm, FDA, June 20, 2014)
The Oliver Law Group is offering free low testosterone lawsuit reviews to men who allegedly suffered heart attacks, strokes or other cardiovascular events due to testosterone replacement drugs. Free legal evaluations are also being offered to families of men who allegedly died as result of a testosterone-related heart event. To learn more about filing a testosterone therapy lawsuit, please contact our office by calling 800-939-7878 today.
About The Oliver Law Group P.C. and filing a testosterone lawsuit
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If you would like to learn more about filing a testosterone lawsuit, turn to the law firm with the Experience, Dedication, and Trust you deserve. Contact the Oliver Law Group P.C. for your free case review by calling toll free 800-939-7878 today.