Tuesday, April 01, 2014

4/1/14: Georgia Androgel, Low Testosterone Litigation: Attorneys Petition for MDL Status

Late Friday lawyers for several parties filed a Petition in the JPML seeking centralization of all cases involving low testosterone claimed injuries:




Abbot and AbbVie filed a Reponse, here:

 


A  study was funded by  National Institutes of Health and published in the journal of PLOS ONE. The study evaluated more than 50,000 men and indicated that prescription Testosterone Therapy (also commonly known as Low T Treatment) significantly increased the risk of heart attacks in men over the age of 65 and, in younger men with a history of heart disease.

The study concluded that the risk of heart attacks in the first three months of testosterone therapy is doubled in men over age 65 with no prior heart conditions and the risk of heart attack in men below 65 with a history of heart disease is almost tripled.


Currently, the labels of these products that are being used by tens of millions of American men contain no warning an increased risk of cardiac or cardiovascular events. On January 30, 2014, after the release of these two studies, the FDA issued a "Drug Safety Communication" announcing it is reassessing the safety of these products and continuing to evaluate available data regarding an increased risk of cardiovascular events.


Testosterone Therapy can come in several forms, such as: gels, patches, under arm topical solutions, pellets, and injections, and include the following brands:
  • Androgel®
  • Axiron®
  • Fortesta®
  • Testim®
  • Testopel®
  • Androderm®
  • Depo-Testosterone®
  • Striant®
  • Bio-T-Gel®
  • Delatestryl®