FDA Advisory Committee Holds Hearing on Testosterone Safety

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TRT Litigation Subcommittee, Including Zoll, Kranz & Borgess Attorneys Michelle L. Kranz and James G. O’Brien, Advocates for Stronger Testosterone Warnings Before FDA Committee

Zoll, Kranz & Borgess, LLC

The Food and Drug Administration (FDA) has scheduled a hearing for today, September 17, 2014, to consider:

1. The appropriate indicated population for Testosterone Replacement Therapy (TRT), and
2. The potential for adverse cardiovascular outcomes associated with use of TRT.

With the TRT litigation ongoing, an informally-organized litigation group subcommittee prepared a presentation for the FDA on the dangers of testosterone replacement therapy. Among others, ZKB attorney Michelle L. Kranz and ZKB attorney James G. O’Brien contributed to the group’s position that the TRT manufacturers are over-promoting their drugs as lifestyle enhancements and not warning patients of the serious cardiac risks.

Several victims of testosterone therapy are scheduled to testify about how TRT makers such as Abbott / AbbVie (maker of AndroGel) and other manufacturers over-promoted and over marketed their products without explaining that they carry risks of heart attack, stroke, deep vein thrombosis, and even death. Some of the victims will share stories of the devastating health effects that resulted.

The manufacturers are expected to defend their safety records and their decisions not to put stronger warnings on their products in an attempt to convince the FDA not to restrict their marketing.

An FDA Committee recommendation may take months to determine whether TRT products should have stronger warnings about cardiac events and whether the companies are properly marketing to the indicated population.

The FDA Advisory Committee Regarding TRT information can be found through the link provided. You can also read more about the litigation and the involvement Zoll, Kranz & Borgess has in the MDL on our website. We welcome your questions, please contact our Testosterone Lawsuit Team toll-free at 888-841-9623.

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James G. O'Brien, Esq.
since: 08/2011
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Zoll, Kranz & Borgess, LLC
since: 07/2011
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Zoll, Kranz & Borgess, LLC

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