Testosterone Therapy

Endocrinology Groups Echo FDA Call for More Research on Testosterone Therapy Risks

endocrinologist group calls for testosterone therapy researchThe American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) recently issued a joint position statement on the cardiovascular risks of testosterone therapy. In the statement, the two endocrinology groups questioned the FDA’s recommended method for determining whether a patient requires testosterone therapy and call for more research on the health risks posed by Low-T products.

The FDA has indicated that testosterone therapy is ...

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AbbVie Unhappy with Testosterone MDL Bellwether Trial Selection

abbvie not happy with bellwether trail selectionAbbVie, maker of the popular testosterone therapy product AndroGel, has expressed dissatisfaction with the federal court’s bellwether trial selection process, Forbes reports. The U.S. District Court for the Northern District of Illinois has chosen AbbVie to defend in the first MDL testosterone lawsuit to go to trial. AbbVie, a defendant in the fast-growing Illinois testosterone therapy MDL, has been instructed to select 32 potential cases to be prepared for ...

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Testosterone Therapy Lawsuits Not Letting Up as South Carolina Claim Joins MDL

more testosterone therapy lawsuits join multidistrict litigationThe most recent report from the U.S. Judicial Panel on Multidistrict Litigation shows 2,231 testosterone lawsuits included in the Illinois MDL —and there’s no sign that the flood of lawsuits will let up any time soon. According to the Public Access to Court Electronic Records (PACER) database, over 40 new testosterone lawsuits were filed in the last week alone. A testosterone lawsuit filed last month by a ...

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New Testosterone Study Shows Mixed Results

Another pharma-funded testosterone therapy study has been published, this time in the Journal of the American Medical Association. The authors, two of whom worked with or profited from big-name testosterone therapy manufacturers, found that men who took testosterone did not show any significant difference in risk of atherosclerosis; at the same time, the study also revealed these men experienced no sexual or health-related improvement in quality of life. As noted by ...

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FDA Not Convinced about Testosterone Therapy Safety

fda not satisfied with testosterone therapy safetyThe U.S. Food and Drug Administration (FDA) recently informed “Low-T” drug manufacturers they will need to do a better job of demonstrating their products’ safety if they wish to market them to aging men. The agency’s argument was laid out by Christine P. Nguyen, a Deputy Director for Safety at the FDA, in an article in the New England Journal of Medicine.

Earlier this year, the ...

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New Study Unable to Show Testosterone Does Not Increase CV Risk

controversial study claims no cardiovascular risk with testosterone therapyA new study published in the Mayo Clinic Proceedings purports to show that testosterone therapy does not increase the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE), though the validity of these results may be questionable.

Testosterone therapy products are intended to regulate hormone levels in men with medically confirmed low testosterone. (The drugs are not approved for use in men experiencing the natural ...

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