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Lawsuits Filed Days After FDA Announces Investigation Into Testosterone Therapy Treatment

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On February 4, 2014, five lawsuits were filed in Illinois federal court against AbbVie Inc., and Abbott Laboratories, Inc., the manufacturers of Androgel, a testosterone therapy treatment.  This Androgel lawsuit comes just days after the U.S. Food and Drug Administration (FDA) announced that it is investigating the risk of heart attack, stroke and death in men taking testosterone products.

Plaintiff Claims Manufacturers Misled Consumers

One plaintiff, Kenneth Aurecchia, filed his case (1:14-cv-772) through the United States District Court for the Northern District of Illinois Eastern Division, seeking relief to treat and monitor severe side effects caused by Androgel.  Aurecchia claims he was prescribed Androgel for what he thought were symptoms of low testosterone after watching commercials for the product.

He alleges the manufacturers concealed facts about the serious side effects associated with the drug.  He also claims he went through physical and emotional damage including suffering from a heart attack.

Testosterone Therapy Treatment & Heart Attack Risk

On January 31st, 2014, the FDA announced plans to review the risk of a heart attack among men taking a form of testosterone therapy. This investigation was prompted by two recent studies, including one published in PLOS One. It found that men aged 65 and older were twice as likely to suffer from a heart attack after filling a testosterone therapy prescription.  It also found that younger men had three times the risk if they had a family history of heart disease.  There was no additional risk found in younger men without that type of medical history.

Testosterone is a male hormone that helps preserve a male’s strength, bone density, sex drive, red blood cell production, production of sperm and fat distribution.

Androgel is a topical hormone gel for men.  It’s available in two forms: Androgel 1%, and Androgel 1.62%.  The drug is used to treat men with low or no testosterone due to age or hypogonadism, which is a disease where the body doesn’t produce certain amounts of testosterone due to problem with the pituitary gland or testicles.  The makers of Androgel say the product produces the same testosterone your body makes on its own.

Other Potential Risks

In addition to the potential for a heart attack, risk or stroke, the FDA ordered the makers of Androgel to issue a black box warning in 2009 for “secondary exposure.”  Children and women were experiencing adverse effects when they came into contact with the gel.  These included early signs of puberty in children and excess hair growth, and acne in women.

The FDA has not “concluded” that this type of treatment leads to heart attacks, strokes or death.  You should report side effects to your doctor and to the “FDA MedWatch program.”  This is the first one of what is expected to be many testosterone therapy treatment lawsuits filed in U.S. Courts.

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  1. Kirk Yager says:
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    Umm, seems to me that someone doesn’t know how to read the package insert. Fully describes the possible risks.

    The issue isn’t the drug (testosterone). It’s the incompetent physician’s that have the authority to prescribe, and minimal training on how too monitor male hormones, and or screen patients for clotting disorders.

    Sitting too long can cause thrombosis, does this mean we can sue a chair manufacture?