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FDA Requires New Labeling Change for Testosterone Drugs Regarding Increased Risk of Heart Attack and Stroke

On March 3, 2015, the Food and Drug Administration (FDA) issued a Safety Announcement cautioning that testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions, rather than due to aging. The FDA also required manufacturers of testosterone drugs to clarify the approved uses of these medications and […]

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EMA Agrees with FDA: Testosterone Therapy Drugs Not for Lifestyle Use

According to a recent report, the EMA has agreed with the FDA that the use of testosterone drugs should be reserved for men whose testosterone levels are low due to a medical condition. An EMA oversight committee said, “Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older mean is […]

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Testosterone Therapy (Low-T) Lawsuit Update: Direct Filing Order Entered in MDL 2545

On October 24, 2014, The Honorable Matthew F. Kennelly entered an Order allowing for the filing of federal complaints directly into the testosterone therapy multidistrict litigation (MDL 2545) pending in the United States District Court for the Northern District of Illinois. Kristine Kraft, a partner at Schlichter, Bogard & Denton, LLP, has been appointed by […]

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FDA May Tighten Restrictions for Testosterone Drugs

CBS reports that the FDA Advisory Committee voted 20-1 that the product labels of popular testosterone drugs should be revised to clearly indicate that these drugs have not been shown to reverse common aging issues, including muscle loss and libido. Members of the Advisory Committee also unanimously agreed that evidence linking cardiovascular events and blood […]

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Testosterone Lawsuit Update: FDA Advisory Committee Decides Further Study of Cardiovascular Risks Required

Bloomberg News reports that the members of a Food and Drug Administration (FDA) Advisory Committee unanimously agreed this week that manufacturers of testosterone drugs should further study the potential cardiovascular health risks of testosterone products and who should take these drugs. According to the FDA, the Advisory Committee Meeting was held on September 17, 2014 […]

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FDA Warns of Dangerous Testosterone Risks for Men, NBC News Reports

NBC Nightly News reports that “[t]estosterone treatment is a growing multibillion-dollar business, but it presents the risk of life-threatening blood clots.” In the news segment, the NBC reporter comments: “In 2013, doctors wrote 7.5 million prescriptions for testosterone, up from about 4 million in 2009. While treatment for abnormally low testosterone levels is warranted in […]

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Schlichter, Bogard & Denton, LLP News: Partner Kristine Kraft Appointed to the Plaintiffs’ Steering Committee in Testosterone Therapy MDL 2545

Kristine Kraft, a partner at Schlichter, Bogard & Denton, LLP, has been appointed to the Plaintiffs’ Steering Committee in the Low-T Multidistrict Litigation (MDL 2545) pending in the Northern District of Illinois (Case Management Order No. 4, In Re: Testosterone Therapy Products Liability Litigation, Case No. 1:14-cv-1748, MDL No. 2545, N.D. Ill.). The Honorable Matthew […]

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Low-Testosterone Replacement Therapies Make Cover of Time Magazine: Are They Safe?

The topic of low testosterone (Low-T) replacement therapy drugs will be discussed, along with securing the coveted cover page, in the August 2014 issue of Time Magazine. The magazine will feature an article discussing the $2 Billion testosterone drug industry and detailing the safety concerns centered around Low-T replacement medications. This comes as no surprise […]

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Health Canada Warns of Cardiovascular Risks Associated with Testosterone Therapy Drugs

On July 15, 2014, Health Canada warned patients and healthcare professionals of serious and possibly life-threatening cardiovascular risks associated with testosterone replacement therapies. Health Canada recently completed a safety review of low-testosterone products, which revealed that Low-T product use is linked to heart and blood vessel problems, such as heart attack, stroke, pulmonary embolisms (blood […]

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Low-T Lawsuit Update (MDL 2545): FDA Weighs Data on Testosterone Drugs and Heart Attack Risk

The U.S. Food and Drug Administration (FDA) has called a special advisory committee meeting to discuss the results of two trials that demonstrated an increased risk of heart attack in men using testosterone replacement drugs. The FDA called the meeting after it required new label changes on all testosterone replacement therapies to warn consumers of […]

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