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FDA Updates AndroGel Risks to Include Blood Clots In Legs and Lungs as Testosterone Treatment Lawsuits Move Forward

Columbus, OH (PRWEB) July 26, 2014

The U.S. Food & Drug Administration (FDA) has released an updated medical guidelines list that includes a new medication guide for AndroGel to include blood clots in the legs and lungs as a serious side-effect of taking the topical low testosterone medication, notes Wright & Schulte LLC. The firm also notes that AbbVie Inc., the makers of the low testosterone theapy drug, has also updated the official AndroGel website to include symptoms of pain, swelling or redness as signs of a blood clot in the leg and difficulty breathing or chest pain as signs of a blood clot in the lung. As the FDA makes label changes regarding blood clots, they also continue to investigate the potential cardiac risks associated with testosterone products such as Adrogel as lawsuits are being filed under an industry-wide testosterone lawsuit consolidation pending in the U.S. District Court, Northern District of Illinois. As of July 15, 2014 there have been 156 testosterone treatment lawsuits pending litigation that have been filed on behalf of men who allege that they suffered from heart attack, stroke, pulmonary embolism, deep vein thrombosis and other serious side-effects from using AndroGel and other testosterone therapy drugs. (In re: Testosterone Replacement Therapy Product Liability Litigation – MDL No. 2545)
[, June 27, 2014]

The attorneys at Wright & Schulte continually speak with men who believe they have suffered side-effects from testosterone treatment drugs such as AndroGel and urge those who have experienced blood clots in their legs or lungs, or cardiac events such as strokes and heart attacked after taking testosterone treatment medications to contact one of their attorneys at 1-800-399-0795 or visit

According to the FDA, a medication guide is a paper hand-out that comes with prescription medications. The guide addresses specific issues about the medication and contains FDA-approved information to help patients avoid serious adverse events from taking the particular medication. With the addition of the FDA-ordered content for AndroGel, the testosterone treatment medication guide for AndroGel now has seven specific side-effects that include:

  • Enlargement of the prostate gland
  • Possible increased risk of prostate cancer
  • Lower sperm count if taken in large doses
  • Swelling in ankles, feet or body, with or without heart failure
  • Enlarged or painful breasts
  • Sleep apnea
  • Blood clots in the legs or lungs

Testosterone products, such as AndroGel, Androderm, Axiron, Delatestryl, Depo-Testosterone, and Testim have been under scrutiny by the FDA, which recently called for a meeting in September of two of its advisory panels to discuss the potential for testosterone replacement therapy drugs to cause heart attacks in men who use the medication. In January, the FDA announced it was launching an investigation into all FDA-approved prescription testosterone replacement medications based on two observational studies that showed men who use testosterone products to treat hypogonadism (low testosterone) are at a higher risk for strokes, heart attacks and death. An observational study published in the November 2013 by the Journal of the American Medical Association (JAMA) compared men who were being assessed for coronary artery disease. Some of the men were prescribed low testosterone medication while others were not. The study suggested a 30 percent increased risk of stroke, heart attack, and death in the men that had been prescribed testosterone replacement medication. Another study published January 29, 2014, in the PLOS One Journal found an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy.
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[, January 31, 2014]
[, January 29, 2014]
[, November 6, 2013]

Court documents indicate that the manufacturers of testosterone products, including Abbot Laboratories Inc. and AbbVie, Inc., have been named as defendants in numerous testosterone treatment lawsuits. Earlier this year, plaintiffs in AndroGel lawsuits asked a panel of federal judges to consolidate all AndroGel lawsuits in the federal district court in Northern Illinois. In June, the judicial panel instead consolidated all testosterone lawsuits, regardless of their name brand and manufacturer, for pretrial proceedings in the Northern Illinois federal court. Prior to the consolidation, an AndroGel lawsuit was filed by a Louisiana man who alleges that he was prescribed the low testosterone medication in September 2011 for symptoms he attributed to low testosterone after viewing the advertisement of AbbVie Inc. for AndroGel. According to the AndroGel complaint, the man continued using the medication until January 2013 and in February 2013, he had a stroke. (Case No. 2:14-cv-00935)

About Wright & Schulte LLC
Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free low testosterone lawsuit case evaluations are available through or by calling 1-800-399-0795.

Wright & Schulte LLC
812 East National Road
Vandalia, Ohio 45377
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