FDA Requires Testosterone Medication Manufacturers to Add Expanded Blood Clot Risk to Warning Labels, Baron and Budd Reports

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Required Change Reflects Reports of Additional Clotting Not Related to Condition Covered by Current Warnings

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The U.S. Food & Drug Administration (FDA) has ordered testosterone therapy drug makers to provide additional warnings in regard to blood clots to those already in place, the national law firm of Baron and Budd reports. This development occurs as federal litigation involving testosterone treatment lawsuits proceed in the U.S. District Court, Northern District of Illinois. (In Re: Testosterone Products Liability Litigation, MDL No. 2545.)

Currently, testosterone medication manufacturers warn patients of a condition known as polycythemia. Polycythemia is a condition in which the proportion of blood volume that is occupied by red blood cells increases; either through an in the size and number of red blood cells or a decrease in the volume of plasma. This increase in blood volume can lead to blood clots due to more red blood cells in the veins. Polycythemia has been linked to the use of testosterone medications. However, the FDA is now directing drug makers to change the labeling due to increased reports that other kinds of clotting, those not linked to polycythemia, have occurred in testosterone therapy patients. (fda.gov/Drugs/DrugSafety/ucm401746.htm, June 19, 2014)

The FDA’s new warning requirement on testosterone manufacturers will require them to add a general warning to the labeling about the risk of developing blood clots in the veins. These clots, also known as venous thromboembolism (VTE), include potentially life threatening conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE).

There are more than 100 testosterone therapy lawsuits in the U.S. District Court of Illinois filed by plaintiffs who allege the medication resulted in strokes, heart attacks, blood clots and fatalities in patients using the drugs. On January 31, 2014, the FDA released an announcement that it was performing a review of testosterone therapy medications after studies showed men taking the drugs were at a higher risk of suffering cardiovascular problems. (http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm)

On June 6, 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) issued a Transfer Order that created an MDL to consolidate lawsuits so that the cases can progress more quickly, reduce the expenses associated with these types of claims, and ensure that there are uniform rulings in regards to evidence and other matters. Plaintiffs, according to the Order, predict that there could eventually be thousands of lawsuits associated with adverse health effects linked to testosterone therapy drugs. (http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2545-Initial_Transfer-05-14.pdf)

“This additional warning issued by the FDA is disturbing because it highlights a potential additional risk that was not previously disclosed by the manufacturers,” said Stephen Blackburn, lawyer at the national law firm Baron and Budd. “This strengthens our resolve to work to protect the rights of those who have been adversely affected by these drugs.”

The national law firm of Baron and Budd may be able to help if you or a family member has suffered health problems after using testosterone therapy drugs. Call 1-866-472-9108 or visit our website at http://baronandbudd.com/areas-of-practice/pharmaceuticals/testosterone-therapy/ to learn what legal options you may be able to pursue.


The law firm of Baron and Budd, with offices in Dallas, Baton Rouge, Austin and Los Angeles, is a nationally recognized law firm with over 35 years of “Protecting What’s Right” for people, communities and businesses harmed by negligence. Baron and Budd’s size and resources enable the firm to take on large and complex cases. The firm represents individuals, governmental and business entities in areas as diverse as water contamination, Gulf oil spill, Qui Tam, California Proposition 65 violations, unsafe drugs and medical devices, Chinese drywall, deceptive advertising, consumer financial fraud, securities fraud and asbestos cancers such as mesothelioma.

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Amanda Billo
Baron & Budd
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