FDA Issues New Warning For Low T Products

The U.S. Food and Drug Administration last week announced it is requiring testosterone drug manufacturers to include a wider warning about the increased risk of blood clots in the veins.

The FDA previously had warned that such clots could occur in certain patients who developed an abnormal increase in the number of red blood cells, a condition called polycythemia, but the agency has recently received numerous reports of such clots occurring in those who are not afflicted with this complication. Blood clots in the veins include deep vein thrombosis (DVT) and pulmonary embolism, a potentially life-threatening event that occurs when a clot travels to the lungs.

Testosterone products are approved for use in men who have low levels of the hormone due to medical conditions such as testicular failure, previous use of chemotherapy, or a problem with the pituitary gland. Men with low testosterone levels may have symptoms such as low sex drive, depression, fatigue and muscle weakness.

Earlier this year, the FDA announced that it was reviewing the latest research to determine whether these “Low T” products posed an unacceptable increase in the risk of strokes, heart attacks, and death in men who used them. The new warning is not related to this ongoing investigation.

Testosterone therapy products have been heavily advertised on television and other medium. Products on the market or about to be launched include AbbVie Inc's AndroGel, Endo International Plc's Aveed and Trimel Pharmaceuticals Corp's Natesto. Therapy is typically given in gel, patch or injection form. It has been reported that sales of AndroGel exceeded sales of Viagra in 2013.

"Low T" litigation has been consolidated into an MDL in the Northern District of Illinois.

Pittman, Dutton & Hellums, P.C. is currently investigating Low T Therapy claims. If you or a loved one were prescribed testosterone therapy and were injured as a result, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com.

Low T Cases Consolidated Into MDL

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered all product liability lawsuits filed in U.S. District Courts nationwide involving injuries associated with the use of any testosterone replacement therapy (TRT) to be centralized before one judge in the Northern District of Illinois as part of an MDL, or multidistrict litigation.

Following oral arguments late last month in Dallas, Texas, the JPML issued an order on June 6, which transfers cases involving any “Low T” drugs to U.S. District Judge Matthew F. Kennelly for coordinated handling during pretrial proceedings.

Testosterone is a hormone that promotes the growth of the male reproductive system, contributes to proper sexual function, boosts libido, prevents loss of scalp hair and can reduce the accumulation of abdominal fat.Treatment is often prescribed to men in order to counteract the age-related decline in the hormone. It helps improve sex drive, bone density and muscle mass. But the benefits and risks of the long-term use of testosterone therapy are not well known. Testosterone therapy is most often administered as a gel, patch or injection.

There are approximately 45 filed Low T lawsuits in Federal districts throughout the country. Major side effects claimed in these lawsuits include stroke, heart attack or even death. Use of the medication has been linked to certain other risks, including heart problems, sleep apnea, high red blood cell production, skin reactions, breast enlargement and lower sperm production.

The following products treat low testosterone:

• Androgel
• Androderm
• Axirom
• Bio-T-Gel
• Delatestryl
• Depo-Testosterone
• Fortesta
• Striant
• Testim
• Testopel

The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. It has been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.

Pittman, Dutton & Hellums, P.C., is currently investigating Low T Therapy claims. If you or a loved one were prescribed testosterone therapy and were injured as a result, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com.