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FDA Requires Makers of Testosterone Therapy to Include Warnings

 Posted on June 29, 2014 in Drugs

In June, the Food and Drug Administration (FDA) issued a statement requiring drug-makers who manufacture testosterone to issue a warning label on the drug regarding the potential risk for venous blood clots.

Testosterone replacement drugs are a medicinal therapy for men with erectile dysfunction, though according to WebMD, “inadequate production of testosterone is not a common cause of ED.”

The natural decline of testosterone in a man's body begins after age 30, but there are several causes of lack of testosterone production. Reasons for inadequate testosterone production include (but are not limited to):

  • Injury or infection of the testes;
  • Genetic abnormalities;
  • Chronic illness or kidney failure;
  • Liver cirrhosis;
  • Alcoholism;
  • Inflammatory diseases;
  • Chemotherapy or radiation; and
  • Obesity.

According to Healthline News, the FDA first published research that testosterone therapy could cause increased risk of heart problems in February of this year. Two independent studies linked such drugs to heart problems, which caused the FDA to reassess their previous analysis that the drugs were entirely safe.

The later study, according to Healthline, was published in PLOS ONE and reported that men over the age of 65 were found to have increased heart problems after 90 days of the therapy, while the chance of younger men having a heart attack within the same time period increased two or three-fold. The second study, published in the New England Journal of Medicine in 2010, found that the hormone therapy, when taken by men 65 and older, resulted in skin, cardiac, and respiratory problems.

Both of these studies contributed to the requirement that all makes of such hormone therapies now label their products with a warning, as reported by Drugwatch.com, though it was the PLOS ONE study (released in January) that really spurred the FDA to action.

If you or someone you know in Illinois has experienced heart problems due to testosterone therapy and were not made aware of the risks before beginning the medication, you may be eligible for compensation. Do not go through it alone. Contact Newland & Newland, LLP today.

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