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Testosterone is an important hormone. It causes men to develop male characteristics, such as deeper voice, larger muscle mass and facial hair.
As men get older, they often produce less testosterone.
Most of the time, this occurs naturally. Sometimes, men lose testosterone because of illness or using drugs that affect the pituitary gland.
Having low testosterone (Low T) can lead to a decrease in sex drive, reduced bone density, less energy and loss of muscle mass.
Millions of men use testosterone replacement therapy to try and restore this hormone. Common Low T treatments include:
Although advertised as a way to restore your sex drive and improve your vitality, Low T treatments can also increase the likelihood that you will have a venous thromboembolic event including deep vein thrombosis (DVT) or pulmonary embolism (PE), heart attack or stroke, or die.
The U.S. Food and Drug Administration (FDA) has issued an alert about Low T treatments. The FDA is currently evaluating the risks of heart attack, stroke and death users of testosterone therapy face.
On June 19, 2014, the FDA required testosterone manufacturers to include additional warnings in their drug labels regarding the risk of venous blood clots including DVT and PE.
In September 2014, two FDA Advisory Committees met jointly to discuss the suspected link between testosterone and cardiovascular risks, including stroke, heart attack and death. They also voiced near-unanimous opposition to allowing new oral testosterone products to enter the market.
The panel expressed opposition to off-label uses of testosterone products in general and called for more stringent label indications, and additional labeling language regarding testosterone product safety and efficacy. Additionally, the panel voted in favor of requiring testosterone manufacturers to investigate the cardiovascular risks by undertaking additional clinical trials of their products.
In March 2015, the FDA issued a Drug Safety Communication recognizing that there is a possible increased cardiovascular risk associated with testosterone use in men. Some studies reported that men may have an increased risk of stroke, heart attack or death associated with testosterone treatments. The FDA is requiring changes to the labels for all prescribed testosterone products to reflect this possibly increased risk.
The FDA also cautioned consumers that prescription testosterone products only are approved for men who have low testosterone levels caused by certain medical conditions, and that the benefit and safety of testosterone use in men who do not have such conditions have not been established. The FDA is requiring prescription testosterone manufacturers to change their labeling to clarify the approved uses of prescription testosterone medications.
If you have used a Low T treatment and experienced a heart attack or had a stroke, consider reaching out to an attorney to see if you deserve compensation. You may also have a potential lawsuit if a loved one used these products and died.
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