Large-Scale Studies Necessary to Examine Testosterone Therapy Risks

Side Effects of Testosterone Therapy

Written by Faith Anderson on February 13, 2014
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Large-Scale Studies Necessary to Examine Testosterone Therapy Risks

Experts are calling for additional research to study the risk of cardiovascular events among men using testosterone treatments.

In light of new information about the potential side effects of testosterone therapy, a group of experts are calling for a large-scale scientific study to aid doctors in understanding the risk of heart attack, stroke and other injuries that may be caused by AndroGel, AndroDerm, Testim, and other blockbuster testosterone replacement treatments. On February 7, the Endocrine Society issued a statement warning about the findings of two recent studies, which indicate that testosterone therapy may put patients at risk for life-threatening cardiovascular side effects, including heart attack and stroke. If you believe you have suffered injuries from testosterone treatment, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a qualified lawyer who has experience handling testosterone therapy cases.

FDA Investigates Testosterone Therapy Risks

On January 31, the FDA announced its decision to investigate the possible risks of testosterone replacement therapy, indicating that the products were never approved for any use other than to treat men suffering from hypogonadism, a medical condition causing them to have lower testosterone levels than normal. However, many men are being prescribed testosterone treatments like AndroGel off-label, for symptoms like fatigue and decreased sexual virility, which are normal signs of aging, to help reverse the natural decline of testosterone. New research indicates that this could put men at risk for serious and possibly even life-threatening side effects.

Studies Highlighting Side Effects of Testosterone Drugs

According to a study published in November 2013, side effects of testosterone drugs were associated with an increased risk of stroke, heart attack and death among older men with certain pre-existing heart conditions. Another study published in January 2014 found that testosterone replacement therapy may double the risk of heart attack side effects for younger men with heart disease and men over the age of 65, regardless of the condition of their heart. In light of these potential risks, many consumers are questioning why the makers of these testosterone medications have not already been required to conduct large-scale randomized trials to determine the safety of their products.

Testosterone Therapy Lawsuits Over Heart Attack, Stroke

A growing number of men who suffered strokes or heart attacks in recent years are now considering testosterone therapy lawsuits, alleging that they could have avoided serious medical problems if they had been informed of the risks associated with AndroGel and similar treatments. While these men are just now learning about the link between testosterone therapy and heart problems, critics argue that manufacturers knew or should have known about the risk and conducted additional studies. In 2009, research involving more than 200 older, frail men was halted early after researchers found that those receiving testosterone treatments experienced a spike in heart attacks. If you have suffered a heart attack or stroke and you believe testosterone therapy to be the cause, contact a product liability attorney today to discuss your legal options.

[box type=”note” align=”aligncenter” ]Source: https://www.endocrine.org/~/media/endosociety/Files/Advocacy%20and%20Outreach/Position%20Statements/Other%20Statements/The%20Risk%20of%20Cardiovascular%20Events%20in%20Men%20Receiving%20Testosterone%20Therapy.pdf[/box]

Posted Under: FDA - Food and Drug Administration, News, Testosterone Replacement Therapy
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