If you, a friend or a loved one has suffered an injury associated with taking testosterone therapy, please contact the Law Offices of John David Hart at 800-247-1623 or johnhart@hartlaw.com to discuss your legal rights. In recent months, there has been an increasing amount of evidence indicating that testosterone therapy may cause serious and permanent injuries resulting from heart attack and strokes in patients.
Summary
On January 31, 2014, the U.S. Food and Drug Administration (FDA) issued a safety alert indicating the agency will investigate whether an association exists between the use of FDA-approved testosterone products and the increased risk of stroke, heart attack and death in men. The FDA chose to issue this safety alert following the recent publication of two scientific articles, one from the Journal of the American Medical Association (JAMA) and the other from PLoS ONE, that found an association between the use of testosterone products and the increased risk of serious health concerns, such as stroke and heart attack. While the FDA is not formally advocating that patients stop using testosterone products, the agency is encouraging patients and health professionals to report any adverse side effects associated with the use of testosterone products.
FDA approval of testosterone products
The FDA has approved testosterone products only for use in men who have low to no testosterone levels in combination with a related medical condition. Examples of these types of associated conditions include disorders of brain structures that control the testicles’ production of testosterone and inability of the testicles to produce any testosterone.
According to the FDA’s safety alert, none of the testosterone products that have been approved by the agency are permitted for use in men who do not have an associated condition in conjunction with low testosterone levels. Examples of FDA-approved testosterone products include transdermal patches, topical gels, buccal systems, and injections.
Testim and Fortesta are commonly prescribed testosterone products sold in the U.S. (images from NIH website)
Recent scientific findings of adverse health risks associated with testosterone products
Two recent scholarly articles have released alarming findings on the possible association between use of testosterone products and the increased risk of heart attack and stroke in men taking these drugs. The first article, published in November 2013 by the Journal of the American Medical Association (JAMA) published the results of a study that assessed a group of men across the country with low testosterone levels who underwent heart tests, such as coronary angiographies, between 2005 and 2011. The results of the study indicated there is an association between the use of testosterone therapy and an increase in adverse health risks, specifically heart attack and stroke. Perhaps more alarming, this association was found amongst patients with and without coronary artery disease (CAD). The researchers themselves stated that “these findings raise concerns about the potential safety of testosterone therapy.”
The second article, published in January 2014 by PLoS ONE, provided results of a recent study that found that in “older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI [myocardial infarction] following initiation of [testosterone therapy] prescription is substantially increased.” In younger men, 65 years old and younger, with a history of heart disease, it was determined that there was a two to three-fold increased risk of heart attack in the 90 days following the initial testosterone therapy prescription. The study did not find any excess risk in younger men that did not have a history of heart disease.
FDA recommendations
While the FDA has issued this safety alert indicating it will further investigate testosterone products, the agency has not yet reached conclusions regarding an association between these types of drugs and the increased risk of heart attack and stroke. The agency encourages patients to first speak with their health care providers prior to stopping the use of testosterone products. Furthermore, the FDA encourages health care professionals to evaluate whether the possible benefits of prescribing testosterone treatments outweigh the serious potential risks that may be associated with the same.
If you or a loved one has experienced a heart attack, stroke or death while taking testosterone therapy, contact the Law Offices of John David Hart at 800-247-1623 or johnhart@hartlaw.com to discuss your legal rights. We are experienced in helping individuals and families deal with the devastating effects of dangerous drugs and are dedicated to helping you during this difficult time.
Read more about the health risks associated with testosterone products
Read frequently asked questions regarding testosterone products
