A number of recently releases studies, as well as an FDA issued Safety Announcement on the use of Testosterone Therapy have raised awareness and concerns over a growing number of lawsuits involving Testosterone products.
On January 31, 2014, the U.S. Food & Drug Administration, (FDA), issued a Safety Announcement, “FDA Evaluating Risk of Stroke, Heart Attack & Death with FDA-Approved Tesosterone Products“, as part of their Drug Safety Communications, that confirmed an ongoing investigation into the risk of stroke, heart attack and death in men that had used tesosterone products. The Safety Announcement noted that the FDA was continuing to evaluate information from two recently released studies which had prompted it to reassess safety issues linked to the products. Patients that have been prescribed testosterone should not stop taking their prescribed products without discussing questions and concerns with their health care prescriber. Health Care professionals are cencouraged to report side effects to the FDA MedWatch Program.
NEW TESTOSTERONE STUDIES AMID GROWING CONCERNS
The FDA’s Safety Announcement was prompted by two recently released studies. These studies are discussed below.
A November 2013 study of older men in the U.S. Veteran Affairs health system, published in the Journal of the American Medical Assocation (JAMA), considered men with low serum testosterone and were undergoing imaging of the blood vessels through a coronary angiography to assess their coronary artery disease. On the average, men in the study were sixty (60) years old and some already had underlying cardiovascular disease. This November 2013 JAMA “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels” study suggests a 30% increased risk of stroke, heart attack and death in those prescribed testosterone therapy.
Alarmingly, the authors expressed their concerns as follows: “These findings raise concerns about the potential safety of testosterone therapy.” As a result, they called for more studies, “including randomized controlled trials are needed to properly characterize the potential risks of testosterone therapy in men with comorbidities.”
Another observational study, “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men“, published January 29, 2014, found an increased risk of heart attack in older men, as well as younger men with pre-existingg heart disease who were prescribed testosterone therapy. In fact, this particular study reported a 2x increase in the risk of heart attack among men aged 65 and older within 90 days following the first prescription. In men younger than 65, with a pre-existing history of heart disease, the study reported a 2x-3x increased risk of heart attack in the first 90 days following a prescription. Meanwhile, younger men without any history of heart disease that filled a prescription were not found to have an increased risk of heart attack.
Questions over the safety and effectiveness of Testosterone therapy not only prompted the January 2014 FDA Safety Communication discussed above, but have also recently prompted a public statement by the Endocrine Society. On February 7, 2014, the Endocrine Society released “The Risk of Cardiovascular Events in Men Receiving Testosterone Therapy, An Endocrine Society Statement”. The February 2014 Endocrine Society Statement underscores the need to inform patients of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy. The society directs physicians to their clinical practice guidelines on testosterone therapy and hypogonadism. In doing so, the Endocrine Society recognized that many patients and the increase in the use of testosterone was for purposes not approved by the U.S. Food & Drug Administration (FDA). In fact, they appeared particularly concerned because “many patients in the United States are being prescribed testosterone for the treatment of age-related symptoms or age-related decline in testosterone levels, for which testosterone therapy has not been approved by the Food and Drug Administration.”
Lawsuits by patients that were using testosterone therapy have begun because some men have suffered side effects resulting in death. Others have suffered strokes or heart attacks and been left to deal with the aftermath of these conditions. The studies noted above, as well as the FDA’s Safet Announcement, all indicate there is a potential for increased risk of adverse side effect. Arguably, these were not warned about and may have been, or should have been known and disclosed by the manufacturers.
While Testosterone Therapy was originally approved, by the U.S. Food & Drug Administration (FDA), only for hypogonadism, use has become widespread. A diagnosis of hypogonadism involves medical testing and diagnosis with the development of a treatment plan. Hypogonadism is a discrete medical condition and is not as common as testosterone therapy marketing materials would have one believe. Investigative reports have revealed that older men suffering from low sex drive, or libido, as well as fatigue, irritability and muscle loss, have been the targets of marketing efforts by manufacturers. Self directed and subjective questionnaires on line have allowed many to “self-diagnose” themselves as suffering from Low T and prompted them to seek out testosterone therapy. As a result, unwitting men have sought and obtained testosterone therapy and were not
Lawyers handling lawsuits involving testosterone therapy, or arising out of the use of testosterone for “Low T“, are becoming increasingly known as “Testosterone Lawyers” or “Testosterone Attorneys“. Ideally, these lawyers have past experience handling hormone related lawsuits or litigation, like the YAZ YASMIN LAWSUITS, or other similar mass torts.
Use this link to contact a knowledgeable Testosterone Lawyer from our office for a FREE CASE EVALUATION.
We are accepting and evaluating cases of men that suffered a stroke or heart attack while using testosterone products for Low T. We are also investigating cases on behalf of the remaining survivors, or family members, of someone that passed away while using a testosterone product for Low T.
Click on this link to visit the post depicted below, which discusses a USA Today article – Testosterone Therapy Doubles Heart Risk in Older Men – by the Author of this Farmer Jaffe Weissing Blog entry, Gabriel F Zambrano: