Failing to report side effects and correctly informing middle-aged and older men about potential cardiovascular risks could constitute a prosecution for pharmaceutical litigation.
Sacramento, CA (PRWEB) February 12, 2014
Because recent studies have shown that testosterone therapy is associated with an increased risk of strokes and cardiovascular problems such as heart attacks, personal injury lawyer John M. O’Brien raises concern regarding the lack of awareness of the risks of Low T treatments. (source: Plos One - January 29, 2014 - Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men)
Considering the statement issued by the Endocrine Society, personal injury lawyer John M. O’Brien recommends that middle-aged and older men who are considering testosterone supplementation for age-related declines should be informed of the potential cardiovascular risks. Also, attorney O’Brien believes that it may be safer not to administer testosterone therapy to men who have had a cardiovascular event (such as myocardial infarction, stroke or acute coronary syndrome) in the preceding six months.
Quoting the The U.S. Food and Drug Administration (FDA) safety announcement(source: FDA - January 31, 2014 - http://www.fda.gov/drugs/drugsafety/ucm383904.htm):
“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.”
One of the conducted studies revealed a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription. Younger men without a history of heart disease who filled a prescription for testosterone, however, did not have an increased risk of heart attack.
John M. O’Brien advises that patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy for age-related decline in testosterone levels and symptoms.
“Physicians and health care professionals have the legal responsibility to provide patients with information and report side effects involving prescription testosterone products to the FDA MedWatch program. Failing to report side effects and correctly informing middle-aged and older men about potential cardiovascular risks could form the basis for pharmaceutical litigation,” said attorney O’Brien.
About John M. O’Brien
John M. O'Brien began his career in 1990 and in 1996, he formed his own firm and has since specialized in providing personal and individual legal services to injured people. He enjoys an excellent reputation for aggressive advocacy and integrity as well as an impressive record of significant jury verdicts, arbitration awards, and settlements.
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