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Low-T drug approved amid FDA safety probe


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Slightly more than a month after the U.S. Food and Drug Administration announced its review of testosterone therapy safety, a drug company announced that the very same government agency had approved a testosterone drug.

Endo International in Dublin announced March 6 that its operating company received FDA approval for its injectable drug used for the treatment of Low-T.

Ironically, the FDA announced Jan. 31 that it “is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Those are the FDA’s words quoted.

The FDA did not connect the dots matching cardiovascular injury and testosterone drugs with indelible ink. It merely decided to examine, based on two recently published studies, whether the eyebrow-raising science has been on the money. And it approved a testosterone drug amid rising safety concerns.

The first study that got the FDA’s attention appeared in the November 2013 edition of the Journal of the American Medical Association. Subjects in the study were older men treated in the U.S. Department of Veterans Affairs health care system.

“The men included in this study,” the FDA wrote, “had low serum testosterone and were undergoing imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease. Some of the men received testosterone treatment while others did not. On average, the men who entered the study were about 60 years old, and many had underlying cardiovascular disease. This study suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.”

The second study that caused the FDA to scrutinize testosterone was published Jan. 29 by the online journal PLOS ONE. The FDA wrote that this study “reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy.”

The FDA continued, “The study reported 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…”

The experienced attorneys at Reich & Binstock are following this investigation of testosterone safety and are offering a free consultation to anyone who used testosterone and since suffered heart attack or stroke. Such victims may be entitled to compensation.

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