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News of the FDA investigating the risk of heart attack, stroke and death in men taking testosterone therapy treatments appears to already be having an impact on the sale of the company’s stock, and not just in the United States.  In an article published in The Sydney Morning Herald, shares fell for Acrux, an Australian biotech firm behind Axiron, to $2.08 with “more than 2.85 million shares changing hands as investors reacted to the note.”

Lilly USA, LLC signed an agreement with Acrux in March 2010.  This “exclusive global licensing” agreement was the largest at the time for an Australian biotechnology firm.

Testosterone Therapy Sales

Since 1993 there has been a 500% increase in the prescription sales of testosterone products.  According to the Journal of the American Medical Association, testosterone therapy is prescribed for about 2.9% of men 40 years of age and older.

Testosterone therapy is available in several forms including the transdermal patch, buccal system (applied to the inner cheek or upper gum), injection and the topical gel.

About $200 million in sales of the Acrux drug, Axiron, were generated by Eli Lilly in 2013.  Axiron is just one form of testosterone therapy available on the market.  It’s a topical solution applied to a patients armpits.  There are several possible side effects from the use of Axiron including: sleep apnea; swelling of the body, feet or ankles; blood clots in legs; lower sperm count is used in large doses; signs and symptoms of enlarged prostate can worsen; painful, enlarged breasts; and a possible increased risk of prostate cancer.

FDA Announces Plans to Investigate Heart Attack Risk

Two studies, one recently published in PLOS One, has led to the FDA on January 31, 2014 to investigate the risk of heart attack, stroke and death in men taking testosterone products.

The first study in November 2013 appeared in the Journal of the American Medical Association.  It found that men who had a coronary angiography or a method to evaluate coronary artery disease (CAD), with a low testosterone level that used testosterone therapy had an increased risk of “adverse outcomes.”

The more recent study, Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription for Men, found men aged 65 and older have twice the risk of suffering from a heart attack when using testosterone therapy.  It also found that younger men with a history of heart disease were three times as likely to have a heart attack.

The FDA “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack or death.”

If you are currently taking a form of testosterone therapy remember to contact your doctor before discontinuing use of the drug.

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