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Eric T. Chaffin
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FDA Approves New Testosterone Therapy Treatment during Investigation of Heart Attack Risk

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A new testosterone therapy treatment is on the market and FDA-approved.  Endo Pharmaceuticals Inc. made the announcement on March 6th, 2014 about its product, AVEED, an injection for men with hypogonadism, or low testosterone.  It was approved on March 5th, 2014.

AVEED (testosterone undecanoate) is an injection that is administered at a hospital, clinic or doctor’s office.  A second dose of AVEED is given 4 weeks after the initial dose, and the patient receives an injection every 10 weeks after that second injection.

This drug approval comes on the heels of the FDA announcing plans to investigate the risk of heart attack, stroke, and death in men taking testosterone therapy treatments.  On January 31st, 2014 the FDA stated it has “been monitoring this risk and decided to reassess this safety issue,” after two recent studies found a possible increased risk of adverse effects in men taking a form of testosterone therapy treatment.

Testosterone Therapy Treatment & Serious Side Effects

There are several serious side effects linked to the use of testosterone therapy treatment.  A study published in November 2013 in the Journal of the American Medical Association (JAMA) found “adverse” effects among those using a form of testosterone therapy.

In a more recent study published in PLOS One, entitled Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men, researchers found that men aged 65 and older had twice the risk of suffering from a heart attack.  Younger men with a history of heart disease had three times the risk of suffering from a heart attack, but there was no additional risk found among those without a family history of the disease.

The new injectable testosterone therapy treatment, AVEED, also comes with its own list of serious side effects.  According to the prescribing information for this drug, there is a risk of serious pulmonary oil microembolism (POME) and anaphylaxis.  POME reactions can include throat tightening, chest pain, dizziness, the urge to cough, dyspnea, and syncope.  Anaphylaxis is a serious allergic reaction that can involve the skin, nose, throat, lungs and gastrointestinal tract.

Help for Those Suffering From Serious Side Effects

Most importantly, if you or a loved one are taking or have taken a form of testosterone therapy treatment and suffered a serious side effect you should immediately contact your doctor.  Only your physician will be able to determine if you should stop treatment and what is causing your adverse reaction.

If you or a loved one took or are taking a form of testosterone therapy treatment and experienced serious side effects you may be entitled to compensation.  You should contact a testosterone therapy treatment attorney today for advice.