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FDA requires labeling changes for testosterone therapies to reflect CV risk

March 3, 2015

The FDA has announced that manufacturers of prescription testosterone products must change their labeling to more clearly indicate approved uses and also include a warning about possible increased risk for MI and stroke.

According to a FDA drug safety communication, the agency recommends that health care professionals prescribe testosterone therapy only for men with laboratory confirmed low testosterone as a result of certain medical conditions of the brain, pituitary gland or testicles that result in hypogonadism. This is the only patient population for which these products have been approved.

In the Journals

Long-term paracetamol use may increase risk for adverse events

March 3, 2015
Researchers reported a dose-response association between paracetamol and adverse events similar to those observed with NSAIDs, including mortality, CV, gastrointestinal…

Study: No benefit from anticoagulant use in Behçet’s disease

March 3, 2015
Patients with vascular manifestations of Behçet’s disease who received treatment with anticoagulants did not benefit from the therapy given in addition to…
In the Journals

Many with AF qualify for oral anticoagulation therapy under new guidelines

March 2, 2015
Most patients with atrial fibrillation not recommended for oral anticoagulation under previous guidelines are now eligible for therapy based on the newest guidelines…
Suzanne C. Cannegieter, MD, PhD In the Journals

Data support predictive significance of superficial vein thrombosis

March 2, 2015
Researchers found that a history of superficial vein thrombosis may be predictive of venous and arterial thrombotic events and these findings may play an important role…
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Best of Lipid Forum III

Best of Lipid Forum III

This activity is supported by an educational grant from Amgen, Inc.

Appropriate therapies for various dyslipidemias remain a challenge for practitioners struggling to reduce residual risk…
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VIDEO: Intra-arterial thrombectomy trial results indicate 'formula for success'

February 25, 2015
NASHVILLE, Tenn. — Aneesh B. Singhal, MD, vice chair of quality and safety at Massachusetts General Hospital…
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CME
Obesity Consults: Volume 2, Number 4 Obesity and the Cardiovascular System

Obesity Consults: Volume 2, Number 4
Obesity and the Cardiovascular System

This activity is supported by an educational grant from Eisai, Inc. and Vivus, Inc.

Obesity is associated with a wide range of comorbid conditions, including diabetes, hypertension, sleep apnea, and…
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