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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

Hormone therapy in transgender adults appears safe

February 25, 2015
A literature review recently published in the Journal of Clinical and Translational Endocrinology suggests that use of hormone therapy in transgender adults is…
FDA News

Flibanserin to treat hypoactive sexual desire disorder in premenopause goes back to FDA

February 17, 2015
Sprout Pharmaceuticals has resubmitted a new drug application to the FDA for flibanserin, an investigational therapy to treat hypoactive sexual desire disorder in women…
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Hormone replacement therapy increases risk for ovarian cancer

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Women who used hormone replacement therapy — even only for a few years — demonstrated an increased risk for serous and endometrioid ovarian cancer, according…
CME
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Low- and No-Calorie Sweeteners in Weight Management: What Do You Need to Know?

This activity is supported by an educational grant from the American Beverage Association.

The use of low- and no-calorie sweeteners continues to grow as consumers continue to purchase foods and beverages…
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CME
Obesity Consults: Volume 2, Number 4 Obesity and the Cardiovascular System

Obesity Consults: Volume 2, Number 4
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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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FDA News

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…
In the Journals

Hormone therapy in transgender adults appears safe

February 25, 2015
A literature review recently published in the Journal of Clinical and Translational Endocrinology suggests that use of hormone therapy in…
FDA News

Flibanserin to treat hypoactive sexual desire disorder in premenopause goes back to FDA

February 17, 2015
Sprout Pharmaceuticals has resubmitted a new drug application to the FDA for flibanserin, an investigational therapy to treat hypoactive sexual…
In the Journals

Hormone replacement therapy increases risk for ovarian cancer

February 12, 2015
Women who used hormone replacement therapy — even only for a few years — demonstrated an increased risk for serous and endometrioid…
In the Journals

Longer term use of IUD or implant found effective in prospective study

February 10, 2015
Both the etonogestrel implant and the 52-mg levonorgestrel IUD are safe and effective when used beyond the current FDA-approved usage duration…
In the Journals

Vertebral fractures, cortisol secretion linked in postmenopausal women with type 2 diabetes

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Vertebral fractures were associated with cortisol secretion and sensitivity in postmenopausal women with type 2 diabetes, according to research…
Rachel Mackey In the Journals

Insulin resistance-related lipoproteins linked to diabetes risk

January 28, 2015
A lipoprotein-based insulin resistance index, very low density lipoprotein particle concentration and size, triglycerides and their ratio with HDL
In the Journals

Low-dose HT similar to standard dose, placebo for some CV effects

January 27, 2015
In postmenopausal women undergoing hormone therapy, a low-dose regimen does not appear to differ from the standard dose or placebo in its effects on…
Abe Morgentaler In the Journals

Testosterone therapy could benefit CV health, contrary to several studies

January 27, 2015
No convincing evidence exists to link increased cardiovascular risks with testosterone therapy, according to a review published in Mayo Clinic
David Gaist In the Journals

Long-term hormonal contraceptive use linked to increased brain tumor risk

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