The FDA evaluating Risk of Stroke, Heart Attack & Death with FDA-approved Testosterone Products

Doctors are the ones who need more education here…

AUDIENCE:
Cardiology, Urology, Family Practice

FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products
Newer studies have prompted the FDA to ask for warnings on testosterone therapy and for doctors to educate their patients on possible increased risks of heart disease.

ISSUE:
FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.

BACKGROUND:
Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.

RECOMMENDATION:
At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Sources and Studies:

  • FDA Safety Information ucm384225 01/31/2014
  • FDA Drug Safety Communication ucm383904 01/31/2014
  • PLOS One January 29, 2014 DOI: 10.1371/journal.pone.0085805
    Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men
  • JAMA. 1764051 2013;310(17):1829-1836. doi:10.1001/jama.2013.280386 Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels November 6, 2013
  • These newer studies have prompted some to ask for warnings on testosterone therapy and to educate their patients on possible increased risks of heart disease. Doctors are the ones who need more education here.” Testosterone Therapy Does Not Cause Heart Attacks, HuffingtonPost, by Jen Landa, M.D. 02/04/2014

Testosterone is not the Help some hoped for when Women go through Menopause early

Effects of physiologic testosterone therapy on quality of life, self-esteem, and mood in women with primary ovarian insufficiency

Testosterone isn't the help some hoped for when women go through menopause early
The North American Menopause Society is the leading nonprofit scientific organization devoted to the health and quality of life of women at midlife and beyond.

With plummeting hormone levels, natural menopause before age 40 can put a damper on women’s mental well being and quality of life. But bringing testosterone back up to normal may not bring them the boost some hoped for, found a new study published online today in Menopause, the journal of The North American Menopause Society (NAMS).

“… Our findings suggest that augmentation of standard estrogen/progestin therapy with physiologic testosterone therapy in young women with POI neither aggravates nor improves baseline reports of quality of life or self-esteem and had minimal effects on mood… ”

Abstract

Objective:
Women with primary ovarian insufficiency (POI) display low androgen levels, which could contribute to mood and behavioral symptoms observed in this condition. We examined the effects of physiologic testosterone therapy added to standard estrogen/progestin therapy on quality of life, self-esteem, and mood in women with POI.

Methods:
One hundred twenty-eight women with 46,XX spontaneous POI participated in a 12-month randomized, placebo-controlled, parallel-design investigation of the efficacy of testosterone augmentation of estrogen/progestin therapy. Quality of life, self-esteem, and mood symptoms were evaluated with standardized rating scales and a structured clinical interview. Differences in outcome measures between the testosterone and placebo treatments were analyzed by Wilcoxon rank sum tests.

Results:
No differences in baseline characteristics, including serum hormone levels (P > 0.05), were found. Baseline mean (SD) Center for Epidemiologic Studies Depression Scale scores were 10.7 (8.6) and 9.2 (7.8) for testosterone and placebo, respectively (P = 0.35). After 12 months of treatment, measures of quality of life, self-esteem, and mood symptoms did not differ between treatment groups. Serum testosterone levels achieved physiologic levels in the testosterone group and were significantly higher compared with placebo (P < 0.001). Baseline testosterone levels were not associated with either adverse or beneficial clinical effects.

Conclusions:
A 150-μg testosterone patch achieves physiologic hormone levels in women with POI. Our findings suggest that augmentation of standard estrogen/progestin therapy with physiologic testosterone therapy in young women with POI neither aggravates nor improves baseline reports of quality of life or self-esteem and had minimal effects on mood. Other mechanisms might play a role in the altered mood accompanying this disorder.

Sources: