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FDA Launches Investigation of Testosterone Supplements

The US Food and Drug Administration (FDA) has announced an investigation of the FDA-approved testosterone products. Recent medical studies have demonstrated that there is increase in the risk of serious adverse cardiovascular outcomes with Testosterone supplements.

The FDA is alarmed by the results of two recent medical studies, that revealed that men taking the testosterone supplements have an increased risk of death, heart attacks (Myocardial Infarction, MI) and ischemic stroke.

Testosterone Use Increases Heart Attacks 36% in first 90 days

In the latest study, men treated with testosterone were more likely to have an MI in the first 90 days after starting the medication. In the three months after the start of testosterone therapy, the risk of MI overall was increased by 36% and was even higher in older men. For those aged 65 years and older, the risk of MI was more than twofold, over 100% higher in the 90 days after filling the prescription.

In the older second study analysis of Veterans Affairs (VA) patients, found that testosterone therapy in men was linked with an increased risk of death, MI, and ischemic stroke.

More Than 50,000 Patients Study

This this study of 55,593 men who received a new prescription for testosterone therapy, and these men were compared with 167, 279 who filled a prescription for phosphodiesterase type 5 (PDE5) inhibitors Viagra and Cialis. The PDE5 inhibitors were selected as a comparator arm because many indications for use are similar to testosterone therapy and these agents are not associated with an increased risk of cardiovascular events.

To assess the effect of testosterone therapy, the researchers compared the rate of MI incidence in the 90-day postprescription interval with the incidence rate in the preprescription interval.

The pre- to postprescription relative risk of MI for all patients was 1.36 (95% CI 1.03–1.81). For men 65 years and older, the relative risk of MI 90 days after starting testosterone therapy was 2.19 (RR 1.27–3.77). For those younger than 65 years, there was only a trend toward a higher risk of MI.

In the comparator arm, those treated with PDE5 inhibitors had similar rates of MI in the period before they filled their prescription, but there was no signal of risk in the postprescription period, even in the older patients.

When investigators stratified patients into two groups—those with existing coronary heart disease and those without—they found testosterone therapy in those aged younger than 65 years was associated with a twofold increased risk of MI. For those of the same age but without heart disease, there was no signal of risk.

In older patients, regardless of heart-disease history, treatment with testosterone increased the risk of MI.

FDA Warns About Non Approved Testosterone Use

The agency states that testosterone products are approved for use in men with low testosterone levels. Low testosterone levels occurs because of testicular failure to produce testosterone from a genetic condition or chemotherapy. Other medical conditions include problems with the hypothalamus or pituitary gland that result in low testosterone levels.

The FDA says that these testosterone therapies are not approved for men with low levels without the associated medical conditions.

Testosterone Sales Pushed

Testosterone therapy, is heavily marketed with direct-to-consumer advertising, the drug branded as “a fountain of youth” to treat low energy levels and improve sexual function in men. As a result, millions of men might be taking testosterone therapy, and yet the long-terms risks, including cardiovascular risks, have never been fully characterized. In 2013 the sales of testosterone exceeded $2 Billion.

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