The FDA will investigate the risk of cardiovascular disease and death with testosterone therapy, a move prompted by two studies that raised questions about the risk of the highly-promoted hormone.
The agency said it had been monitoring the potential risks and decided to advance its investigation after the studies reported an increased risk of stroke, heart attack, and death among men taking testosterone.
One study of U.S. Veterans Affairs data published in JAMA last November concluded that veterans taking the drug had a significantly increased risk of stroke, heart attack, and death.
The other study, reported this week in PLOS One, found an increased risk of heart attack in older men -- and also in younger men with pre-existing heart disease -- who filled a prescription for testosterone therapy.
FDA did not say when the review will be completed, but told patients not to stop taking their medications, but to talk with their doctors if they had questions.
Clinicians should consider whether the benefits of treatment will outweigh its potential risks, the agency said.
The review applies to testosterone topical gel, transdermal patch, a buccal system, and injections.
The FDA asked clinicians and patients to report adverse effects to its MedWatch program
written by Kristina Fiore
Sources http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/44081
The agency said it had been monitoring the potential risks and decided to advance its investigation after the studies reported an increased risk of stroke, heart attack, and death among men taking testosterone.
One study of U.S. Veterans Affairs data published in JAMA last November concluded that veterans taking the drug had a significantly increased risk of stroke, heart attack, and death.
The other study, reported this week in PLOS One, found an increased risk of heart attack in older men -- and also in younger men with pre-existing heart disease -- who filled a prescription for testosterone therapy.
FDA did not say when the review will be completed, but told patients not to stop taking their medications, but to talk with their doctors if they had questions.
Clinicians should consider whether the benefits of treatment will outweigh its potential risks, the agency said.
The review applies to testosterone topical gel, transdermal patch, a buccal system, and injections.
The FDA asked clinicians and patients to report adverse effects to its MedWatch program
written by Kristina Fiore
Sources http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/44081
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