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FDA rejects oral testosterone replacement drug

By Burg Simpson

September 29, 2014   Colorado Blog, Colorado Dangerous Drugs and Medical Devices

A U.S. Food and Drug Administration advisory committee has rejected an oral testosterone replacement drug proposed by Clarus Therapeutics Inc., according to The Wall Street Journal. The committee was hosted by the FDA with the intention of finding a replacement for the current method of administering testosterone treatments through gels, injections or implants.

The committee was proposed in January when the FDA released a safety announcement regarding concerns over existing testosterone replacement therapies. The move came as a response to a study done by the Journal of the American Medical Association, which determined there were potential cardiovascular risks among men prescribed with FDA-approved testosterone products.

The FDA has not confirmed that approved testosterone treatments lead to an increased risk of stroke, heart attack or death or that patients with prescriptions for such products should not stop taking them. However, the administration agreed with the study that too many men are being prescribed testosterone treatment without the proper testing, and that doctors should consider whether the risks of such treatment outweigh the benefits.

From 2009 to 2013, testosterone replacement sales rose by 65 present, with 1.3 million patients receiving prescriptions in 2010 compared to 2.3 million in 2013, according to the study.

Burg Simpson is representing men who have suffered from blood clots as a result of using Testosterone Replacement Therapy.

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