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FDA Votes To Change Labels On Testosterone Replacement Products

Brigitte Barrera2 years ago

In a 20 to 1 vote, a Food and Drug Administration (FDA) advisory board has decided to alter the labeling on all testosterone replacement products. Current labels were deemed misleading and the products are being misused by the public.

FDA Advisory Board Decision Concerning Testosterone

According to Medscape, the FDA advisory panel was made up of 21 people from the Bone, Reproductive, and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

The combined committes made their decision to change testosterone replacement product labels with the hope of reducing the use of these products for “age-related” hypogonadism. Furthermore, the committee decided that extensive research is needed to determine safety and benefits of said products. 16 voted to approve a study looking into particular aspects for safety purposes, especially cardiovascular disease.

Current Testosterone Labels & Concerns

The current labels have two claims.

First, that the testosterone replacement should be used by men to aid in the treatment of testicular damage resulting from chemotherapy or heavy metals, and congenital or acquired primary hypogonadism; including conditions such as cryptorchidism, Klinefelter's syndrome. This claim was supported by the board.

The second claim can be found on the products as “hypogonadotropic hypogonadism (congenital or acquired): Idiopathic gonadotropin or luteinizing-hormone–releasing (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation”.

According to the board, the word “idiopathic” is suggesting to men that it helps to regulate low testosterone levels, or low T, due to aging.

From 2009 to 2013, there was a 65% increase in testosterone therapy. 70% of the prescriptions during this 5 year time span were given to men between the ages of 40 to 65.

21% of the men using the products were not tested for low T while 25% were not tested prior to starting treatment.  

About 50% of men on testosterone therapy were diagnosed with hypogonadism.

Dr. Hylton V. Joffe, director of the Division of Bone, Reproductive, and Urologic Products at the FDA, did state that the “benefit is unclear in men diagnosed with hypogonadism due to no apparent cause other than older age.” Furthermore, that this was the reason the FDA was concerned that the labeling is not accurate.

In advertisments, the low T products are claiming to improve quality of life and sexual performance; this is speculated as a cause for the testosterone therapy increase, and all companys making this claim have been sent warning letters.

New Testosterone Product Labels

New labeling is still under discussion.

Recommendation of testosterone testing and proper diagnosis along with a list of symptoms is likely to be on the new label.

Testosterone replacement products will have more precise labeling.


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