FDA introduces tougher regulations on testosterone products

Food and Drug Administration made statements regarding the safety of widespread testosterone replacement therapy.

Almost all from FDA advisory panel agreed that it was necessary to label the products that replace testosterone. The commission of experts from FDA almost unanimously voted in favor of changes in the instructions concerning use of testosterone replacement drugs. These means are aimed at reduction of widespread practice for treatment of hypogonadism that develop with age. The commission also pointed to the necessity of additional research to prove the clinical benefit and, consequently, security of these testosterone replacement remedies.

The votes of panels participants were 20 to 1, among which 16 members voted for the safety study arranged for particular indications and 4 members asked to conduct comprehensive studies. Only 1 person was against any studies.

Currently, testosterone products have two indications. One of these is for testosterone replacement in men with different types of hypogonadism, including such diagnoses as Klinefelter syndrome, cryptorchidism, testicular damage due to chemotherapy or heavy metal poisoning it remained unchanged.

Changes referred to another indication, which is hypogonadotropic hypogonadism that can be congenital and acquired: idiopathic gonadotropin deficiency, LHRH or damage to the hypothalamic-pituitary damage due to transmission of radiation, tumor, or trauma.

The use of the term "idiopathic" explain why the drugs have become widely prescribed for men with low levels of testosterone that occurred because of aging, and for men with clinical signs and symptoms of testosterone deficiency, in spite of the fact that low testosterone was not diagnosed, just because the tests were not conducted.

What caused the popularity?

As FDA informs, the sales of testosterone products considerably increased in the period 2009-2013. The frequency of use of these remedies increased by 65%, while the number of relevant appointments increased from 1.3 mln in 2010 to 2.3 mln prescriptions in 2013. 70% of all prescriptions for testosterone products were written for men aged 40 to 64 years. The biggest increase in the number of appointments has fallen to this age group. It is noteworthy that only about half of the patients, who received testosterone replacement therapy, were diagnosed with hypogonadism. Moreover, 25% of men taking testosterone have no any records on testosterone tests before the treatment and 21% of them had never had it tested during the treatment that was conducted.

Why wording matters

Since, on the one hand, as the experts FDA assert, the benefits of using testosterone for hypogonadism due to aging remains unclear, and, on the other hand, there were reports of the increased risk of cardiovascular disease as a result of such treatment, FDA decided to toughen the wording of the second prescription, removing the word "idiopathic" from it. Thus, it is intended to give a more precise description of patients for replacement therapy.

Benefits outweigh the risk currently

The review of the cardiovascular risk associated with the use of drugs based on testosterone was published previously. Information about the risk of severe side effects of the cardiovascular system is currently controversial. Although some studies suggest an increased risk in men, receiving testosterone, compared with those who do not receive such treatment, these works have some drawbacks, and their results are not proved by other studies. The committee concluded that the benefits of using testosterone continue to exceed the risks, but emphasized in the statement that preparations for replacement therapy should be administered only to the patients who have testosterone deficiency, established by lab tests and not proven only by the presence of clinical signs and symptoms.