Backlash over testosterone replacement drugs builds with FDA warnings

pharmafile | October 26, 2016 | News story | Research and Development FDA, FDA Warning, low t, prescription testosterone 

The backlash against the over-prescription of ‘testosterone boosters’ continues in the US, with the FDA taking action to add clear warnings of the potential side-effects of the drugs on labels. The new warnings will notify the readers of the potential for serious side-effects upon use of the drug, such as increased risk of heart attacks and strokes.

Prescription testosterone has become big business for pharmaceutical companies and is generally advertised to those who may be suffering from ‘low T’. The market is expected to grow to be worth $5 billion annually by next year. The increase in the number of users of the prescribed testosterone has led to increased scrutiny and litigation from those who believe they have suffered from the ill effects of the drug. In 2015, more than 1,300 men grouped together to sue drug companies based upon misleading advertising because of the side-effects they believe they had endured at the hands of the drug. The number and severity of the side-effects is a particular cause for concern – they include heart attacks, stroke, depression, liver toxicity, male infertility, aggressive behaviour and hostility.

The prescription of testosterone for genuine medical conditions is accepted as a necessary treatment when they result from certain medical conditions, such as hereditary conditions, damage to testicles, chemotherapy or infection. However, there is an increasing body of evidence suggesting that men are being targeted and treated for the natural decline in testosterone that occurs with the natural aging process. A Live Science study, in 2013, found that close to 25% of men who received prescription testosterone were not measured for the levels of the hormone in the system.

On top of this, researches at Georgetown University collected data upon the results of men taking prescription testosterone and found there to be no consistent health benefits to the medication. With advertising generally pointing towards symptoms associated with aging, testosterone did not provide the solution to problems with sexual function, mood and cognitive function or cardiovascular health.

The FDA released a statement to go along with the changes to labelling that highlight the potential dangers and makes mention of the potential for a dependence upon the hormone replacement:

“The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS abuse. In addition to the new Warning, all testosterone labelling has been revised to include information in the Abuse and Dependence section about adverse outcomes reported in association with abuse and dependence of testosterone/AAS, and information in the Warning and Precautions section advising prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.”

Ben Hargreaves

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