Manufacturers of Testosterone will from now on be required to change the labels of their drugs to indicate and warn potential users that the drugs can increase the risk of heart attacks and strokes. This is according to a new directive by the Food and Drug Administration, which is also requiring the manufacturers to indicate that testosterone drugs cannot be prescribed to treat age-related symptoms in men. Such as low sexual drive.
The decision by the FDA comes after sustained controversy over allegations of inappropriate marketing, which has attracted regulatory scrutiny in the recent past. The agency had initially rejected citizens petition to strengthen warnings, but last fall convened meeting that recommended drug makers to study heart risks associated with the testosterone products. FDA staffers had already noted that 21% of men who used the products did not have any lab work to indicate that they needed the treatment.
Following months of studies and deliberation the FDA found out that testosterone products caused an increased risk for heart problems especially in men. Producers are now required to conduct further clinical trials to ascertain risks associated with the product. Companies have been given until Tuesday to respond to the same, with precise labelling of the warning to be worked out over time.
The FDA directive comes on the heels of reports that the use of testosterone products has more than quadrupled since 2000, for men in their 40s. Marketing campaigns have been attributed to the increased usage especially on suggestions that they are a solution to low energy and low libido. In 2013 alone more than 2.3 million Americans were being treated with testosterone therapy according to a material in the hands of the agency.
The FDA has however approved testosterone therapy for medical conditions, especially on genetic disorders, such as the inability of testicles to produce testosterone. The drugs are however not approved for conditions associated with aging or declining sexual drive.
Abraham Morgentaler a clinical professor at Harvard Medical school has already taken swipe of FDA decision arguing that there are only ‘four flawed studies’ that indicate heart risks associated with the testosterone products compared to ‘several dozen studies’ that show benefits.