FDA Launches New Regulations Surrounding Low Testosterone Drugs
September 18th 2014
Reports In The New York Times tell us this week that an expert panel has voted by a massive margin for the FDA to place stricter regulations and control over the multi million dollar testosterone prescription drug industry
The panel voted overwhelmingly for the FDA to strictly monitor and limit the usage of low testosterone prescription drugs to men with serious health conditions such as pituitary gland issues as well as severe hypogonadism.
Director Of Heart Failure Research at Mount Sinai School Of Medicine – Michael Domanski told us that “The whole idea is to try to rein in the inappropriate advertising and use of these drugs,”
The prescribing of testosterone treatments has quadrupled in the past decade, with over 2.3 million American men being treated in 2103 alone
One of the main areas of concern is the amount of men aged 40 who have sought help with reduced libido and low energy.. something that has been encouraged by the ever increasing amount of advertising and marketing aimed at this age group.
There have been hundreds of lawsuits filed over the past year, with the majority of patients claiming that certain prescription base treatments have cause them to suffer life threatening conditions such as heart attack and stroke.. the main issue is that the manufacturers knew beforehand about the risks and failed to advise both the doctors and the patients themselves accordingly.
An official from the FDA told us that the agency had issued letters to certain sponsors over misleading advertisement and it is also hoped that the new reforms will limit the coverage provided by insurance companies.
Other experts are skeptical as to whether the restrictions would actually have much effect… Doctors on the whole can prescribe what they think is best for their patients, regardless of what is on the label…
Over the next year, the FDA plans to reassess the safety of testosterone drugs and is currently overseeing a trial being carried out by the National Institute of Health known as the ’T Trial’ which is looking onto the treatment of older men with testosterone therapy to ascertain exactly what the benefits are with regard to physical, sexual and cognitive function.
The resulted are expected out next year…..Read Full Article Here
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