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In recent years, primetime television has been saturated with commercials advertising drugs to treat a condition called low testosterone, also known as low T. The pharmaceutical companies’ direct-to-consumer marketing appears to have worked, as annual testosterone prescriptions have increased more than five-fold from 2000 to 2011.

But who really needs low T treatment?

Prescription testosterone drugs – which include a topical gel, skin patch, buccal system and injection – are only FDA-approved for men with low T caused by a medical condition that affects a man’s ability to produce testosterone, such as hypogonadism. The agency’s recent testosterone safety announcement says that no FDA-approved testosterone drug is approved for use in men with low T who do not have an associated medical condition.

But 5.3 million testosterone prescriptions were written in the U.S. in 2011, many of which were prescribed to counteract a man’s age-related hormone decline and to improve sex drive and muscle mass, according to a LiveScience article. Further, a study found only 50 percent of testosterone users had been diagnosed with hypogonadism, and about 25 percent didn’t even have their testosterone levels measured before beginning treatment.

The spike in popularity appears to be driven the drug companies’ marketing campaigns targeting middle-aged men, in addition to the development of low T centers all over the country.

However, recent studies are prompting men to reassess the benefits and risks of taking testosterone. A 2014 study found the drug may increase some men’s risk of heart attack by as much as threefold. In addition, a study published in JAMA in November 2013 suggests a 30 percent increased risk of stroke, heart attack and death in older men taking testosterone.

In response to the studies, the FDA announced that it’s evaluating the risk of cardiovascular events in men taking prescription testosterone drugs.

“Although physicians should continue to discuss the benefits of testosterone therapy with patients, it is also important to inform patients that long-term risks are unknown and there is a possibility that testosterone therapy might be harmful,” the researchers from the 2013 study said.

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