Men having trouble in the bedroom use Low-T drugs to give their testosterone levels a boost. However, these drugs are only approved to treat certain medical conditions.
The frequency of the off-label use of testosterone drugs has prompted the FDA to call on pharmaceutical manufacturers to collaborate on a single trial that would analyze testosterone enhancers as a lifestyle drug.
A cooperative single trial would be faster, more convenient and less costly for all parties with a stake in Low-T medications. It would provide much-need information on a popular class of drugs that is being used for anti-aging and sexual enhancement.
The Argument For A Multi-Manufacturer Trial
In March, the FDA required manufacturers of testosterone treatments to put warnings about possible heart attacks and stroke on the drug’s labeling. Additionally, the FDA did not want doctors to prescribe these drugs to aging men with sexual dysfunction. The ruling was supported by an advisory panel that voted 14-1 for the drugs only to be used for medical issues like brain damage, tumors or genetic disorders.
Despite these regulations, men are continuing to seek out testosterone therapy to improve testicular function or to treat other age-related conditions. In an issue of the New England Journal of Medicine published on August 20, the FDA cites an increase in the use of testosterone drugs to treat a lacking libido.
The amount of male Americans using testosterone therapy increased from 1.3 million to 2.3 million from 2009 to 2013, according to the FDA.
Previous studies on Low-T as a lifestyle drug do exist, but data on the benefits of hormone therapy for older men are inconclusive or contradictory.
Dr. Christine Nguyen, an FDA deputy director of safety, wants the manufacturers to conduct tests that would give information about the drug’s dosage, advantages and side effects.
“The benefits and risks of testosterone therapy have not been established for the treatment of men who have low testosterone levels due to aging, even if there are symptoms that seem related to the low testosterone,” Nguyen said.
Will Low-T Manufacturers Agree?
Experts question if Low-T drugs will increase the likelihood of heart attack and stroke in older men. They wonder what it would mean if a pharmaceutical product could be prescribed to counteract the natural process of aging.
If pharmaceutical manufactures want to keep market sales steady, they will have to secure information that illustrates the safety and effectiveness of Low-T drugs.
AbbVie, the maker of Androgel, and Eli Lilly, the maker of Axiron, have stated that they are going to work toward researching testosterone drugs to assure that prescribing them for lifestyle improvement is in patient’s best interests.
“AbbVie and other sponsors of prescription testosterone treatments are working with the FDA to determine the best path forward for a clinical trial,” according to an AbbVie spokesperson.
Similarly, J. Scott MacGregor, Eli Lilly’s global communications director, said, “We’re continuing to work closely with the FDA in the best interests of men who use testosterone therapy.”
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