Injectable drugs are pictured inside an injection room
Injectable drugs are pictured inside an injection room at a hospital in Shanghai May 4, 2014. Picture taken May 4, 2014. Reuters/Aly Song

The Food and Drug Administration (FDA) recently issued a guideline for the pharmaceutical companies that manufacture testosterone-based drugs to clearly include a label on such drugs, stating that it could increase the rate of occurrence of heart attack and stroke.

In addition, it has warned the physicians not to prescribe the drugs to men with specific medical conditions and for treatment of symptoms associated with aging. The FDA has only approved the use of testosterone for cases where it is not produced by the testicles, or in case of damage from an infection. The use of the drug has not been approved for treatment of symptoms associated with age or for improvement of sexual drive.

The agency took a decision to reassess the effect of testosterone-based drugs in January 2014 when a research study revealed that the use of drugs has increased the rate of occurrence of heart attacks among men.

Testosterone is used by a majority of American men in their 40s to treat the problems associated with aging, including reduced sexual drive, low libido and reduced energy levels. An enormous spike in the number of testosterone users took place after a marketing campaign in 2000. According to the statistics shared by the FDA officials in a meeting, around 2.3 million men were being treated with testosterone therapy in 2013.

According to the FDA's spokesperson, the exact wording of the label warning has not been decided yet, however, the manufacturing companies have been asked to reply to the FDA's guideline. Any official word on the date of implementation of the new guideline is awaited from the agency.

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