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Label change required in US for testosterone drugs

by Ion Gireada on 4 March 2015
Health, Lifestyle, Medical technology     |      heart health,  low energy,  low libido,  Stroke,  testosterone drugs

All drugs containing testosterone will need new labels indicating the increased risk of heart attack and strokes associated with the hormone, US Food and Drug Administration said.

It is estimated millions of Americans use testosterone drugs, prompting FDA to mention that testosterone should not be used to treat common conditions resulting from aging such as a lower sexual drive.

Last year, the agency promised a reassessment of the safety of testosterone drugs, resulting in current recommendation. After gathering data from two clinical trials, the agency decided it is necessary to change the label of the involved drugs.

Currently, FDA now requires companies involved in producing testosterone drugs to adhere to its recommendation. The changed label will include a specific wording.

As early as 2000, testosterone drug products become popular following advertisements stating the drug can reverse symptoms such as low energy, low libido, and other conditions, all related to aging. In 2013 an estimated 2.3 million Americans took testosterone drugs, the agency said.

Dr. Aaron Katz, chairman of the department of urology at Winthrop-University Hospital in Mineola, N.Y questioned the recommendation of the panel reviewing the effects and risks of using testosterone drugs. His arguments is that results were mixed, but continued saying he supported the change of labeling.

“This is more of a wake-up call for the industry and for physicians,” he said.

Label change required in US for testosterone drugs

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