FDA Restricted Prescribing Testosterone
Food and Drug Administration (FDA) has demanded from the pharmaceutical manufacturers to make a warning that the use of testosterone meidcines is associated with an increased risk of cardiovascular disease - heart attacks and strokes in their instructions. Indications for the use of these drugs should be limited to strictly defined list of diseases.
In recent years, the US has sharply increased the number of prescriptions of drugs for the correction of low testosterone levels. In 2013, there were 2.3 million recipes written out that is a 75% increase compared with 2009. About 70% of patients receiving testosterone are men 40-64 years old. Reduction of testosterone at this age is normal and is not considered to be a disease.
The new FDA requirements are based on the recommendations of independent experts who recommend the agency to limit the use of testosterone medications to treat the disease in which patients require hormone replacement therapy.
In addition, the FDA mandates manufacturers of various formulations of testosterone (patches, gels, solutions for injection) to conduct additional studies to assess the cardiovascular risks associated with the use of these products.
The market volume of testosterone preparations in the US is estimated at $2 billion per year. The most popular drugs of this group in the United States are AndroGel production AbbVie.
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