FDA Demand Labelling Change On Low Testosterone Drugs

(Last Updated On: April 29, 2019)

New FDA Statement On Testosterone Drugs

New Rules on Product Labelling

February 28th 2015

Following on from their main announcement back In January 2014, the FDA have updated their statement concerning the labelling of prescription drugs used to treat low testosterone.

ucm218078Following on from new study reports that have identified a potential for health risks, The FDA have requested that all manufacturers comply by altering their labelling to clearly identify and warn the patients of the possible increased risk of heart problems and strokes caused by the use of low testosterone drugs.

The FDA have also requested that (either jointly or independently) drug manufacturers carry out more in depth clinical trials to study and identify these potential health risks

They have also advised health care professional to be more thorough when discussing and determining a patients suitability for low testosterone treatment.

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