Testosterone Drugs: No Clear Evidence of Cardiac Risks in Germany
Germany's Federal Institute for Drugs and Medical Devices has assessed potential cardiac risks associated with testosterone treatments. The conclusion is that no consistent evidence of increased cardiovascular risk has been found.
Germany's Federal Institute for Drugs and Medical Devices (BfArM) has concluded that there is no consistent evidence of an increased risk of cardiovascular diseases associated with testosterone-containing medicines. A European risk assessment by the PRAC concluded that treatment of men with testosterone deficiency (hypogonadism) does not show a clear link to an increased risk of heart attacks, although product information will be updated.
The updated guidelines mandate that testosterone therapy should only be initiated when hypogonadism in men is confirmed by both clinical and laboratory evidence. Testosterone serum concentrations must be regularly monitored before and during therapy. Product information will also include warnings about potential changes in hemoglobin, hematocrit, liver function, and lipid profile, alongside the need for regular checks.
Furthermore, treatment must be discontinued for patients with severe heart, liver, or kidney insufficiency, or ischemic heart disease. As of April 1, 2015, testosterone drugs may only be marketed with updated product information.
BfArM has also instructed manufacturers to conduct thorough reviews of the cardiovascular and thromboembolic risks of their testosterone drugs and their use in elderly patients, submitting these evaluations to the agency. Pharmaceutical companies have one month to appeal this decision.