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Medicinal products containing testosterone: review of possible cardiac risks

2015.01.22

Active substance: testosterone

22.01.2015 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has reviewed the risk of cardiovascular diseases, particularly heart attacks, under treatment with testosterone.

In a letter dated 21.01.2015, the Federal Institute for Drugs and Medical Devices (BfArM) informed pharmaceutical companies about the outcome of the referral procedure and the measures now required.

Bescheid vom 21.01.2015 PDF, 126KB, File does not meet accessibility standards

(available in German only)

10.10.2014 - PRAC recommendation

The BfArM issues information on the PRAC's recommendation within a European safety review according to Article 31 of Directive 2001/83/EC--European Community.

11.04.2014 - Procedure started

The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC--European Community. This procedure was initiated at the request of the Estonian State Agency of Medicines.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Testosterone-containing medicines

To the risk assessment procedure (available in German only)