Discovery of new nitrosamine contamination in tuberculosis drugs: Swissmedic pushes clarification ahead

Traces of the nitrosamine MeNP discovered in rifampicin


The Swissmedic laboratory has discovered traces of the nitrosamine MeNP in preparations containing the active substance rifampicin. There is no immediate risk to patient health.

Swissmedic investigated in the last weeks the presence of a new nitrosamine impurity, 1-nitroso-4 methyl piperazine (MeNP), in some batches of active substances and finished products used in Rifampicin medicines sold in Switzerland

MeNP was detected in all products on the Swiss market and a temporary limit has been defined.

Since Rifampicin is an essential first-line treatment for tuberculosis and other serious infections, the risk to patients from not taking their Rifampicine medicines far outweighs any potential risk from MeNP.

Patients currently taking medicinal products that contain rifampicin must on no account discontinue them without first consulting a doctor: to stop taking these medicines without prior consultation would pose a far greater risk to health than the possible risk presented by the reported impurities.

Swissmedic shared the results generated to partner agencies/entities like EMA and EDQM (OMCL Network).

Swissmedic, together with partner agencies and the authorisation holders concerned, are currently investigating the further risks.

As soon as any significant results are available, Swissmedic will issue updates on the situation through this communication channel.