Safety of teriflunomide. Practice based on long-term data obtained from clinical trials and real-world data. Expert opinion Consensus
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Abstract
Adverse events are part of the drug use and they should always be taken into account. The risk should be assessed individually. All registered drugs have advantageous profile of benefits to risk ratio. It is still essential to monitor drug safety after their registration. The system of safety monitoring is based on requirements from pharmaceutical companies and spontaneous reporting of all the observed problems associated with the drug’s use both by professional health care providers and patients, and their families. Teriflunomide was registered by European Medicine Agency in 2013 and since that time no unexpected and serious adverse events were noted, and the safety profile in the so-called real-world observations was compatible with results from clinical trials. In expert statement current data on teriflunomide safety was presented including such area of special monitoring such as safety in women of childbearing potential.
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