EMA issue restricted indication for d4T (stavudine)
European Medicines Agency (EMA)
The European Medicines Agency has completed a review of Zerit as part of the procedure for the renewal of the medicines marketing authorisation.
The Agencys Committee for Medicinal Products for Human Use (CHMP) has recommended that the marketing authorisation for Zerit should be renewed but that the use of the medicine should be severely restricted in both adults and children.
In this context:
- Prescribers are reminded of the severe side effects seen with Zerit and should only use the medicine when other appropriate treatments are not available;
- Patients being treated with Zerit should be assessed frequently and switched to appropriate alternatives as soon as possible;
- Prescribers should consult the updated prescribing information and the communication letter that will be sent to them for more information;
- Patients should continue reporting any possible side effects to their doctor and should contact their doctor or pharmacist with any questions they have concerning their treatment.
Source: European Medicines Agency (EMA) (21.02.2011)
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 February 2011
A questions and answers document referring to this matter can be found in the following link: