The European Medicines Agency has recommended that all marketing authorisations for human normal immunoglobulin Octagam be suspended and that the drug be recalled.
The drug, produced by Octapharma, is an intravenous solution used to strengthen the body’s immune system.
The recommendation was made following marketing authorisation suspensions in Germany and Sweden, enacted after an unexpected increase in reports of thromboembolic reactions to the drug, including stroke, myocardial infarction and pulmonary embolism.
The agency added that doctors should stop using Octagam and should switch their patients to the most appropriate alternative treatment.
The recommendation will now be forwarded to the European Commission for the adoption of a binding decision.
The suspension would remain in place until the marketing authorisation holder has rectified the problem.
