EMA: Inductos to be suspended in the EU
Suspension will remain until manufacturing issues are resolved
The European Medicines Agency (EMA) has recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures. Inductos will remain suspended until issues with the manufacturing site for one of the components of Inductos (an absorbable sponge) are resolved.
EMA started a review of Inductos following an inspection by Dutch and Spanish authorities which found the manufacturing site of the absorbable sponge to be non-compliant with manufacturing requirements. The inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges.
Although there is no indication of risk to patients linked to the inspection findings, EMA’s Committee for Medicinal Products for Human Use (CHMP) considered that the quality of Inductos cannot be assured with the current manufacturing process. The CHMP therefore concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed.
The recommendation will be sent to the European Commission for a final legally binding decision.
Information for patients and healthcare professionals
- Problems have been identified with the way the absorbable sponge in Inductos is manufactured.
- Although there is no indication of risk to patients, Inductos has been suspended and will no longer be available in the EU until issues with the manufacturing site for the absorbable sponge are solved.
- There are alternative treatments available in the EU.
- Patients who have any questions or concerns should speak to their healthcare professional.
Posted on the EMA website on 23 October 2015