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news.Janssen-Cilag International has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended suspension of the marketing authorization for Ionsys, indicated for the management of acute moderate to severe post-operative pain for use in a hospital setting only.
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Janssen-Cilag recalled Ionsys in the European Union (EU) in September 2008, as a precautionary measure following identification of corrosion in a component of the system in one lot of the product. This corrosion could lead to self-activation of the system resulting in the delivery of doses of fentanyl to the patient that had not been requested. As a result, Ionsys is not currently available for use anywhere in the EU, the company said.
The Committee for Medicinal Products for Human Use (CHMP) has concluded that until the current defect is understood, corrected and the company demonstrates the quality of the product, the benefits of Ionsys no longer outweigh its risks, and has recommended that the marketing authorization should be suspended across the EU. Lifting of the suspension will be conditional on the company resolving the issues identified by the European Medicines Agency.
The company said that it continues to analyze the root cause of the defect found in one lot of Ionsys. Part of the company’s ongoing analysis is to determine what initiated corrosion observed in the systems that were recalled.