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UPDATE 1-EU drugs agency recommends suspension of Octogam

Published 09/24/2010, 08:27 AM
Updated 09/24/2010, 08:32 AM

* EU agency recommends suspension of Octopharma's Octogam

* Recommends recall of all Octagam on market in Europe

* Could benefit suppliers such as Grifols, Baxter, CSL

(Updates with details, background, other suppliers)

LONDON, Sept 24 (Reuters) - European drugs regulators recommended on Friday that the license for Octopharma's immunoglobulin treatment Octogam be suspended and all Octagam currently on the market in Europe should be recalled.

The decision could benefit other suppliers of immunoglobulin products, including Baxter, CSL and Grifols.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed Octagam because Germany and Sweden had suspended the marketing authorisation of the medicines after an unexpected increase in reports of thromboembolic reactions, including stroke, heart attack and pulmonary embolism in patients receiving the medicine.

This increase is thought to be related to problems with the medicine's manufacturing process, it said.

Octagam is an intravenous solution used to strengthen immunity in patients with a weakened immune system, including people with primary immunodeficiency syndrome, or children born with acquired immune deficiency syndrome (AIDS).

It is also used in people with certain immune disorders such as idiopathic thrombocytopenic purpura (ITP) and in patients who have had a bone marrow transplant.

"As the medicine will no longer be made available, the agency recommends that doctors should stop using Octagam and should switch their patients to the most appropriate alternative treatment," EMA said.

Spanish drugmaker Grifols said on Thursday it would be able to meet hospitals' increased need for intravenous immunoglobulin products since Octapharma's products had been pulled from several European markets. (Reporting by Kate Kelland; Editing by David Holmes)

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