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Death leads to recall of batch of Takeda's Rienso in Switzerland

Marketing partner Amag also reports three other hypersensitivity reactions

Death leads to recall of batch of Takeda's Rienso in SwitzerlandTakeda has recalled a batch of its anaemia medicine Rienso (ferumoxytol) in Switzerland following four reports of hypersensitivity reactions, including one death.

Amag Pharmaceuticals – Takeda's marketing partner in the country – announced the recall in a regulatory filing on Tuesday, in which it said “[t]he batch was only distributed to and sold in Switzerland and the recall is limited to the specific batch and specifically Switzerland”.

Further details of the fatality or other reactions were not given, although the filing did say IV irons, such as Rienso, may cause serious hypersensitivity reactions, including anaphylactic reaction.

As reported by Reuters, Amag's shares were down about 5 per cent following the recall announcement.

Both Amag and Takeda are now investigating the Swiss batch of Rienso, while the introduction of new batches will depend on approval by Swiss health regulator Swissmedic.

Swissmedic also confirmed the batch was distributed solely in Switzerland, and the recall would not affect other countries.

Rienso is sold as Feraheme in the US and Canada, where Takeda is the exclusive distributor.

This isn't the first recall that has affected Takeda this year, with the company forced to issue a US withdrawal of Omontys (peginesatide) – a medicine to treat anaemia caused by chronic kidney disease – after several deaths were reported due to serious hypersensitivity reactions within 30 minutes following the first intravenous dose of treatment.

Takeda was also given a six-month suspension from its duties as vice president of the Japan Pharmaceutical Manufacturers Association (JPMA) as a result of a labelling error for vitamin supplement Alinamin F5, which led to a recall of a batch of the product.

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23rd May 2013

From: Sales, Healthcare

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