Around 500 Irish patients may have been treated with a medicine that could have been up to 50 per cent stronger than it should have been, the Irish Medicines Board (IMB) said yesterday.
The medicine is called Clexane and is used in the treatment of blood disorders such as deep vein thrombosis. Some 30 batches of the product have now been recalled in 58 countries worldwide. One batch is being recalled in the Republic and five are being recalled in Britain.
The batch that was sent to the Republic was issued to 46 hospitals and 12 pharmacies across the State.
The IMB said the manufacturer, Sanofi-Aventis, alerted the IMB on Thursday evening last about a possible problem with one batch of the product sent to the Republic from France.
Over-concentration of the active medicinal substance in Clexane "has the potential to cause significant adverse reactions including an increased risk of serious bleeding", the IMB said.
While approximately 500 Irish patients may have been treated with the product since last November, the IMB said only one patient had shown an adverse reaction. This patient suffered "irregular bleeding".
Any patient who may have syringes from the affected batch in their home has now been urged by the IMB not to use them.
"You should, as soon as possible, go to your local doctor for further advice and treatment. The IMB can confirm that additional batches of Clexane are available in the marketplace," the IMB said.
The product is issued in syringes and the batch of Clexane syringes being recalled is of 80mg/0.8ml strength, it bears an expiry date of 09/07 and its batch/lot number is 28043.
The IMB said the product was being recalled "due to the potential for an over-concentration of up to 50 per cent of the active medicinal substance, enoxaparin, in a number of syringes".
It added that the batch entered the distribution chain in Ireland on November 22nd, 2005, and was distributed to 46 hospitals and 12 retail pharmacies.
All hospitals and retail pharmacies have been contacted to notify them of the recall.