ONE of the biggest international pharmaceutical companies operating in Ireland is being officially investigated over failures and delays in reporting details of side effects of its products, including one case where a patient died.
The Sunday Tribune has learned that last June a patient died following an adverse reaction to taking a drug known as Clexane, an anti-clotting agent manufactured by Aventis Ltd which is based at Citywest.
However, it is understood that the company did not inform the state regulators, the Irish Medicines Board (IMB), of the event until January this year. Highly-placed sources said that the IMB first learned of the death on foot of a report from a coroner.
It is understood that the IMB expressed its strong concern to Aventis over the reporting failures in the weeks after learning of the case. Informed sources said that the IMB was subsequently informed of a number of other suspected serious adverse reactions experienced by patients to drugs which had not been officially reported by the company.
In a statement this weekend, the IMB said that it was compulsory for product licence holders to inform any suspected serious adverse reactions of Irish origin within 15 days of first notification to any personnel within the company.
"Aventis Pharma Ltd did not conform to this obligation despite having received written warnings from the IMB to comply under both EU and national guidance and legislation.
"The IMB confirms that it has provided advice, support and guidance to assist the company to improve its reporting mechanism. However, the company continued to delay reporting suspected adverse reactions appropriately ."The IMB can confirm that it has reported the company to its Advisory Committee and its board is now undertaking a widespread investigation of all pharmcovigilance procedures and processes at the Irish offices of Aventis Pharma Ltd, " the IMB said.
Aventis Pharma told the Sunday Tribune this weekend that it was in discussions on pharmcovigilance procedures with the IMB.
"Aventis Pharma is cooperating fully with the IMB and is taking urgent action to ensure that company procedures are fully compliant".