The Parliamentary Secretariat for Health said this evening that there was no harm to patients from the continued use of Amlodipine 5 mg tablets distributed from Government pharmacies and from pharmacies in the Pharmacy of your Choice scheme.
It explained that last Monday, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, issued a Class 2 Drug Alert on a number of batches of medicinal products manufactured in the UK by Wockhardt UK Ltd on behalf of Jubilant Pharmaceuticals NV. A Class 2 alert required all authorities to take action within 48 hours. This recall was classified as class 2 up to pharmacy level in view of general problems with manufacturing practice identified by the inspectors in the UK at the manufacturing site. These manufacturing deficiencies did not in any way compromise patient safety.
"It was determined that Amlodipine 5mg tablets from these batches had been procured by the Government Health Procurement Services and distributed in Malta and Gozo to health centres, hospitals and the Pharmacy of Your Choice. In view of this situation, Amlodipine 5mg tablets were recalled from all pharmacies and stores on the 30th June 2009 in accordance with the instructions of the Malta Medicines Authority. This action is exactly similar to the action taken by the UK authorities," the secretariat said.
"There was really no need to issue any public statement because as determined by the UK Health Authorities, there is no harm to patients from the continued use of these tablets. If there was a risk to patient safety the local health authorities would have taken the necessary action to inform patients. Moreover it was considered that unnecessarily alarming patients would do them more harm than good. It is imperative that patients who are taking amlodipine do not stop their medication even if the stock they have available is of this particular brand," the secretariat explained.
It appealed to all concerned to avoid making public statements prior to checking the facts because this could only cause confusion to patients and unnecessary alarm.
Amlodipine 5mg tables are used mostly to treat high blood pressure.