Blood pressure medicine sparks urgent recall alert

By ANGELA GREGORY

Thousands of New Zealanders are being asked to urgently return a popular brand of blood pressure medication and see their doctor.

The Ministry of Health is urging people using Felo ER to see their GPs as the medicine is being recalled by Auckland distributor Pacific Pharmaceuticals Ltd.

Felo ER, which contains the active ingredient felodipine, is used for the treatment of high blood pressure or stable angina and patients will need to be prescribed an alternative treatment.

The patient-level recall comes after concerns were raised about the validity of studies that led to its New Zealand registration.

The ministry received new information in September questioning the effectiveness of the medicine taken by about 50,000 New Zealanders, and approved for use in February 2000.

A pharmacist, who did not want to be named, told the Herald yesterday that the ministry's medicines safety authority (Medsafe) should have acted faster.

Dr Stewart Jessamine, spokesman for Medsafe, said it had in September faxed a written request to the German Regulatory Authority asking for more information. But the reply highlighting deficiencies in quality control and quality assurance in a study on the drug was sent to a Medsafe employee who was on leave. Officials did not receive the report until October 18.

Medsafe then advised Pacific Pharmaceuticals of its concerns as the study had been used to support the application to register Felo ER as a new medicine in New Zealand. Dr Jessamine said Medsafe's review of the documents from the German authority showed quality failures in crucial clinical areas such that the bioequivalence studies could not be regarded as accurate and should be discarded.

"Without these studies there is no compelling evidence for the effectiveness of Felo ER, and there is concern that it may not offer the same degree of protection from the complications of high blood pressure and angina as other brands of felodipine."

Felo ER is manufactured in Europe by Siegfried Ltd, which has commissioned new studies to be completed early next year.

Dr Jessamine said that until Medsafe had assessed that data, Felo ER would not be sold here.

He noted there was no evidence from adverse reactions monitoring in Germany and New Zealand that Felo ER was harmful. Patients should continue taking Felo ER until they could change to another treatment because the risks of untreated angina and/or high blood pressure were greater than the risks of continuing treatment.

Pacific Pharmaceuticals would reimburse doctors for one GP visit for each patient in relation to the recall.

Unused tablets should be given to pharmacists when patients picked up their replacement medicine.

Pacific Pharmaceuticals managing director John Kemp said: "GPs should transfer their patients to another calcium channel blocking agent or some other form of treatment appropriate for their underlying medical conditions.

"Medsafe licensed Felo ER based on the same Swiss studies that we had seen. We are confident that all supplies of Felo ER will be out of circulation by the end of the month."

A patient advice number, 0800 18 18 16, has been set up by Pacific Pharmaceuticals Ltd, and will operate from 7am today.

Further reading
nzherald.co.nz/health