Recall of blood pressure drug after dosage error on label

THOUSANDS of packets of a popular blood pressure drug have been recalled amid fears that some patients may have been receiving dangerous levels of medication due to a labelling error.

Dilzem XL, marketed by the Elan Corporation, was yesterday the subject of a warning issued by the Irish Medicines Board, which said some patients may have received higher-than-prescribed doses due to the error.

The drug, which contains an ingredient called diltiazem hydrochloride, is a prescription-only medication used to treat most blood pressure conditions, such as angina or hypertension.

An IMB spokeswoman said an overdose of the medication would likely result in a lowering of blood pressure and heart rate.

Tim Delaney, head of Tallaght Hospital’s pharmacy department, said an overdose would not be fatal but could cause problems if it reduced significantly a person’s blood pressure.

“An overdose of it could cause your blood pressure to drop significantly. The most likely problem with that is you would feel faint, which would be dangerous if you were driving a car or something like that,” he said.

All pharmacies nationally received a recall letter last week but the IMB was concerned that patients could still have the faulty batch.

The IMB warning, in national newspaper advertisements yesterday, was issued to all patients and health care professionals who may have been using the drug. It advises users that packages of Dilzem 240mg and 180mg capsules bought since August 22 should be returned to a pharmacist for checking, and if necessary, replacement.

The packaging error relates to the strength of the capsules as printed on the blister strips in an unspecified number of packs.

Usually the IMB issues packaging warnings only to doctors and pharmacists, but on this occasion it was felt that the public should also be informed, an IMB spokeswoman said.

A spokesman for Elan in New York said the company had acted as soon as it was realised there was a problem here and in Britain. Elan said only 60 packets of a product run of 33,000 were affected.

“We acted immediately when we heard there was a problem, and we have traced all of the packets involved except for five,” the spokesman said.

“We don’t have a date for when the problem was discovered, but it was discovered by a patient in the UK who noticed his capsules were different to those he had received previously,” he said.

Elan was yesterday unable to specify how many packets of Dilzem it sold in Ireland but said the British and Irish markets combined were worth between £600,000 and £700,000. Of the 30 reports of quality defects to the IMB last year, one was considered serious enough to merit a batch recall.