Safety Information

Early Warning System - Alert Communication

Consumer Level Recall – Apo-Primidone 250mg tablets

18 April 2018

Products Affected
Information for consumers and caregivers
Information for healthcare professionals
What actions are Medsafe taking?
How to report adverse events
Further information

Description

Apotex NZ Limited is recalling one batch of Apo-Primidone 250mg tablets because they contain lead. The amount of lead is above safe level if more than 2 tablets are taken each day.

Primidone is an anti-epileptic medicine used to control seizures.

Products Affected

The product is: Apo-Primidone 250mg tablet
Batch Number: MT4041

Apo-Primidone 250mg tablet


 

Information for consumers and caregivers

  • Please continue taking your Apo-Primidone tablets. Stopping Primidone tablets suddenly can cause serious problems, including seizures which may not stop.

  • As soon as possible, return to your pharmacy with your remaining tablets. The pharmacist will give you a replacement from an unaffected batch. The replacement will be free.

  • Not all batches of this medicine contain lead

  • Make an appointment to see your doctor if you are taking Primidone.

  • This appointment and any blood tests will be free.

  • Your pharmacist/general practice will give you a letter which contains more information.

  • Contact Apotex NZ Ltd by calling (09) 444 2073 if you have questions about this recall.

  • Report any adverse events to a medicine by calling the Centre for Adverse Reactions Monitoring (CARM) toll-free at 0800 466 678 or by reporting online at https://nzphvc.otago.ac.nz/report

  • More information about lead can be found on the Ministry of Health’s website at www.health.govt.nz/your-health/conditions-and-treatments/diseases-and-illnesses/lead-poisoning .

 

Information for healthcare professionals

  • This recall only applies to Apo-Primidone 250mg batch MT4041.

  • Patients should be advised that they should continue to take Primidone tablets. Stopping Primidone tablets suddenly can cause serious problems, including seizures which may not stop.

  • Replacement stock from an unaffected batch is available.

  • Apotex is instructing consumers to return Apo-Primidone tablets to their pharmacy for a free replacement.

  • Pharmacies have been advised to contact all patients who have been dispensed Apo-Primidone 250mg tablets using stock purchased from wholesalers since 20 December 2016 for a free replacement.

  • A patient letter which outlines the nature of the issue, and contains vouchers for payment for any general practice visit relating to this issue and any subsequent blood testing that the GP considers necessary, is being sent to pharmacies and general practices by Apotex.

  • Permissible daily exposure (PDE) of lead is 5 micrograms/day. (www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm371025.pdf).

  • Lead consumed in excessive amounts poses serious health risks because it may accumulate in vital organs of the body. It can be harmful to people of all ages, but the risk is highest for unborn babies, infants and young children (under five years of age).  While lead can affect nearly every bodily system, its effects depend upon the amount and duration of lead exposure and age.

  • Symptoms of lead poisoning can include abdominal pain, vomiting, lack of energy, irritability, weakness, behaviour or mood changes, delirium, seizures, and coma.  However, infants, young children and the developing fetus can be affected by chronic exposure to amounts of lead that may not result in obvious symptoms of lead poisoning.  A child with lead poisoning may not look or act sick.

  • Contact Apotex NZ Ltd by calling (09) 444 2073 if you have questions about this recall.

  • Report any adverse events to a medicine by calling the Centre for Adverse Reactions Monitoring (CARM) toll-free at 0800 466 678 or by reporting online at https://nzphvc.otago.ac.nz/report

What actions are Medsafe taking?

Medsafe is working with Apotex to ensure an efficient recall and will review any adverse events that may be reported.

How to report adverse events

Phone + 64 3 479 7247 to speak to a Medical Assessor at the Centre for Adverse Reactions Monitoring (CARM)
  From your iPhone using the ADR online app
Online Submit a report to CARM
Prescribers can submit using the online reporting tool available in patient management software
Yellow Card A completed Yellow card can be submitted to CARM via email, fax or mail
Email carmnz@otago.ac.nz
Fax +64 3 479 7150

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.