Media Release
17 September 2009
Import of Apotex products under close monitoring
This is an update to our release on Monday 14 September.
The Ministry of Health’s drug regulatory arm Medsafe has negotiated an agreement with pharmaceutical manufacturer Apotex to temporarily restrict importation of medicines produced by Apotex at its two manufacturing sites in Toronto, Canada.
This follows a similar move in the United States last week, where further imports of Apotex medicines manufactured from these two sites has ceased. Apotex has also voluntarily recalled 40 medicines from the US market and three from the Canadian market. No batches of the medicines recalled in the US and Canada are available in New Zealand.
The agreement to temporarily restrict imports in New Zealand is effective today. It has come about after concerns were identified by the US Food and Drug Administration (FDA) when they found deviations from accepted manufacturing processes at two Apotex manufacturing plants in Toronto, Canada.
Medsafe Group Manager Dr Stewart Jessamine says the temporary restriction on imports is a precautionary measure which will remain in place until Medsafe is satisfied that Apotex had improved its manufacturing practices. "At this point, there is no reason for people to be concerned about taking any medicines manufactured by Apotex. There is no suggestion that people have been put at risk by taking any medicines made at any Apotex plants," Dr Jessamine said. “The issue that has been identified relates to the assurance of quality manufacture at the Canadian plants.”
Apotex makes and markets a wide range of medicines which are supplied to 115 countries worldwide. Medsafe has been working closely with PHARMAC, New Zealand's pharmaceutical funding and purchasing agency, to identify which Apotex medicines are available in New Zealand. PHARMAC funds 30 medicines supplied by Apotex, of which 20 are made at the two sites.
PHARMAC medical director, Peter Moodie, said Apotex products are widely used in New Zealand as they are in many countries and PHARMAC was keen to ensure continued supply of high quality medicines for New Zealanders.
“As a precaution, PHARMAC has begun discussions with other companies to ensure that future supply requirements can be met in the event that the import restriction is required for longer than expected.
“Our first priority is to ensure New Zealanders can have ongoing access to their medicines,” Dr Moodie said
Since the cessation of imports to the US last week, Medsafe has been in discussions with the FDA, Health Canada, PHARMAC and Apotex to obtain up to date, accurate information about the international situation. Health Canada is currently auditing the two affected Apotex sites in Etobicoke and Weston. Due to the size and scale of Apotex's operations in Toronto, the site visits alone will take at least a month. The audit is being carefully followed by medicine regulatory authorities around the world.
"We will continue to actively monitor this situation and will inform healthcare professionals and consumers if the situation changes significantly", he said.
For more information view the questions and answers below,
or contact:
Simon England
Communications Manager
PHARMAC
Phone 021 863 342
or Karalyn van Deursen
Senior Media Advisor
Ministry of Health
Phone 021 832 459
ENDS
Questions and answers
What is the issue?
Medsafe was notified by Apotex on 7 September 2009 of concerns with two manufacturing plants owned by Apotex. The Apotex notification follows an FDA audit that found deviations from accepted manufacturing processes at two of Apotex’s manufacturing plants based in Toronto (Weston, Etobicoke).
The FDA’s concerns relate to deficiencies in quality assurance processes and in documentation relating to the manufacture of medicines. As a result the FDA stopped the import of product manufactured at the two sites into the US.
Who are Apotex?
Apotex is a Canadian-based company that makes and markets medicines. Apotex supplies medicines to 115 countries including New Zealand, Australia, Canada, US, and the UK. It has sales of over Canadian $1 billion annually.
What action is Medsafe taking?
Medsafe is working closely with other regulatory authorities and Apotex to obtain assurance that issues identified in the FDA audit have been resolved by Apotex.
In the interim, Apotex has agreed to import restrictions of medicines manufactured from the two affected sites into New Zealand.
Medsafe is working closely with Apotex and PHARMAC to ensure the import restrictions do not result in any medicine supply shortages.
What action are other countries taking?
Apotex has ceased the further export of medicines manufactured from both of the affected plants into the United States. Apotex has also voluntarily recalled 40 batches of medicines from the US market.
In Canada, Health Canada is conducting an audit of the sites concerned. The sites continue to supply medicines to Canada. Apotex has voluntarily recalled three batches of medicines.
Information provided to Medsafe indicates that no batches of medicines voluntarily recalled in US or Canada are available in New Zealand.
Medsafe remains in regular contact with international regulatory authorities to monitor any action being taken overseas.
What Apotex products made at either of the two affected sites are available in New Zealand?
See the table below in Appendix 1 for the list of products manufactured by the two affected sites that are funded by PHARMAC or available over the counter in New Zealand
Advice for Patients
Should I stop taking my medicine if it is made by Apotex?
No. There is no indication that patients have experienced problems from using Apotex medicines. In addition, the batches of medicines voluntarily recalled in the US and Canada are not available in New Zealand.
It is important that you do not stop taking your medicine as abruptly stopping some medicines can be dangerous.
Do I need to see my doctor?
No, you should keep taking your medication as prescribed. Medsafe and PHARMAC will be communicating with healthcare professionals to keep them informed of further developments as necessary. If you are concerned talk to your doctor next time you visit.
If the situation changes, Medsafe and PHARMAC will make a public announcement.
Who can I contact for further information?
You should contact a healthcare professional such as your GP or pharmacist. For general information about the medicines affected check the Ministry of Health website http://www.moh.govt.nz or call Healthline on 0800 611 116. Healthline is open 24 hours a day seven days a week.
Appendix 1 – List of products manufactured by the two affected sites that are funded by PHARMAC or available over the counter in New Zealand
A list of all medicines manufactured at the two affected sites that have consent for distribution in New Zealand is available on the Medsafe website at: http://www.medsafe.govt.nz.
1. Medicines funded
| Product | Use |
| Allopurinol | Gout |
| Amlodipine | Blood pressure |
| Bromocriptine | Parkinson’s disease |
| Captopril | Hypertension |
| Cimetidine | Heartburn and peptic ulcers |
| Clopidigrel | Blood clots |
| Diclofenac | Inflammation and pain |
| Doxazosin | Blood pressure |
| Gliclazide | Type 2 diabetes |
| Moclobemide | Depression |
| Nadolol | Blood pressure and migranes |
| Oxybutynin | Urinary and bladder difficulties |
| Prazosin | Blood pressure |
| Prednisone | Allergic disorders, ulcerative colitis, psoriasis and arthritis |
| Primidone | Epilepsy |
| Selegiline | Parkinson’s disease |
| Terazosin | Blood pressure |
| Terbinafine | Skin infections |
| Timolol maleate | Blood pressure and glaucoma |
| Zopiclone | Insomnia |
2. Over-the-counter medicines
| Product | Use |
| Apo-Diclo | Pain and inflammation |
| Apo-Cetirizine | Allergies/hayfever |
| Apo-Famotidine | Heartburn and peptic ulcers |
| Apo-Ibuprofen | Pain and inflammation |
| Ibucare (ibuprofen) | Pain and inflammation |
| Apo-Loperamine | Diarrhoea |
| Apo-Loratadine | Allergies/hay fever |
| Apo-Ranitidine | Heartburn and peptic ulcers |