Revised: 14 May 2013
Publications
Media Releases for 2005
16 December 2005
Medsafe looks to revise fees for the evaluation and registration of medicines
The agency responsible for regulating medicines is consulting on increasing its fees from 1 July next year for the first time in well over a decade, and in some cases for the first time in 28-years.
The increases reflect the rising costs of regulation as demands on Medsafe to evaluate, audit and monitor the safety of medicines and their manufacture increase.
For instance an application to Medsafe for a new medicine (involving a new chemical entity) typically involves the evaluation of a quarter of a tonne of paperwork.
Under the Medicines Act fees are levied on applications to licence medicine manufacturers and to approve new medicines and clinical trials. Fees are also levied under the Misuse of Drugs Act for applications for licences to, for example, import and export controlled drugs.
Medsafe's Principal Technical Specialist, Dr Stewart Jessamine, says this is the first time since 1977 that fees under the Misuse of Drugs Act have been revised. Fees under the Medicines Act have not been increased since they were first introduced 15 years ago.
"The fees in most cases have been falling well short of covering the actual costs of the complex work related to applications for licences and approval of medicines," Dr Jessamine says.
It is important for New Zealand to meet international best practice standards for the regulation of medicines and also to maintain specialist technical expertise in this area.
The growing gap between the cost of evaluating medicine safety and the amount recovered in fees has meant that approvals for some medicines have been taking as long as three years to process.
Dr Jessamine says it would be tempting to predict that the fee increases will mean shorter times for approving medicines. While that will be true in the long term as capability is strengthened within Medsafe it will be at least a year or 18 months before any improvement can be demonstrated.
"While in most cases the fees for high risk complex activities are going to increase significantly, it is important to note that they still come well under other developed countries, including Britain, the United Sates of America and Australia."
It's important to remember that the work involved in ensuring medicine safety in New Zealand is no less demanding, or important than it is in other overseas jurisdictions, Dr Jessamine says.
Medsafe will begin consultation this week with organisations and individuals affected by the fee increases and feedback from the consultation will be considered before finalising the new fees.
A copy of the consultation paper is available on the Medsafe website.
ENDS
Dr Stewart Jessamine will be available for media interview between 1 and 3pm on Friday 16 December. For further details please contact:
Lucy Taylor
Media Advisor
Ministry of Health
04 496 2067
027 207 1406
29 April 2005
Stringent Conditions for COX-2 Inhibitors
The class of medicines known as COX-2 inhibitors will stay on the market, but with considerably stronger warnings for their use and the requirements for pharmaceutical companies to collect and report information on usage.
Pharmaceutical companies will also have to provide Medsafe with additional safety information as it becomes available.
The Ministry is also seeking to extend, until further notice, the voluntary ban by pharmaceutical companies on promoting these products, some of which have been previously advertised on television.
Recommendations made by the Medicines Adverse Reactions Committee (MARC), and accepted by the Ministry of Health, end months of uncertainty for patients. A review of the cardiovascular safety of the COX-2 inhibitors was begun in October 2004 after Vioxx (rofecoxib), one of six COX-2 inhibitors marketed in New Zealand, was withdrawn after international findings that its use was associated with an increased risk of heart attacks and strokes.
In February this year the Ministry warned against using COX-2 inhibitors in patients at high risk of heart attacks or strokes. High risk patients include those with a previous history of heart attack or stroke; those with diabetes, high blood pressure, high cholesterol levels or patients who smoke.
In early April a second COX-2 inhibitor, Bextra (valdecoxib), was voluntarily withdrawn by its manufacturer due to concerns about an increased risk of serious skin reactions. It is anticipated that a decision regarding the most appropriate strategy to manage the risk associated with Bextra (valdecoxib) will be made after the MARC meeting in June 2005.
"The advice which we are issuing today, based on the MARC recommendations, reflects our earlier view that an increased risk of heart attacks and strokes can occur with all COX-2 inhibitors," Ministry spokesman Dr Stewart Jessamine said.
"However, we accept the very strong arguments from some patients and prescribers that for some people these medicines are the best treatment option.
"Therefore, we are allowing continued use but with restrictions to ensure that they are used mainly by those patients for whom they offer the most benefit and the least risk.
"This approach puts us in line with our European counterparts, the European Medicines Evaluation Agency, and pretty close to Australia," Dr Jessamine, Principal Technical Specialist with Medsafe, said.
"Chief amongst our requirements for allowing continued marketing of these medicines in New Zealand is that companies make the warnings in the consumer and prescriber information stronger and fuller.
"We believe that giving doctors and patients enough information will allow both to weigh up the risks and benefits for each individual patient and make a fully informed decision."
Dr Jessamine said Medsafe has already faxed the key information to doctors and pharmacies today.
"We are also advising both the Royal Australasian College of Surgeons and the Australian and New Zealand College of Anaesthetists that it is crucial that their members carry out a full risk-benefit analysis for all patients, and that they fully inform patients of the risks and benefits before routinely using COX-2 inhibitors for relief of pain and inflammation associated with an operation."
11 April 2005
Pfizer voluntarily withdraws Bextra from New Zealand market
Pharmaceutical company Pfizer is voluntarily withdrawing the COX-2 medicine Bextra from the New Zealand market following a request from Medsafe to suspend distribution and marketing, and will recall supplies of Bextra progressively from wholesale and pharmacy shelves over the next few days.
Medsafe Principal Technical Specialist Dr Stewart Jessamine said Pfizer today informed Medsafe it would be voluntarily withdrawing Bextra (valdecoxib), following similar withdrawals in the US, Europe and Canada.
Along with other COX-2 inhibitors, the safety of Bextra is already under review due to concerns about possible cardiovascular risk, (heart attack or stroke), when taking these products.
In the past week the United States Food and Drug Administration (FDA) has expressed the opinion that the risks of using Bextra outweigh its benefits because Bextra has similar cardiovascular risks as other COX-2 medicines and a higher risk of serious adverse skin reactions. Following this announcement Medsafe, along with other regulators, asked Pfizer to voluntarily suspend distribution and marketing Bextra from the market to allow further review of the risk:benefit of this product.
The voluntary withdrawal will commence this week and will remain in place at least until after the Medicines Adverse Reaction Committee (MARC) reviews data on serious cutaneous adverse reactions associated with use of Bextra at its June meeting. Medsafe will consider the MARC's recommendations about Bextra and skin reactions before it makes its final decision.
Dr Jessamine said "The MARC remain very concerned about the safety of the COX-2 inhibitors and stand by its earlier advice on this group of medicines. Due to the increased level of concern about Bextra, Medsafe is advising people taking this medicine to make an appointment to see their doctor at their own convenience to discuss stopping Bextra and changing to another treatment option while awaiting the outcome of this extended review.''
Medsafe's final decision on the cardiovascular safety of the class of COX-2 inhibitors, to which Bextra belongs, should be known later this month.
Background information
Pfizer comment on the US withdrawal of Bextra: http://www.bextra.com/
FDA announcement of US withdrawal of Bextra: http://www.fda.gov/bbs/topics/news/2005/NEW01171.html
Questions and answers about Bextra from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA): http://www.mhra.gov.uk/news/bextraqanda.pdf
Medsafe advice to Doctors and Pharmacists February 2005.
22 February 2005
Ministry of Health Issues Strong Warning on COX-2 Inhibitors
THE MINISTRY of Health says the increased risk of heart attack and stroke (cardiovascular events) outweighs the benefits of COX-2 inhibitors for the general population.
It is advising people who are at high risk of cardiovascular events to see their doctor to discuss stopping treatment with COX-2 inhibitors immediately. Others taking the medicines but not at high risk should discuss cessation of the COX-2 inhibitor at their next scheduled GP appointment and consider alternative treatment options.
"We don't have enough information yet to quantify the risk associated with each of the five Cox-2 inhibitors currently available in New Zealand," Ministry spokesman Dr Stewart Jessamine said today.
"But our preliminary conclusions are that all COX-2 inhibitors may increase the risk of developing a heart attack or stroke to some degree in some patients."
Dr Jessamine said those at high risk were patients with a previous history of heart attack or stroke; a strong family history of heart disease; a history of diabetes, smoking, hypertension, or who are on treatment for high cholesterol.
Dr Jessamine, Principal Medical Advisor with Medsafe, the Ministry of Health's medicines regulator, said Medsafe had reviewed the safety of all COX-2 inhibitor medicines. The review followed last October's recall of one of these medicines, Vioxx, after international findings that its use was associated with an increased risk of heart attack and stroke.
The Medsafe review considered data on the safety and efficacy of each COX-2 inhibitor from the published literature and that submitted by the pharmaceutical industry in support of their products.
"Unfortunately despite reviewing extensive amounts of data, there is still not enough information to quantify the risk associated with each of these medicines, or to determine which patients are at increased risk or whether aspects of treatment such as dose or duration of use affect the degree of risk," Dr Jessamine said.
"While there is uncertainty about the degree of risk posed by each medicine, on the basis of the evidence available to date Medsafe's opinion is that the possible increased risk of heart attack and stroke outweigh the benefits of COX-2 inhibitors for the general population. At least 60,000 people are estimated to have taken a COX-2 inhibitor in the past year, however, Medsafe do not have prescribing data and so cannot determine the actual number of patients using these medicines. "
Medsafe is seeking further information from the pharmaceutical industry and the published literature before making a final decision on the safety of these products. The Medicines Adverse Reactions Committee will discuss Medsafe's preliminary conclusions and any further data published or submitted on the safety of the COX-2 inhibitors at its March 2005 meeting. Any FDA or European regulatory agency findings made in the interim will also be considered at this meeting.
"To reiterate: in the interim our advice is this," Dr Jessamine said.
- Patients who are being treated with a COX-2 inhibitor and who are at high risk of developing a cardiovascular event such as: a previous history of heart attack or stroke, who have a strong family history of heart disease, or have a history of diabetes, smoking, hypertension, or who are on treatment for high cholesterol should see their doctor to discuss stopping treatment immediately.
- All other patients being treated with COX-2 inhibitor medicines should discuss alternative treatment options with their GP at their next scheduled appointment.
ENDS
For more information contact:
Frances Ross
Chief Media Advisor
Ministry of Health
Tel: 04 496 2202 or 021 512 898
BACKGROUND MATERIAL
What are COX-2 inhibitors?
COX-2 inhibitors are a relatively new type of anti-inflammatory medicine used to relieve pain, swelling and inflammation. Pain and inflammation are mediated in the body by a number of signal chemicals; several of these chemicals are created by the action of the enzyme cyclo-oxygenase (COX) on the chemical arachidonic acid. There are two forms of the COX enzyme, COX-1 and COX-2. Different proportions of COX are found in different tissues, and inhibiting this enzyme produces different effects on each tissue where the enzyme is blocked.
Older anti-inflammatory agents predominately block the COX-1 form of the enzyme and in addition to producing relief from pain and inflammation, can cause stomach ulceration by blocking the effect COX-1 action has in producing protective mucous in the stomach. The newer COX-2 medications produce a lesser effect on COX-1 and therefore are thought to be more specific for pain and inflammation and less likely to cause gastrointestinal side effects. The COX-2 inhibitor medicines listed below are approved for the treatment of arthritis and acute pain, and in the case of celecoxib as a treatment for a rare condition that causes polyps on the bowel.
Why do COX-2 inhibitors increase the risk of heart attacks or strokes?
COX-2 inhibition is thought to increase the risk of heart attacks and strokes through the changes it produces to substances called prostacyclins, prostaglandins and thromboxane. These three substances are involved in the initial stages of blood clotting and the body's response to blood clots. COX-2 inhibition upsets the balance between these substances, by increasing the levels of the substances that activate components of blood called platelets to form clots and decreasing the level of other substances that prevent platelet clot formation and respond to the creation of small clots on the walls of arteries. When blood clots lodge in the arteries of the heart, heart attacks can occur. Similarly, blood clots in the arteries of the brain may cause a stroke.
Why did Medsafe conduct a review of the COX-2 inhibitors?
Following the voluntary recall last October of the COX-2 inhibitor Vioxx due to the finding that use of this medicine was associated with an increased risk of developing a heart attack or stroke, Medsafe has been conducting a review of the safety of all COX-2 inhibitors medicines. This review has considered data on the safety and efficacy of each COX-2 inhibitor from the published literature and data submitted by the pharmaceutical companies that market COX-2 inhibitor products in New Zealand.
Can COX-2 inhibitors be stopped suddenly?
Unlike many other medicines, the COX-2 inhibitor medicines can be stopped suddenly without ill effect. However patients may need to take some other painkiller or anti-inflammatory medicine to manage the return of symptoms. A number of alternatives treatments are available. Medsafe has advised doctors to discuss the various alternatives with patients before starting other medicines. All General Practitioners should have recently received a publication from the Best Practice Advocacy Group (BPAC) describing options and strategies for managing pain and inflammation. This document includes advice on managing pain in patients with gastric ulcer disease.
Which COX-2 inhibitors are available in NZ?
Celecoxib (brand name: Celebrex)
Etoricoxib (brand name: Arcoxia)
Meloxicam (brand name: Mobic)
Parecoxib (brand name: Dynastat)
Valdecoxib (brand name: Bextra)
What alternative anti-inflammatory agents are available?
Alternative anti-inflammatory agents include:
Diclofenac (brand names: Apo-Diclofenac, Apo-Diclo SR, Voltaren)
Ibuprofen (brand names: I-Profen, Brufen, Brufen Retard)
Sulindac (brand names: Clinoril, Daclin)
Tiaprofenic acid (brand names: Surgam, Surgam SA)
Ketoprofen (brand names: Orudis, Oruvail)
Naproxen (brand names: Naxen, Naprosyn SR, Synflex)
Tenoxicam (brand names: Tilcotil)
Piroxicam (brand names: Piram D)
What is Medsafe doing next?
Medsafe is seeking further information from the published literature, other medicines regulators and the pharmaceutical companies who distribute COX-2 inhibitor medicines. The Medicines Adverse Reactions Committee will discuss this information at its next meeting in March 2005. Once this has occurred, Medsafe will make a final decision on the safety of the COX-2 inhibitors.
What are other countries doing?
The Australian Therapeutics Goods Administration, the European Medicines Agency and an advisory committee to the United States Food and Drug Administration have recently completed reviews of the safety of COX-2 inhibitors. All three agencies reached similar conclusions to Medsafe that increased cardiovascular risk is a class effect and is present in all COX-2 inhibitor medicines.
The preliminary advice issued by the Australian and European regulators however, differs from that proposed by Medsafe. The Food and Drug Administration are yet to make a statement on this issue. In Medsafe's opinion, the prescribing, funding and consumer environment in New Zealand differs from the Australian and European environments and warrants a more cautious approach.
For example of the six COX-2 inhibitors that have Ministerial consent to market in New Zealand, five are currently actively marketed and none are government-funded. Medsafe therefore has only limited information on the types or numbers of patients being prescribed these medicines. In Australia, while the same six medicines are approved for use, only three of the group are marketed, and two are government-funded. Prescribing data available to the TGA allows it to ascertain information on the numbers of patients using these medicines and the doses being prescribed.
In addition, direct-to-consumer advertising of prescription medicines is prohibited in both Australia and Europe.
Links to other material:
Europe:
EMEA announces regulatory action on COX-2 inhibitors - 17 Feb 2005
http://www.emea.eu.int/htms/hotpress/d6275705.htm
EMEA updated Questions and Answers on COX-2 inhibitors - 17 Feb 2005
http://www.emea.eu.int/pdfs/human/press/pr/6297805en.pdf
UK:
MHRA issues updated on advice of the safety of selective COX-2 inhibitors
- 17 Feb 2005
http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ddlcox2170205.pdf
New Zealand:
Minutes of Medsafe meeting with MARC Chair - 11 Feb 2005:
www.medsafe.govt.nz/Profs/adverse/MinutesCox2.asp
Australia:
TGA media statement - 10 Feb 2005
http://www.tga.gov.au/media/2005/050210_cox2.htm
Additional information for doctors and pharmacists - 14 Feb 2005
http://www.tga.gov.au/media/2005/050214_cox2.htm
18 February 2005
Ministry of Health welcomes internet pharmacy convictions
Ministry of Health welcomes internet pharmacy convictions
The Ministry of Health welcomes the convictions of a Dunedin company, Vanilla Limited, and its two shareholders in relation to the sale of prescription medicines over the internet in breach of the Medicines Act 1981.
The shareholders are Deborah Isabella Young, a Dunedin pharmacist and a former director of Vanilla Limited, and Stephen Alan Brentnall, the current sole director of the Dunedin company.
On January 31 this year in the Dunedin District Court, the three defendants entered pleas of guilty to a number of charges relating to an operation that involved the sale of prescription and other medicines via the internet to overseas purchasers. The medicines were being sent from New Zealand and routed through Fiji to destinations in Italy, the Netherlands, the United Kingdom, Singapore, Canada and the United States. The medicines being exported included Prozac, Xenical, Propecia and Viagra.
Brentnall and Vanilla Limited each pleaded guilty to 15 charges and Young to five charges of selling a prescription medicine by retail without a prescription. The defendants all pleaded guilty to four charges of possessing a prescription medicine without reasonable excuse.
Pleas of guilty were also entered by Vanilla Limited to five charges under the Crimes Act of making a false document with intent to deceive and one charge of attempting to export a controlled drug contrary to the Misuse of Drugs Act 1975.
Vanilla Ltd was fined $22,650 and ordered to forfeit seized medicines with an estimated value of more than $100,000. Brentnall was fined $6650 and Young was fined $4050. A total of $6890 in court costs was imposed against the three defendants. In addition the Ministry was awarded costs of $25,000.
The defendants were all convicted and sentenced on February 3 this year, but details of the case were suppressed after the defendants signalled they would appeal for continuation of name suppression. This appeal was subsequently dropped.
The Ministry's Team Leader of Medicines Control, Rachel Read today described the case as a carefully-planned attempt to flout New Zealand and international laws on medicines control, with little regard for the safety of consumers.
In May and in June 2002 Ministry of Health investigators seized medicines for export with an estimated wholesale value of more than $100,000. Counterfeit packaging had been used to disguise prescription medicines as dietary supplements and throat lozenges.
A search warrant was executed at a private Dunedin address in June 2002 during the investigation. At the address investigators located 19 cartons of prescription medicines, sales records and receipts, customs labels indicating Fiji as the country of origin, and postage and packaging materials. The Ministry believes the operation may have been turning over as much as $300,000 a month.
This is the Ministry's third prosecution of an internet-based operation which has involved breaches of the Medicines Act 1981 in relation to the sale of prescription medicines.
"This prosecution should serve as a warning that the Ministry takes breaches of the Medicines Act very seriously,'' Ms Read said. "The Ministry will continue to actively investigate people or companies attempting to flout the law in this manner."
"It's also a timely reminder to people that they should not be buying prescription medicines from any source, including the internet, without a prescription. Not only is it illegal, but there are also very real health risks involved. Prescription medicines are classified as requiring a prescription from a doctor or authorised prescriber, because of the risk to health they present if they are not clinically appropriate for the individual or are not taken properly. Furthermore, if a medicine is not obtained through a lawful chain of distribution, there can be no assurances that the medicine is what it says it is, or that its quality and safety have not been compromised."
Convictions of this nature against pharmacists will be reported by the Ministry to the Pharmacy Council, which is able to take disciplinary action.
11 February 2005
New Zealand's safety review of COX-2 agents to be released next week
The Ministry's medicine regulatory arm, Medsafe, is expected to complete and release its review of the safety of COX-2 inhibitor pain-killers as early as next week.
Medsafe Principal Advisor Stewart Jessamine welcomes the Australian Therapeutic Goods Administration (TGA) review, which is the first of the major regulatory authorities to release their conclusions on the safety of this group of medicines. The TGA's media statement is available on the TGA web site.
Medsafe has worked closely with the Australian TGA, and their recommendations will be taken into consideration when a New Zealand decision is made.
The release of Medsafe's conclusions on the safety of COX-2 inhibitor pain-killers is likely to coincide with statements from the US and European regulatory agencies on the same subject.
The reviews by all four different regulatory agencies follow the worldwide recall of the COX-2 inhibitor, Vioxx in October last year.
Dr Jessamine says in the interim, the Ministry advises that anyone taking a COX-2 inhibitor should follow the advice provided by the Ministry's expert committee, released in December last year, that COX-2 agents are not recommended:
- for routine use in patients with rheumatoid arthritis or osteoarthritis except where the patient is at "high risk" of developing a serious gastrointestinal adverse effect from other standard non-steroidal anti-inflammatory agents
- for patients at high risk of heart attack or stroke
- for patients already taking aspirin
- for routine relief of post-operative pain.
Patients already taking COX-2 agents on a regular basis should discuss the continuing use of these medicines with their GP or specialist. Prescribers should discuss with their patients the available alternatives to the COX-2 agents, and review the risks and benefits of these alternatives compared with the emerging clinical concerns about the COX-2 agents, before deciding on the best course of treatment for that individual. If the patient and prescriber decide that continued use of a COX-2 agent is appropriate, use of the lowest effective dose is prudent.
A number of alternative anti-inflammatory agents for the treatment of osteoarthritis and rheumatoid arthritis are available in New Zealand. Unlike the COX-2 agents, many of these agents are funded by PHARMAC.
Dr Jessamine says New Zealand makes its own decisions on medicine regulation separately from Australia. The prescribing, funding and marketing situation of the agents is slightly different in each country. For example, in Australia, Mobic and Celebrex are funded, and Prexige, Arcoxia and Bextra are not currently available. In New Zealand all of the agents other than Prexige are actively marketed but none are funded.
For more information contact:
Peter Abernethy
Communications Manager
ph: 04-496-2008
or 021-366-111
www.health.govt.nz/news-media
COX-2 agents available in NZ include:
| Ingredient | Brand name |
|---|---|
| celecoxib | Celebrex |
| valdecoxib | Bextra |
| meloxicam | Mobic |
| etoricoxib | Arcoxia |
| parecoxib | Dynastat |
Alternatives to COX 2 inhibitors - standard anti-inflammatory agents:
| Ingredient | Brand names |
|---|---|
| diclofenac | Apo-Diclofenac Apo-Diclo SR Voltaren |
| ibuprofen | I-Profen Brufen Brufen Retard |
| sulindac | Clinoril Daclin |
| tiaprofenic acid | Surgam Surgam SA |
| ketoprofen | Orudis Oruvail |
| naproxen | Naxen Naprosyn SR Synflex |
| tenoxicam | Tilcotil |
| piroxicam | Piram D |
10 February 2005
Australia, New Zealand announce start-up date for Joint Therapeutic Products Agency
The New Zealand and Australian Governments have announced a firm operational date for the new Trans Tasman Therapeutic Products Agency of no later than 1 July next year, though it could start earlier.
Health Minister Annette King and Australian Parliamentary Secretary for Health, Christopher Pyne say it is vital to ensure the new regulatory scheme is world class and to recognise the importance of consulting with industry, consumers and other interested parties. "This is a ground breaking move and that is why it is so important to get it right," says Ms King.
The joint regulatory agency will replace Australia's Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).
The election cycle in both countries has made it difficult to adhere to the original timetable of establishing the agency in July of this year, Ms King says.
Both Ministers also recognised that industry "needs certainty around the introduction of the new scheme and needs time to review and comment on the rules of the regulatory agency, and to put in place transitional arrangements," she says.
The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. This includes prescription and over the counter medicines, complementary medicines, medical devices and blood.
The new agency will be accountable to both the New Zealand and Australian Governments. It will be recognised in law in both countries and will assume responsibility for the regulatory functions undertaken by the TGA and Medsafe.
Ms King said the new agency offered a number of benefits for both countries by creating a single market for drugs and therapeutic products regulation which should ensure that consumers have early access to new products entering the market, while maintaining confidence in public health and safety.
"Over the past three weeks, including today, I have had meetings with representatives of all sectors affected by the establishment of the new agency, starting with pharmaceutical, medical devices and over-the-counter medicines. My last meeting was this morning, with complementary health products representatives, who speak on behalf of more than 75 per cent of the New Zealand market in dollar terms.
"I am very pleased at the commitment they have all given in principle to the establishment of a joint regulator. Between now and the start-up a joint working party of all sectors will work through the remaining details of how the scheme will operate."
More information about the proposed Trans Tasman regulatory agency can be found on www.anztpa.org
Contact: John Harvey 021 461 675 or John Saunders 021 880 050.
2 February 2005
Medsafe Advice on Co-proxamol
Medsafe is aware the UK-based Medicines and Healthcare products Regulatory Agency (MHRA) has decided to withdraw the painkiller Co-proxamol from the market over the next 6-12 months.
Co-proxamol is not available in New Zealand. However, two similar products Capadex and Paradex which contain the same ingredients (paracetamol and dextropropoxyphene) are available.
Medsafe will be asking the MHRA for a copy of the risk-benefit review carried out on Co-proxamol, which it will consider against data on the safety and use of Capadex and Paradex in New Zealand. The New Zealand review will also take into consideration the availability of alternative medication, before deciding on the most appropriate action for this country.
Given the toxicity in overdose of these products, especially when taken with alcohol, Medsafe is advising prescribers to check the suitability of these products for their patients. The data sheets for both Capadex and Paradex already contain warnings about the potential toxicity of these medicines when used in particular patients or concurrently with alcohol.
The NZ Poisons Centre has advised Medsafe that in 2001-02 there were seven deaths in New Zealand where dextropropoxyphene was the primary cause, and a further 13 where it was part of an overdose cocktail. The approximate rate of death by overdose is 1-2 per 100,000 prescriptions. Analgesics are frequently taken in suicide attempts along with a number of other medicines.
Link to UK MHRA web site: http://www.mhra.gov.uk/
