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Revised: 14 May 2013

Media Releases for 2001

17 Dec 2001 Director General of Health Privileged Statement Under Section 98 of the Medicines Act 1981 - Cheng Kum/Shen Loon
20 Nov 2001 Ministry of Health consulted on Estelle-35 ED recall
3 Oct 2001 European Medicines Agency advice matches that given in New Zealand
26 Sep 2001 Changes to the way Zyban is prescribed
17 Aug 2001 Zirconia Ceramic Femoral Head Protheses Recalled
15 Mar 2001 New Zealand and Australia to consider joint medicines regulatory body
1 Feb 2001 Ministry Issues Warning about Adrenaline Kit

17 December 2001

Director General of Health Privileged Statement Under Section 98 of the Medicines Act 1981 - Cheng Kum/Shen Loon

DIRECTOR General of Health Dr Karen Poutasi today warned the public to avoid consuming Cheng Kum or Shen Loon dietary supplement capsules after tests revealed they contain a prescription medicine known as betamethasone.

"Anyone currently taking Cheng Kum or Shen Loon should contact their medical practitioner for advice. It is also essential for any person who has taken these products in the last 18 months AND is about to have surgery, to advise their surgeon and anaesthetist. This is important as there is a risk of complications during surgery such as a sudden drop in blood pressure for anyone who has recently taken steroids."

"Betamethasone is a potent steroid (corticosteroid) which is used only under medical supervision, for the treatment of conditions such as rheumatoid arthritis".

The prolonged use of oral steroids is associated with side effects, including increased susceptibility to infection, skin damage, acne, osteoporosis, diabetes, fluid retention and weight gain.

Dr Poutasi said two medical practitioners reported to Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) in October and November this year that patients using Cheng Kum or Shen Loon had experienced side effects associated with prolonged oral steroid use. Other practitioners contacted Medsafe seeking clarification on whether the products contained steroids.

Subsequent tests by the Institute of Environmental Science and Research (ESR) and the Australian Therapeutic Goods Administration confirmed that the products contain the steroid betamethasone.

"We have advised doctors about the dangers of Cheng Kum and Shen Loon, and provided them with information on how to wean patients off these products as there is a risk associated with sudden cessation of prolonged use of steroids in some patients."

The Ministry of Health has also sent letters to approximately 200 patients known to be importing the products, and has advised them to cease importation and seek medical advice. However, there may be substantially more people using these products, Dr Poutasi warned.

Cheng Kum has previously been advertised for use in the treatment of various conditions including the promotion of joint mobility, healthy skin, menopausal symptoms and painful menstruation. It was also promoted as being beneficial while consuming alcoholic drinks.

The packaging of both products indicate the capsules contain herbal and animal extracts, and makes no mention of the steroid betamethasone.

As both Cheng Kum and Shen Loon contain the prescription medicine betamethasone these products are considered to be medicines distributed without the consent of the Minister in contravention of the Medicines Act 1981.

ENDS

Background

This is the second time the Director General of Health has issued a privileged statement about Cheng Kum.

In December 2000, Dr Poutasi advised consumers to stop taking Cheng Kum because it contained a pharmacy only medicine chlorpheniramine (an antihistamine), which can cause drowsiness.

At that time the Ministry of Health worked with the New Zealand distributor of Cheng Kum, Lee Bye (NZ) Ltd, to recall this product.

Recent testing has confirmed that Cheng Kum contains the prescription medicine betamethasone, in addition to chlorpheniramine. Testing also revealed that Shen Loon contains betamethasone.

It is not illegal to import a product which contains a pharmacy only medicine for personal use, and the Ministry of Health was aware a number of patients continued to import both Cheng Kum and the similar product Shen Loon.

However, it is illegal to import a prescription medicine for personal use. Therefore, Medsafe has instructed Customs to seize all imports labelled as Cheng Kum or Shen Loon. These products originate from Malaysia, and the Ministry of Health is in contact with the Malaysian health authorities.

What is the usual dose range for oral betamethasone?

The usual dose range for oral betamethasone is between 0.5 and 5mg per day. Testing at ESR and the Australian Therapeutic Goods Administration confirmed that Cheng Kum and Shen Loon contain between 0.1 and 0.3 mg of the steroid betamethasone per capsule.

What are the risks associated with weaning a patient off steroids too quickly?

As the use of steroids can suppress the body's normal production of its own adrenal steroid hormones, some patients may need to be slowly weaned off these products under the supervision of their doctor. If weaned too quickly, patients may have a lowered resistance to infection or may present with low blood pressure.

Some patients undergoing surgery may need to have their steroids reintroduced during and after a surgical operation to prevent complications.

A photo of Cheng Kum and Shen Loon is available on the Medsafe website www.medsafe.govt.nz/hot/alerts/ChengKumandShenLoon/chengKumpictures.asp

For further information contact:
Hayley Brock
Media Advisor
(04) 496 2115, 025 495 989
www.moh.govt.nz/news-media


20 November 2001

Ministry of Health consulted on Estelle-35 ED recall

Women using the oral contraceptive Estelle-35 ED should make an appointment with their GP or Family Planning Clinic this week after the pill was recalled by its manufacturer Douglas Pharmaceuticals Ltd.

Medsafe Senior Advisor Dr Stewart Jessamine said Douglas Pharmaceuticals Ltd recalled the oral contraceptive in consultation with the Ministry of Health after a mistake occurred with the pill's packaging.

"Douglas Pharmaceuticals has reported there was one incident of a single white inactive tablet being present in place of a yellow active tablet in the blister strip."

"The company informed the Ministry of Health on Friday 16 November as soon as it became aware of the problem and has kept the Ministry informed of its plans and processes for the recall."

Estelle-35 ED is packed in a similar way to many oral contraceptives. There are 21 yellow active tablets and seven white inactive tablets on each blister strip. The tablets have to be taken in the prescribed sequence.

Dr Jessamine said there was a small chance women taking Estelle-35 ED may become pregnant as a result of the packaging problem.
"There is a chance that an inactive pill taken within the first or last seven days of the active pill cycle will reduce the contraceptive effectiveness of the product."

"Women are advised to continue taking the product but to take additional barrier contraceptive measures for the next seven days or until they see a medical practitioner. During the consultation it may be appropriate that a test to be performed in order to rule out pregnancy."

Dr Jessamine said Douglas Pharmaceuticals Ltd has made arrangements to reimburse patients for the consultation fees and new prescription costs.

ENDS

For more information contact:
Hayley Brock
Media Advisor
(04) 496 2115, 025 495 989
http://www.moh.govt.nz


3 October 2001

European Medicines Agency advice matches that given in New Zealand

Information from the European medicines regulatory body regarding the use of combined oral contraceptives is in line with advice the Ministry of Health has given to New Zealand women since 1996.

The European Agency for the Evaluation of Medicinal Products (EMEA) has published its assessment on combined oral contraceptives and venous thromboembolism (VTE) or blood clots.

It advises there is a very small risk of VTE with all combined oral contraceptives and that the risk of developing a clot is higher in the first year. The EMEA has also confirmed that the risk of VTE with third generation pills is approximately twice that of second generation pills.

Medsafe Advisor Dr Natasha Rafter said Medsafe was pleased the European Agency had acknowledged the difference in risks between second and third generation pills and advised doctors to take the risks into account when prescribing and counselling about contraceptive choice.

"This advice broadly mirrors the advice issued five years ago in New Zealand to patients and doctors that third generation pills carry a small increased risk of VTE over other oral contraceptive pills. Women should discuss the risks and benefits of contraceptive treatments with their doctor, and doctors should consider a low dose second generation pill when starting treatment."

"The use of third generation pills in New Zealand has significantly decreased since advice was first issued and it is now common practice in this country for doctors to advise women about the benefits and risks of taking oral contraceptive pills and to assess each woman carefully for risk factors."

"Medsafe continues to make information available on the safety of oral contraceptives through its website and consumer information leaflets. Doctors and health clinics need to remain vigilant when prescribing oral contraceptives and provide women with all the information available."

Dr Rafter said that for every 10,000 women on a second generation oral contraceptive for a year, 2 women would be expected to develop a clot. The figure for third generation oral contraceptives is approximately 3 to 4 per 10,000 women per year.

The EMEA have confirmed that the risk of developing a VTE with a third generation oral contraceptive pill is approximately twice the risk of VTE posed by second generation pills and that the difference in risk cannot be explained by either bias or confounding factors.

"In absolute terms while the risk of developing a blood clot when taking any oral contraceptive is very low, if women have any concerns about their choice of contraceptive we would advise them to talk to their family practitioner or family planning clinic," Dr Rafter said.

Background Information

Combined oral contraceptives contain both an oestrogen and a progestogen. Third generation combined oral contraceptives contain progestogens called desogestrel or gestodene and include the pills known as Marvelon, Mercilon, Femodene and Minulet.

Second generation combined oral contraceptives contain progestogens called levonorgestrel or norethisterone. Examples of second generation pills include Microgynon, Monofeme, Brevinor and Norimin.

Blood clots are associated with both second and third generation oral contraceptives however research shows third generation pills are approximately twice as likely to cause blood clots as second generation pills.

The most serious complication of a clot is a pulmonary embolism when the clot has travelled to the lungs.

Consumer information including symptoms of a clot can be found on the Medsafe website at www.medsafe.govt.nz/Consumers/medicine/oralcontraceptives.htm
Information for doctors can be found at www.medsafe.govt.nz/Profs/PUarticles/OCletter.htm
The EMEA's assessment can be found at www.emea.eu.int/htms/human/press/pos.htm

For more information contact:
Hayley Brock
Media Advisor
(04) 496 2115, 025 495 989
http://www.moh.govt.nz


26 September 2001

Changes to the way Zyban is prescribed

Smoking cessation drug Zyban should be prescribed only after a person has unsuccessfully trialed other anti smoking treatments, an advisory committee to the Health Minister announced today.

The Medicines Adverse Reactions Committee (MARC) is making this recommendation following a review of adverse reactions to bupropion, otherwise known by its trade name Zyban.

Senior Medical Advisor Dr Stewart Jessamine, who sits on the committee, said Zyban's safety had been closely monitored since it entered the New Zealand market in the middle of 2000.

"MARC is advising prescribers that Zyban should be considered only as a secondary intervention and as part of a smoking cessation programme."

"We are advising doctors to prescribe Zyban only after the person who wants to quit smoking has unsuccessfully trialed other smoking cessation treatment, including nicotine replacement therapy."

New Zealand's Centre for Adverse Reactions has recorded 218 reports of adverse reactions to Zyban up until August this year.

Dr Jessamine said the reports were collected from doctors, pharmacists or pharmaceutical companies and represent "suspicions" Zyban could have been involved in the adverse reaction.

"In many cases it is difficult to establish the contribution of Zyban. Many of the adverse events reported may have been symptoms of nicotine withdrawal making assessment of the reactions difficult."

Allergic or hypersensitivity reactions such as a rash and itch, psychological reactions such as insomnia, depression and anxiety, and nervous system reactions such as a tremor and headache were the most commonly reported. Although not always serious, the reactions were severe enough for nearly all of the patients to stop treatment.

Dr Jessamine said the nature and number of reactions to Zyban in New Zealand followed a similar pattern to reports in Australia and the Untied Kingdom.

"Despite reports of adverse reactions, we are satisfied the benefits of bupropion still out-weigh the risks when the medicine is used appropriately. Our evidence would suggest that prescribers in New Zealand are using this product in a very responsible manner."

"Smoking is the single greatest cause of premature death in New Zealand and the evidence currently available in New Zealand and overseas indicates that the benefits of stopping smoking continue to outweigh the risk of adverse events associated with use of Zyban.

"Patients already on Zyban should continue taking the tablets and if they have any concerns about side effects they should contact their doctor. "

The MARC will continue to review New Zealand adverse reaction reports to Zyban and the related international literature in the interests of public safety.

Zyban information for patients is on www.medsafe.govt.nz/Consumers/cmi/z/Zyban.pdf

For more information contact:
Hayley Brock
Media Advisor
(04) 496 2115, 025 495 989
http://www.moh.govt.nz

Background Information

What is Zyban?

Zyban or bupropion is an antidepressant which was found to have anti-smoking actions. It is different from other smoking cessation therapies in that it does not contain nicotine.

It is a prescription medicine and is only available from a doctor and must only be used on carefully selected patients under medical supervision.

The side effects of Zyban are completely different from smoking cessation products containing nicotine. Side effects such as dry mouth, insomnia, skin rashes, mood swings and vivid dreams. On rare occasions, seizures have been reported with Zyban.

A data sheet which contains all the information about the medicine and its risk profile (side effects) is on the Medsafe website www.medsafe.govt.nz/Profs/Datasheet/z/zybantab.htm

Who shouldn't be prescribed Zyban?

It should be prescribed with extreme caution to :

If there are reports of adverse reactions, why isn't Zyban simply withdrawn from the market?

Despite reports of adverse reactions we are satisfied that the benefits of bupropion still out-weigh the risks when the medicine is used appropriately. Our evidence would suggest that prescribers in New Zealand are using this product in a very responsible manner.

Smoking is the single greatest cause of premature death in New Zealand and the evidence currently available in New Zealand and overseas indicates that the benefits of stopping smoking continue to outweigh the risk of adverse events associated with use of Zyban.

How well does Zyban work?

In clinical trials of people taking Zyban, 30-50% quit for four weeks. Only 20% of those taking placebo tablets were able to quit for four weeks.

What is the Medicines Adverse Reactions Committee (MARC)?

This committee is made up of general practitioners and specialists and advises the Minister of Health about adverse reactions to medicines. It meets four times a year and has examined the data on Zyban through the adverse reaction reports received from New Zealand's national medicine safety monitoring centre - the Centre for Adverse Reactions Monitoring (CARM)- and the experience of other international agencies.

New Zealand has the highest rate of reporting of adverse reactions to medicines per head of population. This reflects the degree of vigilance for these events by New Zealand health professionals and their commitment to reporting .

What has MARC advised?
What reactions are reported most frequently in New Zealand?

Reports are sent in by doctors, pharmacists and pharmaceutical companies and describe the reaction(s) that has ocurred which is suspected to be attributed to Zyban. The following is a list of the most frequently reported adverse reactions to Zyban received by the Centre for Adverse Reactions Monitoring.

Hypersensitivity/Skin
Urticaria
Rash
Pruritis

42
29
19
Psychiatric
Insomnia
Depression
Anxiety

35
28
23
Neurological
Tremor
Headache

22
21

Patients may also have been taking other medicines or have other medical conditions which may influence the likelihood of the medicine in question being the cause of the reaction.

The number of reports received for a medicine may be influenced by the extent of use of the product, publicity, and seriousness of the reactions. Also the total numbers of reactions may not represent the number of patients involved because a patient may have experienced more than one reaction.

Where can doctors and patients find out more information?

Doctors are encouraged to check Zyban's product information, otherwise known as a data sheet, prior to prescribing Zyban. This is available on the Medsafe website www.medsafe.govt.nz/Profs/Datasheet/z/zybantab.htm along with a Prescriber Update article describing the adverse reaction data collected so far and the MARC advice www.medsafe.govt.nz/Profs/PUarticles/zyban.htm

The article on Zyban will also be sent to doctors and pharmacists in the hard copy version of Prescriber Update in mid-October.

Patients already on Zyban should continue taking the tablets. If they have any concerns about side effects they should contact their doctor.

Zyban information for patients is on www.medsafe.govt.nz/Consumers/cmi/z/zyban.pdf


17 August 2001

Zirconia Ceramic Femoral Head Protheses Recalled

The Ministry of Health is working with suppliers and clinicians to identify New Zealand patients who may have received a brand of hip joint replacement which is currently the subject of a recall.

The zirconia ceramic femoral head prostheses, manufactured by Saint-Gobian Ceramiques Avancees Desmarguest in France is being recalled following reports of failure. The reports from France and the USA show that a small number of products manufactured since 1998 had an increased failure rate and disintegrated 13 –27 months' after implantation.

The French company is the major manufacturer of Zirconia implants in the world.

Ministry of Health senior medical advisor Dr Stewart Jessamine said that zirconia hip femoral head prostheses have been used in New Zealand for a number of years, and the Ministry has not had any reports of this problem or other device failure relating to this product in either Australia or New Zealand.

He said companies distributing the zirconia ceramic femoral heads in New Zealand have this week recalled all unused product and surgeons have not implanted them since notification late yesterday.

Approximately 5000 hip implant operations are performed in New Zealand each year.

"Of these approximately 300 patients per year receive the zirconia ceramic implant. This means that since 1998 approximately 1000 zirconia ceramic femoral heads have been implanted in New Zealand patients.

Dr Jessamine said patients who have had a zirconia ceramic femoral implant and experience a sudden development of a "grating sensation" in the hip, which may be audible, should see a GP and seek referral to an orthopaedic specialist. If patients are unsure whether they have this implant, they should contact the hospital or surgeon where the surgery was performed.

For more information contact:
Selina Gentry,
Media Advisor,
ph: 04-496-2483
or 025-277 5411
http://www.moh.govt.nz/news-media

Zirconia Femoral Heads Used in Hip Prostheses:
Hazard Alert and Recall
Questions and Answers:

Q: What types of hip are affected?

The device recall notice affects only hip implants containing a zirconia femoral component manufactured by the St Gobain Céramiques Advancées Desmarques company in France since 1998. It is important to note that hip implants with femoral head components made from other materials such as alumina ceramic or steel are NOT affected.

The Ministry of Health decided to recall hip implants containing zirconia components after it was notified of an increased rate of failure of the implants in 5 batches of the product manufactured since 1998. It is thought that a change to the manufacturing process of the St Gobain zirconia implants that occurred in 1998 may be implicated in the failure of the device and all hip implants manufactured since then should be considered to be suspect.

Hip prostheses are modular devices made up of several components, depending on the design. Whether or not a zirconia component has been used in a particular implant depends on the implanting surgeon's judgement as to the clinical situation of each patient. Under normal circumstances the rate of failure of hip implants is 1-in-10,000 units. The failure rate for some of the affected zirconia containing femoral head implants is approximately 6%.

Q: How many patients are affected in New Zealand?

It has been estimated that about 1000 New Zealand patients have been implanted with zirconia femoral heads prostheses since 1998. So far, no adverse event reports have been received by the Ministry of Health on the use of Zirconia ceramic femoral head hip implants in New Zealand.

Q: Which New Zealand companies are distributing these affected hip implants?

There are four companies supplying the New Zealand market with St Gobain Céramiques Advancées Desmarques zirconia femoral head components. Approximately 80% of the world market for zirconia femoral head prostheses is supplied by St Gobain Ceramiques.

Q: What are the timeframes for the hip failures?

The current spontaneous disintegration of the zirconia femoral heads appears to be occurring between 13 and 27 months after implantation. The Ministry is unable to determine if the failure rate for the affected devices will increase with prolonged use as long term studies are not yet available.

Q: Who has been notified?

The distributors of hip implants containing Saint Gobain zirconia femoral head components in New Zealand have sent information about the rate of failure of the device to the surgeons and the hospitals that have used this implant. All unused implants have been withdrawn from supply. The Ministry is exploring the possibility of contacting patients who have received a suspect Saint Gobain zirconia femoral head implant.

Q: How long will my hip replacement last?

It is not possible to make a definitive statement about each individual hip implant. The Ministry of Health in conjunction with regulatory authorities worldwide is trying to determine the extent of the problem. If you have received an implant from a batch which was not affected the implant should work for between 10-20 years.

Q: How many hips are affected?

If all St Gobain Céramiques Advancées Desmarquest zirconia femoral batches manufactured since 1998 are affected by the problem, approximately 200,000 hips will be affected worldwide and approximately 1000 hips in New Zealand.

Q: How do I find out what sort of hip I have?

If you have had an implant since the beginning of 1998 you could contact the surgeon who implanted the device, or the hospital where you had the hip implant operation. They should be able to check your medical records and advise.

Q: Are there any tests that will tell me if my hip is affected.

Currently there are no tests that will be able to detect whether the zirconia head is likely to fail in the future.

Q: How will I know if something has gone wrong with my hip? What should I do then?

If you experience a sudden development of a "grating sensation", which may be audible, you should seek orthopaedic advice.

Q: What are the potential clinical outcomes should my hip fail?

While failure of the device is not life threatening, you will need to have further surgery to replace the failed implant.

Q: What are the alternatives to Zirconia femoral heads?

There are other types of femoral heads made from steel and alumina (another type of ceramic).


15 March 2001

New Zealand and Australia to consider joint medicines regulatory body

Health Minister Annette King says the Government has instructed officials to begin investigating the possibility of a joint trans-Tasman medicines, medical devices and dietary supplements regulatory body.

The proposed agency would be responsible for approving products, setting standards and monitoring compliance, she said. It would replace the Australian regulator, the Therapeutic Goods Administration, and New Zealand's Medsafe, a unit of the Ministry of Health.

"Preliminary talks have begun with the Australian Government, but they are very much at a preliminary stage. Extensive consultation will be required, and, of course, there would also need to be new legislation in both Australia and New Zealand. A single set of regulations for Australia and New Zealand could potentially have many benefits for New Zealanders."

Mrs King said the investigation by officials would initially focus on the governance arrangements for the agency, which would be established by way of a treaty.

The Minister said that, in a related project, an Australian Taskforce reviewing administrative arrangements for health and safety regulations has developed proposals designed to improve efficiency across the therapeutic goods, food, gene technology and chemicals sectors. The taskforce has released a discussion paper, Working Together, which includes the proposal to establish a trans-Tasman Authority to be responsible for regulating therapeutic products for Australia and New Zealand.

Mrs King said the Taskforce paper also proposed that the Authority would perform contracted services, mainly for Australia, such as the assessment of chemical and gene technology products for other Australian regulators, and that the scheme might be further reviewed in five years with a view to incorporating trans-Tasman arrangements for setting food standards into the new Authority.

Mrs King said that the New Zealand Government participated in the Australian review on a 'without prejudice' basis, and it supported a stand-alone trans-Tasman therapeutic goods regulator.

"We have not yet considered whether we would accept the joint therapeutic goods regulator being part of a wider regulatory organisation as proposed in the Taskforce paper. Any changes to administrative arrangements for food standards would need further consideration and negotiation."

Mrs King said no commitment could be made on the regulation of gene technology in New Zealand till the report for the Royal Commission on Genetic Modification was considered.

Mrs King said New Zealanders who wished to comment on the Taskforce discussion paper could obtain a copy of the paper from the Medsafe website (www.medsafe.govt.nz), and could make submissions direct to the Australian taskforce.

For more information, contact John Harvey (04) 471 9305.


1 February 2001

Ministry Issues Warning about Adrenaline Kit

People who have an adrenaline kit, which is used for allergic reactions in children, are being urged to ensure the kit contains the appropriate needle for administering the drug.

The warning comes following advice to the Ministry of Health that an adrenaline kit, which does not contain a needle that is suitable for self administration, and is usually intended for use in hospitals only, has been purchased or prescribed to some individuals.

This alert only applies to the Adrenaline Min-i-jet Kit:

PHARMACY MEDICINE
Adrenaline 1:10,000
(as hydrochloride) 1mg per 10mL Injection (100 microgram/mL)
FOR INTRACARDIAL (IC) OR INTRAVENOUS USE
Min-i-jet pre-filled syringe
CSL

This product is produced specifically for hospital use and is not intended for use by individuals at home. The alert does not apply to the 1:1,000 strength which is supplied with an appropriate needle.

Team Leader Compliance, Peter Pratt said the Adrenaline Min-i-jet Kit 1:10,000 is used for emergency treatment of life-threatening allergic reactions. Without the needle, the medicine cannot be administered.

Anyone who has purchased or been prescribed this adrenaline kit should contact their doctor. There is an appropriate self administering device called EpiPen and EpiPen Junior which are available from pharmacies.

For more information contact:
Selina Gentry, Media Advisor, ph: 04-496-2483 or 025-277-5411
Internet address: http://www.moh.govt.nz/news-media

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