Revised: 14 May 2013
Publications
Media Releases for 2007
19 October 2007
Medsafe warns of "natural health" hazards
The Ministry of Health's medicines and medical devices regulator Medsafe is warning New Zealanders to be aware of what they're buying when shopping for herbal remedies, following charges brought against a Chinese herbalist in Auckland.
In the Auckland District Court, 46-year-old George Zheng and his Company, Ichi Trade (NZ) Ltd have been fined a total of $42,500 plus costs after both pleaded guilty in February to various charges brought under the Medicines Act 1981. Mr Zheng pleaded guilty to one charge each of advertising a ‘new’ medicine and sale of a prescription medicine other than by a pharmacist in a pharmacy and his Company pleaded guilty to one charge of advertising and five charges of selling a 'new' medicine.
On sentencing Zheng and Ichi Trade (NZ) Ltd, Judge Aitken commented that "…in the absence of any assessment by health professionals as to the suitability of the person seeking to purchase the tablets, coupled with a complete lack of any proper assessment of the quality, safety and efficacy of these pills, together with the known risk of both Sildenafil and Sibutramine, leave me in no doubt that there was a significant risk of real harm to consumers from the defendants' offending".
The charges were laid after Ministry officials as part of a surveillance operation noticed a sign in the window of Mr Zheng's Panmure Chinese herbal clinic advertising "Natural Viagra", in June 2006. A purchase of the ‘Natural Viagra’ was made and a search of the premises was subsequently carried out. Several 'new' medicines were found, including products containing the prescription medicines sildenafil and sibutramine. Viagra is the only product containing sildenafil that is approved for distribution in New Zealand and Reductil is the only approved product containing sibutramine. A ‘new’ medicine is a medicine that has not been approved for distribution in New Zealand.
"In the absence of adequate regulation, this case demonstrates that consumers simply can't be assured about the safety or quality of the "natural" health product they are purchasing," said Derek Fitzgerald, Medsafe Team Leader, Compliance.
He says the defendant was claiming to sell a "natural" medicine which includes a perception that the product is safe, when in fact he was selling a prescription medicine which had the potential to cause serious harm.
"It's vital we send signals to the community of retailers selling natural medicines that they risk prosecution if they sell products containing pharmaceuticals and the onus is on them to make sure the products they sell comply with the law."
"Medsafe has increased its surveillance at the border to decrease the importation of unapproved medicines, and will take steps to prosecute companies and individuals selling products that contain pharmaceuticals unless these products have Ministerial consent to market", says Derek Fitzgerald.
Background and drug information:
During its investigation Medsafe seized several products from the premises of Ichi Trade, and found that they contained prescription medicines. Three contained the substance sildenafil - the active ingredient present in Viagra to treat erectile dysfunction, and one other contained sibutramine, the active ingredient in Reductil, a medicine used to treat obesity.
Sildenafil has known serious risks which affect the circulatory system. Its use is contra-indicated in patients with certain cardiac conditions. Information available on the Medsafe website indicates that patients should not take Viagra in certain circumstances, including the following situations: (a) when being treated with a certain group of medicines (nitrates) for angina or other heart conditions; (b) when sexual intercourse would be inadvisable due to heart or blood vessel problems; (c) following a stroke or heart attack in the previous six months; and (d) when suffering from severe liver problems and (e) when blood pressure is unusually high or low and not effectively treated.
Sibutramine can cause increased blood pressure and heart rate and cannot safely be taken by a range of people, including those with glaucoma, mental illness and severe liver or kidney problems. It should not be used in combination with other medicines such as some antidepressants and migraine treatments.
Medsafe is particularly concerned about the safety of one of the products (labelled “Kang Da”), as it was found to contain nearly twice the maximum approved dose of sildenafil in a single capsule. Following receipt of the test results in July 2006, the Director-General of Health issued a statement pursuant to Section 98 of the Medicines Act 1981. The statement warned the public of the safety risks of using the medicines mentioned above and stated that sildenafil is known to interfere with some heart medications and its use could be fatal to some individuals.
ENDS
For further information, please contact:
Michael Flyger
Media Advisor
Ph: 04 496 2265
27 September 2007
Medsafe requests Ritalin SR be made available
Following Medsafe concerns about the safety profile of the medicine Rubifen SR, Pharmac has announced it will make Ritalin SR available to people who experience serious side-effects following use of Rubifen SR, the subsidised brand of slow-release methylphenidate.
Medsafe requested Ritalin SR be made available after a number of reports to the Centre for Adverse Reactions Monitoring (CARM) of serious reactions in patients following the change from Ritalin SR to Rubifen SR. About 6000 patients are prescribed methylphenidate in New Zealand.
Medsafe Interim Manager Dr Stewart Jessamine said between February and 21 September this year CARM received 88 reports of adverse reactions. More than half of these reports were of reduced therapeutic effect. This finding was not unexpected as it is well known that for some patients the way they respond to a medicine changes when the brand of the medicine supplied changes, even though the active ingredient, in this case methylphenidate, remains the same.
However, in this case, a number of patients, in particular children aged under 17, developed unusual and severe side effects, including mood disorders and irritability, following the change to Rubifen SR.
"Due to the number and severity of the adverse reactions reported to Rubifen SR, and the absence of any reports of a similar nature for Ritalin SR, Medsafe's Medicines Adverse Reactions Committee has asked Pharmac to make Ritalin available to those patients who experience serious side-effects, Dr Jessamine said."
Since the first reports of aggression as a side effect of Rubifen SR were made to the CARM Medsafe has been collecting data and investigating Rubifen SR to determine what might cause these side effects.
Dr Jessamine said:”To date there is no evidence to suggest that these side effects are due to a manufacturing problem or an issue with Rubifen SR delivering the wrong dose of methylphenidate or delivering it too quickly“.
Anyone who was taking Rubifen SR and who developed behavioural, psychiatric or other serious side-effects should contact their GP to talk about the best ADHD treatment option for them.
Prescribers are asked to report all side effects to methylphenidate to the Centre for Adverse Reaction Monitoring at the New Zealand Pharmacovigilance Centre, PO Box 913, Dunedin.
Background
The Centre for Adverse Reactions Monitoring has provided details of the reports of side effects in 56 children to Medsafe. The data reports that 75% reported loss of effect (42 children), 55% reported unusual psychiatric events (31 children), including mood disorders, irritability, reported hallucinations (1 case) and suicidal ideation (2 cases), and 55% reported aggressive and oppositional defiant types of behaviour (20 children). A number of children reported more than 1 of the above adverse effects. All of these side effects occurred a few hours to days after patients switched over to Rubifen SR.
A literature review of the safety of methylphenidate confirms that these types of psychiatric and severe behavioural side effects have been reported in children, and less commonly in adults. All brands of methylphenidate can cause these side effects and their occurrence and severity are not related to the dose of medication being taken. As in the New Zealand reports, most patients who develop these side effects do not exhibit this type of behaviour before being started on methylphenidate.
Medsafe has also reviewed the global adverse reactions data for methylphenidate including a report listing side effects for Rubifen SR from Argentina, the only other country that markets this product. The global data confirms that serious adverse reactions to methylphenidate occur however the data from Argentina does not include any reports of aggressive behaviour or mood disorders.
Medsafe has extensively reviewed the manufacturing process, formula and testing performed on Rubifen SR before it came onto the market to determine if the side effects may be due to the quality of Rubifen SR.
Medsafe is continuing to investigate this product and is conducting its own testing of Rubifen SR. It has also asked AFT Pharmaceuticals, the manufacturer of Rubifen SR to urgently provide more data about the quality and safety of this medicine.
It will take Medsafe several weeks to complete its investigations to allow it to determine what is the likely underlying cause of the increased rate of reporting of serious side-effects.
Ends
21 August 2007
Prexige 200mg and 400mg tablets to be withdrawn in New Zealand
Consents allowing the supply of 200mg and 400mg tablets of the COX-2 anti-inflammatory medicine Prexige have been revoked in New Zealand by the Medicines and Medical Devices Safety Authority, Medsafe.
Novartis, the pharmaceutical company sponsoring the medicine, is issuing a recall notice to suppliers of the tablets today.
The decision has been reached by Medsafe after it reviewed local and international safety data for Prexige relating to reports of severe liver damage in patients using this medication at doses of 200mg and above. In making the decision, Medsafe discussed the overall risks and benefits of the use of Prexige with medicines regulators in Australia, Singapore and the United Kingdom.
Medsafe's interim manager, Dr Stewart Jessamine, says Medsafe and the Medicines Adverse Reactions Committee (MARC) concluded that the data for higher doses of lumiracoxib, the active ingredient in Prexige, support an association with liver damage that was greater than that seen for other anti-inflammatory medicines.
"This increased risk of liver damage for Prexige outweighs any of the potential benefits claimed for the 200mg and 400mg dose," Dr Jessamine says.
"We, therefore, have revoked the consent of these doses. However, as there are no products containing 200mg of lumiracoxib marketed in New Zealand only the Prexige 400mg product will be recalled. We believe the recall will affect around 1000 patients who take Prexige 400mg tablets in New Zealand. Anyone who has general concerns should contact their doctor for advice in the first instance."
Medsafe also reviewed the safety of Prexige 100mg the product indicated for use in osteoarthritis.
"The data available from clinical trials and reported side effects in the United Kingdom, Europe, Canada or South America indicate that severe liver damage with Prexige 100mg/day is rare. The frequency with which liver damage is reported for Prexige 100mg does not appear to be significantly different from that seen for other anti-inflammatory medicines," Dr Jessamine says.
Medsafe has accepted the interim advice of the Medicines Adverse Reactions Committee (MARC) that Prexige 100mg should remain on the market and its safety be closely monitored.
To bring this into effect Medsafe has: decreased the maximum daily dose of Prexige to 100mg; limited the approved indication to the treatment of osteoarthritis; and added warning statements to the prescriber and patient information sheets for Prexige advising that patients should have blood tests to assess their liver function before starting treatment and every month thereafter.
"When taking a medicine you must take into consideration both the possible benefits and the potential risks as all medicines can cause severe side effects. Patients taking Prexige 100mg tablets for osteoarthritis should contact their doctor about having blood tests to check and monitor their liver function. I also encourage GPs to report any abnormalities found in these tests to the Centre for Adverse Reactions Monitoring at the University of Otago. Patients taking Prexige for acute pain should contact their general practitioner to discuss other analgesics that may be suitable," Dr Jessamine says.
Medsafe and the Medicines Adverse Reactions Committee (MARC) will continue to closely monitor the safety of Prexige 100mg tablets, and will review its ongoing availability in light of any new data that emerges.
In addition to the recall of Prexige 400mg, Novartis will provide written advice on the safety issues associated with Prexige to pharmacists and doctors. This advice will include the need to conduct monthly monitoring of patients’ liver function and to report any abnormalities to the Centre for Adverse Reactions Monitoring in Dunedin.
ENDS
Lucy Taylor Media Advisor, Ministry of Health
04 496 2349 / 027 687 5642
Questions and Answers
What is Prexige?
Prexige is a prescription medicine. It is not funded by PHARMAC. Prexige has consent in New Zealand as 100mg, 200mg and 400mg tablets. The Prexige range of products is approved for use in both Australia and New Zealand for the short-term treatment of acute pain at doses up to 400mg/day; and for the management of osteoarthritis at doses of 100mg/day.
Lumiracoxib, the active ingredient of Prexige, is a COX-2 inhibitor, and belongs to the same class of anti-inflammatory medicines as Vioxx, which was withdrawn worldwide in 2004 due to concerns about its cardiac safety.
What is the issue with Prexige?
The Therapeutic Goods Administration (TGA) of Australia revoked the registration of Prexige due to an increasing rate of reports of severe liver damage in patients taking this medication at doses of 200mg and above. The 8 cases reported in Australia associated with use of Prexige included 2 cases of death from liver failure and 2 patients requiring liver transplants.
Have any adverse reactions been reported in New Zealand?
The Centre for Adverse Reactions in Dunedin has received a total of 15 case reports of adverse reactions to lumiracoxib in the 2 years since it was approved. There are no reports of liver damage (hepatic injury) with this product in New Zealand.
How has the decision to withdraw consent for 200mg and 400mg doses been reached?
All anti-inflammatory medicines are known to cause liver damage and in rare cases use of these medicines can lead to severe side effects such as liver failure. Medsafe and the Medicines Adverse Reactions Committee (MARC) has evaluated safety data from the World Health Organisation (WHO); the Australian Therapeutic Goods Administration (TGA); and the pharmaceutical company Novartis to assess the possible association between use of Prexige and severe liver damage. Medsafe and the MARC concluded that there is evidence of a signal that lumiracoxib carries a risk of severe liver damage but that the strength of the association is unable to be defined on the basis of the currently available evidence. The data supports a clear association with higher doses of lumiracoxib, being 200mg and 400mg, but that for 100mg there is no evidence to suggest the risk of liver damage is higher than that found for other anti-inflammatory medicines. Following completion of its evaluation, Medsafe discussed its findings with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, the TGA and the medicines regulator in Singapore, before coming to a decision.
How are the consents withdrawn on the basis of the data evaluation?
Medsafe and the Medicines Adverse Reactions Committee (MARC) recommended that the consent for Prexige 200mg and 400mg tablets be revoked in New Zealand, under Section 35(1)(a) of the Medicines Act 1981, on the grounds that Prexige 200mg and 400mg tablets can no longer be regarded as medicines that can be administered or used safely for the purposes indicated in the application for consent. The Ministerial power to revoke consent under Section 35(1)(a) of the Medicines Act 1981 has been delegated to the Director-General of Health. Revoking consent of the 400mg tablets will necessitate a recall of stock distributed to pharmacy and wholesaler level.
Why are the 100mg tablets of Prexige still available?
The Medicines Adverse Reactions Committee (MARC) recognised that there is a clinical niche for this lower strength of Prexige for patients with osteoarthritis who have not found other treatments to be effective. Additionally, it is not yet clear whether the 100mg tablets carry the same risk of severe liver damage as the higher strength tablets. Medsafe and the MARC recommend that, at present, Prexige 100mg tablets should remain available in New Zealand for the treatment of osteoarthritis. However, to maximise the safe use of this medicine, Medsafe and the MARC recommended that the indications for Prexige be limited to management of osteoarthritis, and that new warning statements be added to the prescribing and consumer information sheets. In addition, it was recommended that Novartis issue a letter to all doctors in New Zealand, to advise them of the need to conduct monthly monitoring of patients’ liver function and to report abnormalities to the Centre for Adverse Reactions Monitoring in Dunedin.
How many patients are affected?
Data supplied by Novartis indicates that in the past 3 months 500-600 people per month have purchased 100mg/day packs of Prexige, and 1000-1100 patients per month have purchased packs of Prexige containing 10 tablets of 400mg strength.
What should patients on this medicine do?
Patients who are worried should contact their GP for advice. Patients taking Prexige for osteoarthritis should contact their GP about having a blood test to assess their liver function. Patients taking Prexige for acute pain should contact their general practitioner to discuss other analgesics that may be suitable.
How are patients and doctors being advised?
The medicine sponsor, Novartis, is issuing a recall for the 400mg Prexige tablets today and this includes writing to doctors and pharmacists.
What is happening in other countries?
Prexige remains on the market in the United Kingdom, Europe and Canada. Medicine regulatory authorities in these counties are also in the process of reviewing the safety data.
13 August 2007
The Therapeutics Products and Medicines Bill has been postponed
The Government is not proceeding at this stage with legislation that would have enabled the establishment of a joint agency with Australia to regulate therapeutic products.
The Therapeutics Products and Medicines Bill has been postponed, but will remain on the Order Paper to be revisited when sufficient parliamentary support is available.
For information and/or assistance with regulatory matters related to therapeutic products please contact Medsafe.
