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Director-General's Privileged Statement

1 March 2005

Director-General's Privileged Statement Under Section 98 Of The Medicines Act 1981

Director-General of Health Dr Karen Poutasi is today warning people about three herbal products after investigation and testing revealed they contain undeclared prescription medicines.

These products are the Herbs Health brand of: Joint Plus capsules S.E.N Plus capsules Multistress capsules

The Ministry of Health's medicines safety authority (Medsafe) is ordering the recall of these three products because they illegally contain the prescription medicines frusemide, piroxicam or betamethasone.

These herbal products are not approved as medicines in New Zealand and pose a safety risk to consumers if taken without medical supervision.

The Herbs Health Joint Plus capsules and Herbs Health S.E.N Plus capsules both contain frusemide and piroxicam. Consumers are being warned to immediately stop taking these products.

Dr Poutasi says people using the Herbs Health brand of Joint Plus or S.E.N Plus should also seek medical advice from their doctor: if symptoms return or worsen if they feel unwell after stopping to discuss whether alternative treatment options are required if they have any concerns about their health

The Herbs Health Multistress capsules contain betamethasone, which is a potent steroid (corticosteroid) used to treat various inflammatory conditions, such as rheumatoid arthritis. Each Multistress capsule contains approximately 1.6mg of betamethasone.

Dr Poutasi urges anyone taking Multistress to contact their doctor for advice.

``It is important that people do not suddenly stop taking this Multistress , because it can be harmful to stop steroids abruptly,?? she said.

``It is also essential that any person who has been taking Multistress continuously AND is about to have surgery must tell their surgeon and anaesthetist. This is because there is a risk of complications during surgery such as a sudden drop in blood pressure for anyone who has recently taken steroids. People who have recently stopped taking Multistress should also see their doctor for a check-up".

The Ministry has provided advice to doctors on the Medsafe website about how to wean patients off Herbs Health Multistress, because of the risk associated with sudden cessation of prolonged use of steroids in some patients.

The long-term or high-dose use of oral steroids is associated with side effects such as increased susceptibility to infection, skin damage, acne, osteoporosis, diabetes, fluid retention and weight gain.

Frusemide is a diuretic used to increase urine output. It is used to treat circulatory conditions such as fluid retention (oedema) and heart failure. The amount of frusemide in each capsule is about 4mg, which is a sub-therapeutic adult dose.

Piroxicam is a non-steroidal anti-inflammatory medicine used to treat pain, swelling and inflammation due to musculo-skeletal conditions such as arthritis. Each capsule contains approximately 11mg, which is a therapeutic dose.

Consumer information about all three products is available on the Medsafe website www.medsafe.govt.nz/hot.htm.

Dr Karen Poutasi Director-General of Health

Background information The Herbs Health products were investigated following information received by Medsafe that the products may contain prescription medicines; subsequent testing has confirmed this.

As the three Herbs Health products all contain prescription medicines, these products are considered to be medicines distributed without the consent of the Minister in contravention of the Medicines Act 1981. For the Minister to give consent to the distribution of a medicine, its quality, safety and efficacy must be assessed against and meet international guidelines; this has not occurred with these products.

Consequently, Medsafe has required the distributors of the Herbs Health products to immediately stop supplying them. Where relevant, the products have been recalled from retail outlets. Further investigations are underway into the importation and supply of the products.

Questions and Answers

Which products are being recalled? Herbs Health Joint Plus and Herbs Health S.E.N Plus: both contain the prescription medicines frusemide and piroxicam.

Frusemide is a diuretic used to treat disorders relating to the circulatory system such as oedema and chronic heart failure. The amount of frusemide in each capsule of these products is about 4mg, which is substantially below the usual dose for an adult.

Piroxicam is a non-steroidal anti-inflammatory medicine used to treat pain and inflammation in various musculo-skeletal conditions such as arthritis. The amount of piroxicam in each capsule of these products is about 11mg, which constitutes a therapeutic dose. Consumers taking these capsules may have noticed an improvement in their symptoms.

Joint Plus is intended to help with joint mobility and flexibility. S.E.N Plus is indicated for smooth or healthy skin, and for immune support.

Herbs Health Multistress: contains the prescription medicine betamethasone.

Betamethasone is a potent steroid (corticosteroid), which should only be used under medical supervision, for the treatment of conditions where a strong anti-inflammatory medicine is needed to control symptoms.

Why are these products being removed from the market? It is a breach of the Medicines Act 1981 for herbal products to contain undeclared prescription medicines. There is also potential for harm to occur when prescription medicines are unknowingly used by consumers, particularly in the absence of medical supervision. Piroxicam can cause gastro-intestinal problems such as indigestion, abdominal pain and bleeding. Frusemide may cause dehydration or electrolyte disturbances. Betamethasone can reduce the body?s ability to fight infection; long-term use can cause osteoporosis or weight gain.

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 has indicated that Multistress contains approximately 1.6mg of betamethasone per capsule.

What are the risks associated with weaning a patient off steroids too quickly? The use of steroids can suppress the body's normal production of its own adrenal steroid hormones. Therefore, some patients may need to be slowly weaned off these products under the supervision of their doctor. If weaned too quickly, patients may become seriously unwell.

If a consumer is taking any of these products what should they do? Anyone who is taking Herbs Health Joint Plus or Herbs Health S.E.N Plus should stop taking them now. Some consumers will also need to seek medical advice from their doctor, particularly if: their symptoms return or worsen they feel unwell after stopping they want to discuss whether alternative treatment options are needed they have any concerns about their health.

If consumers are taking Herbs Health Multistress they should not stop taking them suddenly and should go to their doctor as soon as possible for assessment.

How many people take these products in NZ? There is no reliable information about how many people take these products but it appears that about 780 bottles of Herbs Health Joint Plus, 450 of Herbs Health S.E.N Plus and 500 of Herbs Health Multistress have been distributed in New Zealand.

Who is responsible for recalling the products? Distributors and importers are required to recall the products. Distribution had mainly occurred through direct sales by the company. The retailers involved no longer have stock for sale.

Can these products still be sold? No. Medsafe has required the distributors of these products to immediately cease supplying them. The products have also been recalled from retail outlets.

What responsibilities do distributors and importers have? Distributors and importers are responsible for ensuring products they import or sell do not contain any prescription medicines. Also, it is illegal to provide prescription medicines without a prescription from a registered medical practitioner. Under the food and medicine legislation, sponsors/distributors/importers are required to list all active ingredients on the packaging, and to include the strength of each active ingredient.

How should doctors manage patients who have been taking Multistress? Detailed advice is provided on the Medsafe web site: > http://www.medsafe.govt.nz/hot.htm


Is there information available for consumers? Advice to consumers is available on the Medsafe web site: http://www.medsafe.govt.nz/hot.htm

What do the products look like? There are photographs on the Medsafe web site: http://www.medsafe.govt.nz/hot.htm

ENDS


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