Tongqiao Biyan Pian

Canadian authorities issue a recall for Pollen Allergy now called Tongqiao Biyan Pian

The Canadian authorities have issued a recall for Pollen Allergy now called Tongqiao Biyan Pian.

Product name

Pollen Allergy now called Tongqiao Biyan Pian

Product description

Pollen Allergy or Tongqiao Biyan Pian is marketed as a natural health product for the treatment of allergies. It is used for rhinitis, allergies, chronic rhinocleeisis, rhinorrhea, sneezes and coughs.

Reason for warning

Health Canada has issued a recall from the Canadian market after testing found levels of arsenic that exceed limits allowed by Health Canada. The product was also found to contain two undeclared pharmaceutical ingredients in low amounts. It contained chlorphenamine (an antihistamine) and paracetamol (called acetaminophen in the USA and Canada). None of these ingredients are listed on the label.

Possible side effects:

For pregnant women, consumption of products with arsenic may increase the risks of pre-term birth, stillbirth or miscarriage. Children and adults who are exposed to arsenic may experience side-effects such as stomach pain, vomiting, diarrhoea, muscle cramping, weakness, skin rash, numbness or tingling and loss of movement.

It is vitally important that all ingredients are declared on the label to avoid the risk of possible allergic reactions in consumers with known allergies to chlorphenamine or paracetamol. In addition, consumers may have been unknowingly at risk of a paracetamol overdose if they were taking other products containing paracetamol.

Antihistamines, such as chlorphenamine, are not recommended for use in children less than six years of age.

It is unclear whether these products are available in retail outlets in the UK but could be available on the internet.

Recall of Viridian Black Cohosh Root capsules

In response to an urgent notice issued by the MHRA, 

Viridian Nutrition has agreed torecall stocks of Black

Cohosh Root Capsules, as some batches of the product have

been found to contain an undeclared plant species in 

addition to the declared plant species.

Shark Essence

Advice to consumers not to use Shark Essence, a herbal medicine used to treat erectile dysfunction

The MHRA is advising consumers not to use the product specified below due to concerns about possible side-effects.

Product name

Shark Essence

Product description

Shark Essence is marketed as a herbal medicine that treats sexual dysfunction.

Reason for warning

The MHRA has received advice from the Ministry of Health, Jerusalem warning that this unlicensed product has been tested and found to contain Tadalafil and Sildenafil which are Prescription Only Medicines used in the treatment of male erectile dysfunction. These active ingredients are not listed on the product label.

Possible side effects:

Tadalafil is the active ingredient in a Prescription Only Medicine called Cialis and should only be used when prescribed by a doctor. Uncontrolled consumption of Tadalafil is dangerous and could potentially cause serious adverse reactions such as heart attack, stroke and severe hypotension.

Sildenafil is the active ingredient in a Prescription Only Medicine called Viagra and should only be used when prescribed by a doctor. Uncontrolled consumption can cause potentially life-threatening high blood pressure. Individuals with heart problems are at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain and abnormal heart beat. Other side effects include headache, indigestion, dizziness and abnormal vision.

It is unclear whether these products are available in retail outlets within the United Kingdom but could be available on the internet.

Ultra Slim For Slimming

Advice to consumers not to use Ultra Slim, a herbal slimming product

The MHRA is advising consumers not to use the product specified below due to concerns about possible side-effects.

Product name

Ultra Slim

Product description

The product is in capsule form, it is advertised as a natural weight loss product based on a Chinese herb formula called DaiDaiHua. This product was shipped from the USA. MHRA have also issued a previous alert about DaiDaiHua.

Reason for warning

The MHRA has received advice from the Danish Medicines Agency that this unlicensed product have been tested and found to contain the Prescription Only Medicine Sibutramine which was withdrawn from the market in January 2010, on safety grounds, due to increased risk of heart attacks and strokes.

It is unclear whether these products are available in retail outlets but could be available on the internet.

Possible side effects

Sibutramine has been withdrawn from the EU market, due to increased risk of heart attacks and strokes.

Black Cohosh Root capsules

People asked to return Black Cohosh Root capsules made by Viridian Nutrition

People who use herbal products are being asked to check if they have any ‘Black Cohosh Root’ capsules that are made by Viridian Nutrition in their homes. If they do, people should return the product to where they bought it because the product has been found to contain an unintended and undeclared plant material.

The Medicines and Healthcare products Regulatory Agency (MHRA) has taken action to request that the manufacturer Viridian Nutrition also recalls their ‘Black Cohosh Root’ capsules from sale in health shops. The manufacturer stopped marketing this product in July but some stock of the product may still be being sold.

Testing found that the product, which should only contain Black Cohosh (Cimicifuga racemosa), also contained another species, most probably Cimicifuga foetida. The undeclared plant material, Cimicifuga foetida, is not generally used in Western herbal medicine and its properties or safety has not been evaluated. This means that the product is not what is says it is or of the quality required and must be removed from the market.

David Carter, Manager of the MHRA’s Medicines Borderline Section said: “We expect a product to list all the correct ingredients on the label. In this instance they were not fully listed and, therefore, the product does not meet the standards required for public use. That is why we have told the company to recall the product from retailers and also to ensure that the recall is communicated to members of the public.”

The MHRA always recommends that registered herbal products are used. Registered products can be identified by the Traditional Herbal Registration (THR) registration number or logo on their packaging. These products have been assessed and quality checked to ensure that they are acceptably safe to use and are accompanied by a leaflet with information on how to use the product with possible side effects listed.

Herbal remedies should be used with the same caution and care as any other medicine as their use will have an effect on the body. While many herbal remedies are reasonably safe, it is important to remember that just because it contains natural ingredients and extracts this doesn’t guarantee it is safe. People should always consult with a pharmacist or doctor to make sure that an herbal remedy is suitable for them to take and will not interact with any other medicines they may be taking.

Prostasan Saw Palmetto Capsules by A.Vogel

Healthspan Ltd complained to the MHRA about an E-mail advertising Prostasan produced by A.Vogel and sent to consumers in June 2012. The complainant was concerned that the E-mail made claims for efficacy for Prostasan and promoted it for a use outside of its licensed indication as a traditional herbal remedy.

Herbal Medicines and Warfarin

Herbal products can be sold without evidence that they produce the desired clinical results.

While herbal products can provide benefits, there are many that do not work well with warfarin. Some herbs may put you at higher risk for bleeding complications, and some may make you more prone to developing clots.

Safety 
Herbal products may cause adverse reactions, just like traditional medicines can. The short- and long-term effects of herbal products have not been studied. The safety of these products for children, pregnant women, the elderly, and other special populations is not 
known. Those who have allergies, especially to plants or pollen, should use caution when using any herbal medicine. 


Herbal Products and Warfarin
Herbal products, just like many foods and drugs, may interact with warfarin. Many herbals contain substances that are similar to warfarin and may put you at a higher risk for bleeding complications. There are also herbal products that work against the actions of warfarin and can make you more prone to developing clots. 

Talk with your pharmacist about any herbal products you are thinking about taking while you are on warfarin to make sure you are not putting your health at risk. The tables below lists some common herbs that can either increase your risk of bleeding or increase your risk of forming blood clots. These herbs should not be taken while you are on warfarin. 

Signs of Bleeding Complications

• Unusual bleeding from gums
• Prolonged nose bleeds
• Red or dark urine
• Bruises that do not go away
• Coughing up,  vomiting, or spitting up blood

Warning Signs of Blood Clots 

• Sudden  numbness or weakness of the face, arm or leg, especially on one side of the body
• Sudden confusion
• Trouble speaking or understanding
• Sudden trouble in seeing in one or both eyes
• Sudden trouble walking, dizziness, loss of balance or coordination
• Sudden severe headache with no known cause

Herbs That Can Increase Risk Of Bleeding

Agrimony	Dandelion	Onion
Alfalfa	Danshen	Papain
Aniseed	Dihydroepiandrosterone	Parsley
Arnica flower	Dong quia	Passionflower
Artemesia	Fenugreek	Prickly Ash
Asafoetica	Feverfew	Poplar
Bochu	Fish oil	Quassia
Bogbean	Garlic	Red clover
Bromelains	Ginger	Sweet clover
Capsicum	Gingko	Sweet woodruff
Cassio	Horse chestnut	Tonka beans
Celery seed	Horseradish	Tumeric
Chamomile	Licorice	Wild carrot
Chinese wolfberry	Meadowsweet	Wild lettuce
Clove	Melilot	Willow

Herbs That Can Increase Risk Of Blood Clots

Coenzyme	Goldenseal	St. John’s wort
Ginseng	Green tea	Yarrow

Ramlostan Forte Safety Warning

The Austrian authorities have issued a warning for Ramlostan Forte manufactured by SC Parapharm, Romania. Ramlostan comes in white and blue packaging, with a picture of a ram at the top. Inside, there are ten blue capsules.

The Austrian authority (AGES) has issued a warning for this product after finding it to contain Tadalafil, a Prescription Only Medicine used in the treatment of erectile dysfunction and Yohimbe, a medicinal herbal ingredient. Neither of these ingredients were declared on the packaging.

Tadalafil is the active ingredient in a Prescription Only Medicine called Cialis and should only be used when prescribed by a doctor. Uncontrolled consumption of Tadalafil is dangerous and could potentially cause serious adverse reactions such as heart attack, stroke and severe hypotension.

Yohimbe can be toxic and cause panic attacks, high blood pressure, headache, nausea, paralysis, renal failure, seizure and death.

It is unclear whether these products are available in retail outlets in the UK but could be available on the internet.

Echinicea For Children Under 12 Years

Don't Give Echinacea To Children, Warns MHRA

The MHRA is advising parents and carers not to give oral products containing Echinacea to children under 12 years of age due to the risk of rare allergic reactions that may sometimes be severe. Echinacea species are herbal ingredients traditionally used mainly to relieve symptoms of the common cold and influenza type infections.

Echinacea & Golden Root for Juniors

MHRA takes Holland & Barrett’s Echinacea & Golden Root off the market

A herbal remedy sold by Holland and Barrett for young children and adolescents is being taken off shelves because the product is unlicensed, is labelled incorrectly and the claimed herbal ingredients present are incorrectly described. There are concerns that this product may not be suitable for use in children and adolescents and may cause unwanted side effects.

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked Holland and Barrett to stop marketing Herbal Authority: Echinacea & Golden Root for Juniors. Holland and Barrett have agreed to do this.

The pictures on the product do not match the labelling description and appears to show Goldenseal root (Hydrastis canadensis) and not Golden root (Rhodiola rosea). The botanical name on the product Berberis aquifolium is also incorrect.

This Holland and Barrett herbal product is not registered under the traditional herbal registration (THR) scheme, which is a scheme to help consumers be confident that the herbal remedies they are taking have been assessed for quality, safety and good manufacturing.