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Poor Practice In The Unlicensed Herbal Sector - MHRA Warns The Public To Be Vigilant, UK

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Over recent months the Medicines and Healthcare products Regulatory Agency (MHRA) has seen continuing evidence of bad and dangerous practices across parts of the unlicensed herbal sector. All the cases reported have had a common theme: adverse reactions, or the potential for consumer harm. This has lead to the MHRA investigating and subsequently finding serious examples of very poor practice. Today we are warning the public about some of these practices by highlighting some of the most recent cases.

The issues found were:

- Reports of suspected adverse drug reactions, which were linked to an illegal unlicensed product being marketed for diabetes, which gave extremely dangerous advice to patients to stop taking prescribed medication. The MHRA took action to remove the product DBCare from the UK market (See notes to editors)

- A case of liver toxicity where two multi ingredient Traditional Chinese Medicine (TCM) products were being taken. This case highlighted the illegal practice of sticking a different label with a different list of ingredients on top of the original product label, so it's anyone's guess as to what the actual ingredient are!

- Poor sourcing practices i.e. buying from companies with bogus addresses and taking samples of unknown provenance from a 'travelling salesman' e.g. the case of Tian Li (See notes)

- Evidence of the adulteration of products with potent pharmaceuticals or toxic ingredients. This is a serious problem that is indicative of low grade manufacturing standards and in some cases a deliberate intention to deceive the public, e.g. Li Da Dai Hua a herbal slimming product which was found to contain Des methyl sibutramine (a POM)

Many unlicensed herbal medicines are not made to such low standards. The problem is that consumers have to guess whether these unlicensed products contain the ingredients that are declared, and have reliable information about their use.

Good news for consumers:

- The MHRA is looking to reduce these risks through the new traditional herbal registration scheme (THR), for manufactured over-the-counter traditional herbal medicines.

- Under this scheme products are required to meet assured standards of safety, quality and patient information. Agreed minor claims are permitted on the basis of evidence of traditional use.

- To date we have received, 35 applications to register herbal products from a total of 12 companies, covering a total of 17 herbs as the active ingredients. Eleven applications have so far been granted, to 2 companies; the remaining 24 applications are under assessment.

- We are expecting the number of applications received and registrations granted to increase steadily over the coming months as we move towards 2011 when transitional protection for certain existing unlicensed herbal medicines expires. More and more registered products (shown by the THR number on the label) will be coming onto the UK market and consumers wishing to take herbal medicines will be able to choose from a wide range of products made to assured standards. Licensed herbal medicines (shown by the PL number) meeting assured standards also continue to be available.

- The agency is committed to making it easier for consumers to find out how to use herbal medicines safely. Consumers looking for information on the safe use of herbals can view our advice on our website, which is regularly updated. See hyperlink.

Notes

Case studies


1. Two suspected adverse drug reactions reports have been received in association with in a multi-constituent Ayurvedic remedy, the product DBCare contained ingredients such as Trigonella foenum-graecum, Tinospora cordifolia, Syzygium aromaticum, Phyllanthus emblica. This product claimed to allow patients to stop taking their prescribed diabetic medicines. One patient experienced loss of diabetic control and the other patient experienced liver problems, increased blood glucose and increased blood pressure. Due to the very serious nature of the claims made on this illegal product, the Agency took action, removing the product from the market and closing down the website selling the products.

2. A man collapsed after consuming a product called Tian Li, which claimed to give sexual enhancement. He was also taking Viagra on prescription. Whilst no permanent ill health was suffered by the consumer, the result of our analysis showed the presence of hydroxyhomosildenafil at a level of 39.6mg per capsule and tadalafil at 14.4mg per capsule. MHRA enforcement officers subsequently seized a quantity of the product from the supplier. As a result of our investigation it transpired that the company's warehouse was approached by a sales person selling packets of Tian Li, which were then supplied to about six of the company's retail outlets. MHRA were also alerted to wholesalers who are being regularly approached by salesmen trying to sell TCM products.

3. A woman who purchased a slimming product called Li Da Dai. She used this product for three days and felt a bit weak and vomited. She wasn't sure if these were side effects or not but had been on the internet and found the item on our website about Li Da Dai Hua reported by the Dutch authorities to contain Sibutramine. MHRA subsequently tested the product and confirmed the presence of Des methyl sibutramine (a POM).

4. A TCM direct marketing flyer for 'herbguo.com' was advertising it's herbal solution to Coronary Heart Disease. Saying they could replace a Coronary Heart Disease operation with a six week herbal treatment. The MHRA is currently investigating this case.

5. The Agency recently received a complaint from a clinician who has expressed concern that an Ayurvedic practitioner had advised a patient not to take his medicine for schizophrenia and instead go to India for other treatments.

The MHRA continues to seize, or receive from other agencies, for analysis a significant quantity of suspect herbal products. In recent months products being sold as herbal, natural and safe have tested positive for Aristolochia, Sildenafil, Tadalafil, Finasteride, Clotrimazole, Mebhydrolin, Nonivamide, Hydroquinone

Traditional herbal registration scheme

The first product to receive a registration was Atrogel Arnica Gel: an arnica gel traditionally used for the temporary symptomatic relief of muscular aches and pains, stiffness, sprains, bruises and swelling.

Since then we have registered

- Flexiherb ; a Devil's claw product traditionally used for the relief of backache, rheumatic or muscular pains and general aches and pains in the muscles and joints

- Migraherb ; a Feverfew product traditionally used for the relief of migraine and tension type headaches

- Menoherb ; A Black cohosh product traditionally used for the relief of symptoms of the menopause

- Prostasan ; a Saw Palmetto product traditionally used for the relief of symptoms associated with prostate enlargement in men such as frequent, difficult and incomplete urination

- Premherb ; an Agnus Castus product traditionally used for the relief of premenstrual symptoms

Niteherb ; a valerian product which is a traditional herbal medicine used for the temporary relief of sleep disturbances due to symptoms of mild anxiety.

- Atrosan Tablets ; a Devil's Claw product traditionally used an anti-inflammatory to relieve pain and inflamation in conditions such as rheumatism and osteoarthritis

- Venaforce ; a Horse Chestnut product traditionally used for the relief of symptoms associated with venous insufficiency and varicose veins, such as tired heavy legs, pain, cramps; swelling as well as restless legs and spider veins

- Hypericalm ; a St Johns Wort product traditionally used for the relief of symptoms of slightly low mood and mild anxiety

- Niteherb Plus ; a Valerian Roots Extract & Passiflora extract product which is a traditional herbal medicine used for the temporary relief of sleep disturbances due to symptoms of mild anxiety.

Progressively the MHRA will place assessment reports about these registered products on the website. Please see the hyperlink. As part of our on-going work to ensure that consumers are able to readily distinguish products registered under the scheme from other products on the market, we are developing an identifier symbol. Publicity concerning the identifier will be developed in 2008.

We have also made a number of improvements and updates to the herbal part of the website including adding an e-mail alerting facility to which users can subscribe and receive an e-mail notification when the Herbals Section of the website is updated.

http://www.mhra.gov.uk
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16:45 - 2008-Mar-31 - comments {0} - post comment


Foot Ulcer Types And Treatment Posted By : HutchPeter

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A skin ulcer is where an area of skin has broken down and you can see the underlying tissue. Most skin ulcers occur on the lower legs or feet. The skin normally heals quickly if it is cut. However, in some people with diabetes the skin on the feet does not heal so well and is prone to develop an ulcer. This can be even after a mild injury such as stepping on a small stone in your bare feet.

Types of Foot Ulcer

Venous ulcers are located below the knee and are primarily found on the inner part of the leg, just above the ankle.

The borders of a venous ulcer are usually irregularly shaped and the surrounding skin is often discolored and swollen. It may even feel warm or hot. The skin may appear shiny and tight, depending on the amount of edema (swelling). The skin may also have brown or purple discoloration about the lower leg, known as "stasis skin changes."

Neurotrophic (diabetic)

Neurotrophic ulcers are usually located at increased pressure points on the bottom of the feet. However, neurotrophic ulcers related to trauma can occur anywhere on the foot. They occur primarily in people with diabetes although they can affect anyone who has an impaired sensation of the feet.

Diabetes can cause damage to the nerve and vascular supply in the feet and legs. Patients with neuropathy have reduced or no sensation and, therefore, might be unaware of any trauma to their feet caused by ill-fitting footwear or an object in their shoes, such as a piece of glass, a stone or a drawing pin. Continued walking on an injured foot will damage it further and minor lesions can become more serious. A simple examination of the feet, feeling inside the shoes before wearing them and not walking barefoot can help to prevent minor injuries. Many of the patients attending the diabetes clinic are older and some cannot see, feel or reach their feet, which means that they are often unaware of any injuries.

Diabetic foot ulcers are caused by neuropathic (nerve) and vascular (blood vessel) complications of the disease.

Nerve damage due to diabetes causes altered or complete loss of feeling in the foot and/or leg. This is known as peripheral neuropathy. Pressure from shoes, cuts, bruises, or any injury to the foot may go unnoticed. The loss of protective sensation stops the patient from being warned that the skin is being injured and may result in skin loss, blisters and ulcers.

Treatment options for all ulcers may include:

Antibiotics, if an infection is present

Anti-platelet or anti-clotting medications to prevent a blood clot

Topical wound care therapies

Compression garments

As a rule, the better the control of your diabetes, the less likely you are to develop complications such as foot ulcers. Also, where appropriate, treatment of high blood pressure, high cholesterol level, and reducing any other risk factors will reduce your risk of diabetes complications. In particular, you are strongly advised to stop smoking if you smoke.

Our feet keep us balanced and carry our weight. In a lifetime they walk as much as going five times around the earth. We should look after our feet before any of these problems creep in. Some of the serious foot problems may need the attention of a doctor. So, prevention is always better than cure.


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20:13 - 2008-Mar-30 - comments {0} - post comment


Tobacco Poses Threat To Mothers In Developing World

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U.S researchers said that pregnant women's exposure to tobacco in developing countries is growing at an alarming rate.

Women in developing countries and their children are increasingly breathing secondhand smoke in their homes and many more are beginning to experiment with smoking, increasing the risk of cancer, heart disease and illness not only for themsevles but also for their children.

Dr. Michele Bloch of the National Cancer Institute's Tobacco Control Research Branch, whose study appears in the American Journal of Public Health said, "Pregnant women's tobacco use and exposure to secondhand smoke threaten to impede or reverse ongoing efforts to improve maternal and child health in the developing world."

The study is the first to examine pregnant women's tobacco use, exposure to secondhand smoke and attitudes about tobacco use in many developing countries.

It involved 8,000 interviews with pregnant women at 10 study sites in nine countries, including Argentina, Uruguay, Ecuador, Brazil, Pakistan, Zambia and the Democratic Republic of the Congo.

The researchers found as many as 18 percent of pregnant women smoked cigarettes, up to one-third used smokeless tobacco and as many as half regularly breathed in secondhand smoke.

Bloch said these trends represent a major shift among women in developing countries, where historically about 9 percent of women used tobacco, due in part to strong cultural taboos.

Smoking is the leading cause of preventable death among women in developed countries, and Bloch said the findings offer a chance to intervene before women in the developing world match that grim statistic.

She added, "Latin America is where the epidemic of cigarette smoking is most advanced, particularly in Uruguay, where 78 percent of all pregnant women said they had ever tried a cigarette. In Argentina, 75 percent of pregnant women interviewed said they had tried smoking."

Smokeless tobacco was used by a third of the women in the Indian state of Orissa, while the highest levels of secondhand smoke exposure was found in Pakistan.

"Young children in Pakistan are frequently or always exposed to tobacco smoke indoors. The numbers were also high in Argentina, Brazil, Uruguay and one of the Indian states."

http://www.ash.org
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12:49 - 2008-Mar-25 - comments {0} - post comment


Skin Care ?????“ How to Get Rid of Oily Skin

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Oily skin is shiny, thick and dull colored. Usually a chronically oily skin has boorish pores and pimples and other embarrassing blemishes. In this type of skin, the oil producing sebaceous glands are overactive and produce more oil than is required.

Oil glands are more normally known as sebaceous glands. In clinical terms, the oil, which is secreted by the sebaceous glands, is known as sebum. These glands secrete oil in the face, neck, chest and others parts of the body. But the nose is the region which is greately affected as lots of oil is secreted and agglomerated here. The pores in this area are larger and the oil then flows to most part of the face.

The amount of oil which is produced depends upon individual to individual. During teenage years, because of the increase in the level of sex hormones known as androgens, the sebaceous glands make more oil as these androgens increase and actuate the sebaceous glands. The extra sebum which is produced is the main reason of inflammation and acne. Oily skin can be due to heredity or hormone levels.

Commonly teenagers are plagued with oily skin and acne breakouts. But sometimes-oily skin can continue way into adult years. With age the stream of sebum decreases and the skin becomes less oily. Humidity levels can also be a cause for excess oiliness on the skin.

Oily skin is differentiated by shine and enlarged pores. On account of the high levels of sebum, the skin has a greasy gloss and tendency to break out into acne. The reason is that oily skin tends to attract more dirt and dust. Oily skin care second step is moisturizing. Instead of oil, our skin contains water, that is very important to all the skin functions.

Oily skin can, and very normally is, dehydrated. That means lacking water and the first signs of dehydrated skin are very fine lines, which form wrinkles. Oily skin moisturizers are especially formulated to not block pores. There are also specialty creams for oily skin which deals with eliminating black heads and preventing blackheads from forming again. In oily skin care third step is nourishing. This is normally the role of the night cream. Even oily skin wants antiaging products, which are applied at night. Eye creams are used at night or in the morning. Masks are very important and can be a part of the oily skin solutions.

Oily Skin Care Tips

??? Avoid using products on the face that add shine, like bronzers and shimmery blushes.
??? Use oil-free cosmetics and products made for oily skin.
??? A mixture of egg, camphor and skim milk powder can be take in action for oily skin.
??? Avoid reapplying powder throughout the day. A build-up of powder and makeup can contribute to clogged pores and blemishes.
??? Always remove your makeup before going to bed, but avoid cold creams and lotions, which may leave a greasy film on your skin.
??? After applying makeup, brush the entire T-zone with a loose, translucent powder.
??? Use an oil-free sunscreen with a minimum SPF of 15 when exposed to the sun.
??? Lavender is also powerful regenerative oil, antibiotic, antiseptic, and promote the prevention of scarring.

Ask a Question or Share Answers.You can also ask Health Questions and Answers at Discussion Forum. Girls can participate in Girls Forum

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12:43 - 2008-Mar-19 - comments {0} - post comment


Eucalyptus - Uses and Side Effects By Ricky Hussey

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Eucalyptus oil, also known as eucalyptol, is steam-distilled from the twigs and long leathery leaves of the eucalyptus tree. Eucalyptus folium contains the dried leaves of older Eucalypti globulus trees. The leaves are collected after the tree has been cut down and allowed to dry in the shade. The primary component of eucalyptus oil is the volatile substance 1,8-cineol (cineole). Oil preparations are standardized to contain 80% to 90% cineole.

The effectiveness of the herb as an expectorant is attributed to the local irritant action of the volatile oil. Eucalyptus is available as dried herb, eucalyptus leaf, essential oil, and tea bags.

Reported uses

Eucalyptus is used internally and externally as an expectorant, and to treat infections and fevers. It's also used topically to treat sore muscles and rheumatism. A topical combination of eucalyptus and peppermint shows promise as an analgesic.

Administration

Essential oil: Used in massage blends for sore muscles, in foot baths or saunas, steam inhalations, chest rubs, room sprays, bath blends, and air diffusions; for external use only

Leaf: Average daily dose is 4 to 16 g by mouth every 3 to 4 hours

Oil: For internal use, average dose is 0.3 to 0.6 g by mouth every day

Tea: For infusion, steep 6 oz of dried herb in boiling water for 2 to 3 minutes, and then strain; for decoction 6 to 8 oz of dried herb boiled for 3 to 5 minutes

Tincture: Take 3 to 4 g by mouth every day.

Hazards

Adverse reactions may include nausea, vomiting, diarrhea, and asthma-like attacks. Enhanced effects may be noted when administered with antidiabetics. Eucalyptus oil induces detoxification enzyme systems in the liver; therefore, the oil may affect any drug that the liver metabolizes. When given with other herbs that cause hypoglycemia (basil, glucomannan, Queen Anne's lace), decreased blood glucose levels may be observed.

Patients who have had an allergic reaction to eucalyptus or its vapors should avoid use. Those who are pregnant or breast-feeding, have liver disease, or have intestinal tract inflammation should avoid use.

Safety Risk Essential oil preparations shouldn't be applied to a child's face because of risk of severebronchial spasm.

Clinical considerations

Inform patient of potential adverse effects.

Monitor patient for allergic reaction.

In susceptible patients, particularly infants and children, the application of eucalyptus preparations to the face or the inhalation of vapors can exacerbate bronchospasm.

Monitor blood glucose level in diabetic patients taking eucalyptus.

Oral administration may cause nausea, vomiting, and diarrhea.

If poisoning or overdose occurs, don't induce vomiting. Vomiting may increase the risk of aspiration. Administer activated charcoal and treat symptomatically.

Advise the patient to stop taking eucalyptus immediately and to check with health care provider if difficulty breathing, hives, or skin rash occur.
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16:24 - 2008-Mar-18 - comments {0} - post comment


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