Tag Archives: US Food and Drug Administration

Anti-ageing Creams Could Cause Cancer

Anti-ageing creams, which promise to smooth away the fine lines of maturity, could lead to cancer by stripping the skin of its protective top  as explained by exparts.

A leading US professor has said that using these revolutionary creams could expose the skin to dangerous toxins and make it more prone to sun damage.

Dr Sam Epstein, chairman of the Cancer Prevention Coalition, has said that popular ingredients in anti-ageing creams called alpha-hydroxy acids (AHAs) were “probably the most dangerous cosmetic products on the market”.

And now, he has urged the American safety body to introduce new regulations to protect consumers and also asked British shoppers to be aware of the risks. “So many women, and even some men, slather these products all over their skin in the naive belief that they have nothing to fear but ageing,” The Daily Express quoted Epstein as saying.

The British cosmetics industry must comply with EU rules on what ingredients to use and what warnings to place on labels.

Currently, there is no requirement for a warning to be placed on creams containing AHAs.
However, Epstein pointed out that in America, the US Food and Drug Administration warned consumers that AHAs “could destroy the upper layers of skin, causing severe burns, swelling and pain”.

But he said that the dangers are equally relevant to British anti-wrinkle creams. “Anything that strips the surface of the skin not only risks sunlight penetrating the exposed layer but also allows other toxic products in. All of the toxic effects are massively increased by AHAs,” he said.

Epstein also expressed concern about other ingredients commonly used in anti-ageing products, such as limonene. “Apart from being an irritant, it is a well documented carcinogen,” he said.

Sources: The Times Of India

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Garden Heliotrope

Botanical Name: Valeriana officinalis
Family  : Valerianaceae
Subfamily: Ulmoideae
Genus : Valeriana
Kingdom: Plantae

Common Names in Danish: Baldrian, Laege Baldrian
Common Names in Dutch:Valeriaan
Common Names in English:All Heal, Common Valerian, Garden Heliotrope, Garden Valerian, Garden-Heliotrope, Valerian
Common Names in French:Valériane
Common Names in German:Baldrian
Common Names in Italian:Amantilla, Baldriana, Erva Gatta, Valeriana
Common Names in Japanese:Kanakoso, Kesso
Common Names in Portuguese:Valeriana
Common Names in Romanian:Odolean, Valerian?
Common Names in Spanish:Valeriana

Habitat: Typically found at an altitude of 0 to 1,642 meters (0 to 5,387 feet).Grows in most of europe.Native to Europe and parts of Asia, Valerian has been introduced into North America. It is consumed as food by the larvae of some Lepidoptera (butterfly and moth) species including Grey Pug.

Description:
Annual or perennial herbs, rarely shrubs . Leaves exstipulate , opposite or in basal rosettes.The plant is  4-6′ tall. Inflorescence a dichasial cyme, often changing to monochasium , sometimes paniculate or capitate. Flowers usually small, zygomorphic, bisexual or unisexual by abortion . Calyx persistent , epigynous , rolled or unrolled in flower. Corolla tubular , salver – or funnel-shaped, usually gibbous at the base , 3-5-lobed. Stamens 1-4, epipetalous , alternating with the corolla lobes . Carpels 3, united ; ovary uni- or tri-locular, with only one fertile locule; ovule pendulous, anatropous ; style simple ; stigma simple or 2-3-lobed. Fruit an achene, with a wing, an awn or pappose calyx.

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Flowers: Bloom Period: June. • Flower Color: near white, pale pink, white

A family of 13 genera and over 400 species, chiefly confined to the temperate regions , with the exception of Australia and the Andes in S. America. Represented in Pakistan by 3 genera and about 22 species

You may click to see :->How to grow Garden Heliotrope

Biochemical composition:
Known pharmacologically active compounds detected in valerian extract are:

*Alkaloids: actinidine, catinine, valerianine, and valerine
*Isovaleramide
*Gamma-aminobutyric acid (GABA)
*Valeric acid
*Valepotriates, acevaltrate, isovaltrate and valtrate
*Volatile oil containing active sesquiterpenes (acetoxyvalerenic acid, valerenic acid)
*Flavanones such as hesperidin, 6-methylapigenin and linarin
.

Medicinal Uses:
Heliotrope’s botanical name comes from the Latin, valere, which means “to be well”. In the first century, Dioscorides, a Greek physician in service to the Romans, described its pharmaceutical properties. Recent research in Germany and Switzerland shows that valerian encourages sleep, improves sleep quality and lowers the blood pressure. The valepotriates reduce nervous activity by prolong the action of an inhibitory neurotransmitter.

Valerian, in pharmacology and phytotherapic medicine, is the name of a herb or dietary supplement prepared from roots of the plant, which, after maceration, trituration, dehydration processes, are conveniently packaged, usually into capsules, that may be used for certain effects including sedation and anxiolytic effect.

The amino acid Valine is named after this plant.
Valerian is used for insomnia and other disorders and can be a useful alternative to benzodiazepine drugs.

In the United States Valerian is sold as a nutritional supplement. Therapeutic use has increased as dietary supplements have gained in popularity, especially after the Dietary Supplement Health and Education Act was passed in 1994. This law allowed the distribution of many agents as over-the-counter supplements, and therefore allowed them to bypass the regulatory requirements of the Food and Drug Administration (FDA).

Valerian is used against sleeping disorders, restlessness and anxiety, and as a muscle relaxant. Valerian often seems only to work when taken over longer periods (several weeks), though many users find that it takes effect immediately[citation needed]. Some studies have demonstrated that valerian extracts interact with the GABA and benzodiazepine receptors. Valerian is also used traditionally to treat gastrointestinal pain and irritable bowel syndrome. However, long term safety studies are missing. Valerian is sometimes recommended as a first-line treatment when benefit-risk analysis dictates. Valerian is often indicated as transition medication when discontinuing benzodiazepines.

Valerian has uses in herbal medicine as a sedative. The main current use of valerian is as a remedy for insomnia, with a recent meta-analysis providing some evidence of effectiveness. It has been recommended   for epilepsy but that is not supported by research (although valproic acid, an analogue of one of Valerian’s constituents (valeric acid), is used as an anticonvulsant and mood-stabilizing drug). Valerian root generally does not lose effectiveness over time.

While shown to be an effective remedy for the reduction of anxiety, it has also been reported to cause agitation, headaches and night terrors in some individuals. This may be due to the fact that some people lack a digestive conversion property necessary to effectively break down Valerian. One study found that valerian tends to sedate the agitated person and stimulate the fatigued person, bringing about a balancing effect on the system.


Oral forms, usage and adverse effects

Oral forms
Oral forms are available in both standardized and unstandardized forms. Standardized products may be preferable considering the wide variation of the chemicals in the dried root, as noted above. When standardized it is done so as a percentage of valerenic acid or valeric acid.

Usage
Dosage is difficult to determine due to the lack of standardization and variability in available forms. Typical dosages of the crude herb vary from 2-10 grams per day. Valerian root is non-toxic but may cause side effects in large excessive doses.


Adverse effects

Few adverse events attributable to valerian have been reported. Large doses (500+ mg) or chronic use may result in stomach ache, apathy, and a feeling of mental dullness or mild depression. Because of the herb’s tranquilizer properties, it may cause dizziness or drowsiness, effects that should be considered before driving or operating heavy or hazardous equipment.  In some individuals, valerian can cause stomach ache, anxiety, and night terrors (see above). Though some people like the earthy scent, many others find it unpleasant. Overall, Valerian generally comes with very mild side effects and is considered a safe dietary supplement. In rare cases, Valerian may cause an allergic reaction, typically as a skin rash, hives, or difficulty breathing.

Effect on cats and rats
An unusual feature of valerian is that the essential oil of valerian root is a cat attractant similar to catnip. The active compound in valerian for this is actinidine. Cat attractants might mimic the odor of cat urine which is caused by 3-mercapto-3-methylbutan-1-ol (MMB). Anecdotes state that valerian is also attractive to rats, so much so that it had been used to bait traps. Some versions of the legend of the Pied Piper of Hamelin have him using valerian, as well as his pipes, to attract the rats.[5] This might be related to the change of aversion into attraction to cat urine in rats infected with the parasite Toxoplasma gondii.

Valerian’s effect on cats is featured as a clue in two works by Agatha Christie.

CLICK &  LEARN MORE ABOUT HELIOTROPES

Disclaimer:The information presented herein is intended for educational purposes only. Individual results may vary, and before using any supplements, it is always advisable to consult with your own health care provider.

Resources:
http://zipcodezoo.com/Plants/V/Valeriana_officinalis/
http://www.piam.com/mms_garden/plants.html

http://en.wikipedia.org/wiki/Valerian_(herb)

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Microwaves Harmful During Pregnancy

It is hard to believe but true that the microwave oven you use to make food could be harmful to your unborn child, especially when the device is old or is wrongly used. Tests have shown that microwaves emit harmful electromagnetic radiation which could harm embryos and could lead to miscarriage.

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Microwaves can be harmful if they are leaking radiation,” says Dr Shivani Sachdev Gaur of Phoenix hospital. The waves of a microwave oven can travel up to 12 cm, so it is harmful for a pregnant woman to stand near a microwave oven, especially if it is old and damaged, she says.

If the door of the oven is damaged or if the user uses it with the door opened, then the leakage is more. In old microwave ovens the leakage levels of radiation could be more.

A survey conducted among Professional Service Associates, a group of US microwave repair servicemen, indicated that over 56 per cent microwave ovens two years or older leaked levels of radiation 10 per cent higher than the safety standards set by the FDA.

These radiations may lead to cell death, infertility, malnourished babies, damaged DNA and even miscarriages.

Source: The Times Of India

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FDA Warns Consumers Not to Use Hydroxycut Diet Supplements

The manufacturer recalls most of the popular weight-loss supplements after the FDA reports some have been linked to serious liver injuries, one causing a death.

The Food and Drug Administration has issued a warning to consumers to stop using Hydroxycut dietary supplements because some have been linked to serious liver injuries, with one death reported to the agency.

Iovate Health Sciences Inc. is recalling most of its Hydroxycut products from the market. The popular, heavily advertised supplements promise weight loss and include such products as Max Drink Packets, Caffeine-Free Rapid Release Caplets and Max Aqua Shed. Hydroxycut Cleanse and Hoodia products are not part of the recall.

The recalled products contain several ingredients, among them herbal extracts, although the FDA said it’s not sure which ingredients or dosages could be causing the problems.

Unused products should be returned to where they were purchased.

One death caused by liver failure was reported to the FDA, plus 23 instances of severe health problems — including jaundice, elevated liver enzymes, liver damage (requiring a transplant), seizures and cardiovascular disorders.

Liver injury symptoms include jaundice, brown urine, excessive fatigue, stomach or abdominal pain, and nausea.

Although the FDA says that bad reactions are rare, anyone using the products should stop immediately.

Sources
: Los Angeles Times

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Rapid Detection of Infectious Diseases.

Only a few minutes and a simple, ready-to-use diagnostic test kit are needed to determine an individual’s infectious disease status.
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In about the middle of the 20th century, mass vaccination programs and the widespread availability of antibiotics significantly reduced the threat of infectious diseases in Canada and many other regions of the world. Indeed, a concerted worldwide effort led to eradication of the smallpox virus, the cause of the most serious infectious disease in the western world during the 17th and 18th centuries , and the incidence of other diseases, such as the common childhood ailments measles, mumps, and pertussis, have been reduced by similar vaccination programs . Despite these advances, however, infectious diseases remain the world’s leading cause of premature death, accounting for about 17 million deaths in 1995.

To further control communicable diseases, global efforts must overcome ongoing challenges provided by the evolution of infectious agents. Among the more significant evolutionary changes in the past 25 years are the increased prevalence of antibiotic resistance in infectious bacteria (e.g., methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE))  and the emergence of about 30 new infectious agents (e.g., human immunodeficiency virus (HIV), hepatitis C virus (HCV), and the ebola virus) . Moreover, rapid evolutionary changes create new appearances for some infectious agents (e.g., the influenza virus and HIV), allowing them to circumvent the defensive mechanisms of our immune systems.

Another obstacle for the control of communicable diseases arises when the role of an infectious agent in a disease goes unnoticed. The significance of this point was demonstrated in the 1980s when the bacterium Helicobacter pylori was finally recognized as a causative factor of duodenal ulcers and other gastric diseases . As a result of the H. pylori discovery, many gastric diseases are now effectively treated with antibiotics, and it is possible that new therapeutic directions will be stimulated by a recent proposal, which implicates chronic infections as a cause of several well-Known diseases (e.g., atneroscierosis and Alzheimer’s Disease).

For infectious diseases, an unambiguous diagnosis obtained in a timely fashion is extremely important, not only from a personal viewpoint (i.e., the initiation of an appropriate treatment), but also from a public health perspective (i.e., the prevention of disease transmission from one individual to another).

To a large extent, evidence for the presence of an infectious agent, and thus the diagnosis of infectious disease status, is provided by the results of one or more diagnostic tests. In addition to providing an accurate result, an ideal rapid diagnostic test should be easy to perform while yielding a definite result within a reasonable length of time ([less than]30 min to be considered as a rapid test).

For these reasons, most rapid diagnostic tests for infectious diseases are based on the highly selective, noncovalent interactions between an antibody and an antigen. Antibodies are proteins produced by the immune system in response to the entry of a foreign entity, such as an infectious agent. Because antibodies specifically bind to a distinct site (or epitope) in a protein or another macromolecule (i.e., the antigen) associated with the infectious agent, the unique group of antibodies generated during each infection is an excellent diagnostic marker for disease. This immunoassay approach can be limited by the time required for antibody levels to increase to detectable levels after infection (e.g., antibodies for HIV are detectable on average 25 days post infection).

Immunoassays in various forms (e.g., enzyme immunoassays) are increasingly employed in clinical laboratories; however, the rapid test format is the most recent innovation in an industry undergoing substantial growth. In rapid tests, membrane immobilized antigens are used to capture the antibodies generated against the infectious agent. The specificity of a test towards a particular disease relies on the highly specific antigen-antibody interaction, and the appropriate choice of an antigen captures only the disease specific antibodies on the rapid test membrane. The appropriate antigen can be obtained from the infectious agent, produced by recombinant methods, or mimicked by synthetic peptides.

Antibodies captured by the membrane-immobilized antigen are detected using a colour reagent (e.g., protein A-colloidal gold or anti-human IgG antibodies conjugated to coloured particles), and a positive test typically is signified by the appearance of a coloured dot or line on the test membrane. If no disease antibodies are present in the sample, the colour reagent is not trapped on the membrane, and a negative result is obtained. A control dot or line often is included to verify that the colour reagent is functioning properly. While the rapid test format with visual interpretation provides only a qualitative result, a positive/negative result is sufficient in many diagnostic applications, including infectious disease diagnosis.

An immediate result provided by a rapid test is particularly advantageous when knowledge of a communicable disease is needed quickly (e.g., emergency surgery) or when a patient is apprehensive about the disease and might not make a second visit to a medical facility to receive the test result. The latter is a significant problem; about 30% of patients tested for HIV in publicly funded clinics in the United States during 1995 did not return , and a large cost is incurred by tracking them down to deliver the result of a laboratory test and to arrange a confirmatory test when a positive first result is obtained. The simplicity of the rapid test format allows the test to be used wherever an infectious disease has a high prevalence, or in remote clinical settings where patients must travel significant distances to get to the test centre.

The timeline from the initial idea to sales of an approved rapid diagnostic test is about five years. Over this period, research is undertaken to validate the concept; the optimum parameters are established for the immunoassay in the rapid test format, and in-house evaluation is conducted. The safety and effectiveness of the test is then established by independent clinical trials at several different locations before applications are submitted for regulatory approval by Health Canada and agencies in other countries, such as the Food and Drug Administration (FDA) in the United States. In April 1998, Health Canada granted its first approval for a rapid HIV test to MedMira Laboratories Inc.

MedMira is a publicly traded (CDNX: MIR) Canadian medical biotechnology company at the leading edge of rapid diagnostic test development. The company has expanded considerably since the early 1990s when it was established in Nova Scotia’s Annapolis Valley. At present, MedMira has over 45 employees and a corporate office in Toronto, ON. Separate locations for research and manufacturing are located in the Halifax Regional Municipality. In July 1999, MedMira Laboratories received International Organization of Standards ISO9001 registration designed around Health Canada’s ISO 13485 essentials for the manufacture of medical devices, and a system of product manufacturing compliant with the U.S. FDA current Good Manufacturing Practices (cGMP) was established and implemented at MedMira in April 1999.

In addition to the HIV test, which is able to detect HIV-1, HIV-2, and the rare group O variant of HIV-1, MedMira also has developed rapid tests for other infectious agents, including H. pylori, hepatitis B virus (HBV), HCV, and a HIV/HCV combination. The MedMira rapid tests meet the approval requirements in several countries and the approval process is underway in others. For example, the H. pylori test was granted U.S. FDA 510(k) clearance last year, and the U.S. FDA/PMA committee and the Chinese State Drug Administration (SDA) have accepted the MedMira HIV test for review. The MedMira test kits are marketed worldwide.

While the acute effects of infectious diseases are widely known, a connection between infectious agents and cancer has been established for HBV/HCV (liver cancer) , H. pylori (gastric cancer) , and human papillomaviruses (HPV) (cervical cancer) . Currently, rapid tests for infectious diseases identify certain underlying risk factors for cancer, but in the future, rapid test methodology will be available to detect markers associated with other forms of cancer.

Diagnostic tests are an integral part of modern health care. The availability of rapid diagnostic tests demonstrates that the complex interactions between molecules such as antigens and antibodies (and up-to-date science) can be utilized to provide a reliable diagnostic test in a simple format. Ongoing research is needed to keep rapid test methodology current with the evolution of infectious agents, and to expand the rapid test approach to the diagnosis of other diseases. Because of the simple format and reasonable cost, rapid test methodology holds the promise of bringing more efficient and effective diagnostic testing to both developed and undeveloped countries around the world.

Sources:http://www.allbusiness.com/north-america/canada/791219-1.html

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