News Letter February, 2009

News Letter

Zhion's News Letter                                     April 30, 2009
                                                        Issue No.: 00004
__________________________________________________
Story of The Month:
Don't think resveratrol 100% safe!

Some rat-studies suggest that resveratrol is safe at doses equivalent to 300-
500 mg./day for short-term use. [4,5] The toxicity of prolonged intake of
resveratrol is unknown, especially at high doses. It has been speculated that
the side effects of oral intake of resveratrol include issues in collagen
formation and nerve regeneration, or even heart failure. This unwanted toxic
side effects are probably related to overdoses and prolonged use of
resveratrol. In general, the toxic effect of most drugs or supplements mostly is
caused by over-dosage, immediate absorption of large amount of active
ingredient at a time or prolonged use.

In various cancer cell lines, the copper concentration is reported to be
elevated. Resveratrol has also been shown to exhibit "prooxidant properties"
in the presence of copper ions. In a study of 2005, plasmid bluescript SK(+)
DNA was treated with increasing concentrations of resveratrol in the presence
and absence of copper ions, transformed into competent DH5alpha cells and
sequenced. The study shows a decrease in the transformation efficiency of the
plasmid after resveratrol treatment, and although all types of mutations were
recorded, point mutations (deletions/substitutions) were found to be the
predominant ones. Resveratrol alone resulted in deletion of mainly guanine
bases. In the chromatin of nucleus, copper ions are bound to guanine bases.
This study suggests the mobilization of such endogenous copper by resveratrol
resulting in "prooxidant DNA cleavage" at the site. Since the copper
concentration is high in various cancer cell lines, this may explain the
anticancer activities of resveratrol. [6]

Resveratrol is generally considered as a copper chelator. Thus, it is speculated
that oral intake excessive amount of resveratrol orally may hinder the
absorption of certain metal ions, especially copper ion, leading to copper
deficiency. People with ischemic heart disease usually have decreased cardiac
and leucocyte copper. It was found that copper deficiency decreases copper in
hearts and other organs and cells and increases cholesterol in plasma.
Abnormal physiology from deficiency includes abnormal electrocardiograms,
glucose intolerance and hypertension.

Most commercial supplements are immediate-release or immediate-
disintegrate dosage forms. Once, the users intake the supplements, the tablets
or capsules disintegrate and release the actives within a short period of time.
This sudden availability of a large amount of resveratrol in the gastric intestine
tract can prevent the absorption of the copper and potentially lead to copper
deficiency.

If this speculation is the case, the side effect of resveratrol is serious. Users
may need to take copper supplements. Talk to your doctor before taking any
supplements.

STORIES AROUND US

New salmonella outbreak connected to alfalfa sprouts
The Food and Drug Administration is recommending consumers not eat raw
alfalfa sprouts until further notice because the popular crunchy greens have
been linked to a salmonella saintpaul outbreak in Nebraska, South Dakota,
Iowa, Kansas, and Minnesota. [Alfafa sprout warning issued USA Today April 27,
2009]

Bleach Bath Helps Eczema
In a study of 31 children, Dr Amy Paller, from Northwestern University found a
significant improvement in eczema in those who had diluted bleach baths
compared with normal baths. But, this treatment could be extremely dangerous.
['Bleach bath' benefit for eczema, BBC, Monday, 27 April 2009]

Swine flu
Swine Influenza (swine flu) is a respiratory disease of pigs caused by type A
influenza viruses that causes regular outbreaks in pigs. People do not normally
get swine flu, but human infections can and do happen. Symptoms resemble
those of the regular flu, including sore throat, coughing and fever.

CDC has determined that this swine influenza A (H1N1) virus is contagious
and is spreading from human to human. Flu viruses are spread mainly from
person to person through coughing or sneezing of people with influenza.
However, at this time, it not known how easily the virus spreads between
people.

Laboratory testing has found the swine influenza A (H1N1) virus susceptible
to the prescription antiviral drugs oseltamivir and zanamivir and has issued
interim guidance for the use of these drugs to treat and prevent infection with
swine influenza viruses.

http://cdc.gov/swineflu/swineflu_you.htm

FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and
Fever Reducers to Help Consumers Use Products Safely (April 28)
The Food and Drug Administration issued a final rule today that requires
manufacturers of over-the-counter (OTC) pain relievers and fever reducers to
revise their labeling to include warnings about potential safety risks, such as
internal bleeding and liver damage, associated with the use of these popular
drugs.

Raw Alfalfa Sprouts Linked To Salmonella Contamination (April 26)
The U.S. Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC) today recommended that consumers not eat raw
alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further
notice because the product has been linked to Salmonella serotype Saintpaul
contamination. Other types of sprouts have not been implicated at this time.
*     *     *     * *

FDA Approves Monthly Injectable Drug for Treating Three Types of
Immune-Related Arthritis (April 24)
The U.S. Food and Drug Administration today approved Simponi (golimumab),
a monthly treatment for adults with moderate-to-severe rheumatoid arthritis,
active psoriatic arthritis, and active ankylosing spondylitis. All three conditions
are chronic disorders in which the immune system attacks multiple joints,
causing stiffness, pain, and restricted motion.

Updated FDA Action on Plan B (levonorgestrel) Tablets (April 22) On
March 23, 2009, a federal court issued an order directing the FDA, within 30
days, to permit the Plan B drug sponsor to make Plan B available to women 17
and older without a prescription. The government will not appeal this decision.
In accordance with the court’s order, and consistent with the scientific findings
made in 2005 by the Center for Drug Evaluation and Research, FDA notified
the manufacturer of Plan B informing the company that it may, upon
submission and approval of an appropriate application, market Plan B without
a prescription to women 17 years of age and older.

Plan B is manufactured by Duramed Research, Inc. of Bala Cynwyd, Pa.

FDA Researchers Contribute Insights into Avian Flu Virus (April 21)
An in-depth analysis of blood from patients recovering from the H5N1 avian
influenza virus has provided important insights into how to combat the
potentially lethal virus.

The findings by U.S. Food and Drug Administration scientists and collaborators
better explain what part of the “bird flu” virus is seen by the immune system
once a person becomes infected. As one result of this research, a protein of the
bird flu virus called PB1-F2 was identified as a potentially potent target for
attack by immune systems to stop the spread of the virus.

FDA Alerts the Public to Uncle Chen and Lian How Brand Expanded Recall
(April 16)The U.S. Food and Drug Administration (FDA) is alerting the public to
the expanded, voluntary recall by Union International Food Company (Union
City, Calif.) of sauces, oils, and oil blends sold under the Uncle Chen and Lian
How brands. The expanded recall is based on the investigation into the ongoing
foodborne illness outbreak of Salmonella Rissen. It is in addition to the recall
announced last month by the company of its dry spice products.

FDA Obtains Permanent Injunction Barring Two Companies from
Manufacturing and Distributing Unapproved Drugs (April 10)
The U.S. Food and Drug Administration today announced that it had obtained a
permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster,
Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East
Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from
manufacturing and distributing any unapproved, adulterated or misbranded
drugs. Both Neilgen, which does business as Unigen Pharmaceuticals Inc.
(Unigen), and Advent are contract manufacturers and distributors of more than
25 different unapproved drug products each. The more than 50 unapproved
drug products primarily include prescription cough and cold products. The
unapproved drugs manufactured by Unigen and/or Advent include, but are not
limited to:
* RE All 12 Suspension;
* BP Allergy Junior Suspension;
* PE Tann 20 mg/CP Tann 4 mg Suspension;
* BP New Allergy DM Suspension;
* D-Tann CT Tablets;
* B-Vex D Suspension;
* Histex SR; and
* Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets.
The unapproved drugs manufactured by these companies have not undergone
the FDA's drug approval process, so their safety and effectiveness have not
been established and the FDA has not reviewed the adequacy and accuracy of
the directions for use and warnings on the labeling. Consumers in possession
of any of these products should discontinue using them and discuss FDA-
approved treatments with their health care professional. Pharmacists should
discontinue dispensing these products.

FDA Approves Coartem Tablets to Treat Malaria (April 8)
The U.S. Food and Drug Administration has approved Coartem tablets
(artemether and lumefantrine) for the treatment of acute, uncomplicated
malaria infections in adults and children weighing at least five kilograms
(approximately 11 pounds).

FDA Serves Warrant for Inspection of Westco Fruit and Nuts Inc. (April 8)
At the request of the U.S. Food and Drug Administration, U.S. Marshals today
executed an inspection warrant at Westco Fruit and Nuts Inc.
(Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did
not provide access to distribution documents and declined to recall products
after an FDA request. Regulated companies are required by law to grant FDA
entry for inspection, as well as provide access to distribution records. The FDA
does not have authority to compel companies to recall food products, such as
peanuts.

The company, which produces and distributes peanuts and peanut products,
received peanuts and peanut product from the Peanut Corporation of America
(PCA), a Georgia company that recalled products in January due to concerns of
Salmonella contamination.

FDA Clears Rapid Test for Avian Influenza A Virus in Humans (April 7) The
U.S. Food and Drug Administration today cleared for marketing a new, more
rapid test for the detection of influenza A/H5N1, a disease-causing subtype of
the avian influenza A virus that can infect humans. The test, called AVantage
A/H5N1 Flu Test, detects influenza A/H5N1 in throat or nose swabs collected
from patients who have flu-like symptoms. The test identifies in less than 40
minutes a specific protein (NS1) that indicates the presence of the influenza
A/H5N1 virus subtype. Previous tests cleared by the FDA to detect this
influenza A virus subtype can take three or four hours to produce results.

Routine Tests Uncover Listeria Contamination in Strubs Norwegian Style
Steelhead Salmon (April 7)
The U.S. Food and Drug Administration today warned consumers not to eat
Strubs Norwegian Style Sliced Smoked Steelhead Salmon in 300 gram
packages because of potential contamination with the bacterium Listeria
monocytogenes. L. monocytogenes is a foodborne pathogen that can cause
serious illness and death.

FDA Approves Generic Topamax to Prevent Seizures (April 1)
The U.S. Food and Drug Administration has approved the first generic versions
of Topamax tablets (topiramate) to prevent seizures. Topiramate tablets in
several different strengths have been approved to be marketed by the
following firms: Roxane Laboratories Inc., Par Pharmaceuticals Inc., Mylan
Pharmaceuticals Inc., Barr Laboratories Inc., TEVA Pharmaceuticals USA,
Ranbaxy Laboratories Ltd., CIPLA Ltd., Glenmark Generics Ltd., Cobalt
Laboratories, Apotex Inc., Zydus Pharmaceuticals USA, Aurobindo Pharma Ltd.,
Torrent Pharmaceuticals Ltd., Invagen Pharmaceuticals Inc., Unichem
Laboratories Ltd., Sun Pharmaceuticals Ltd. and Pliva Hrvatska.