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Alan Franciscus
Editor-in-Chief
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In This Issue:
LG Develops Next-Generation
Hepatitis-B Drug
Counterfeit Drug Concerns a Smokescreen: Officials
Stampede of Diabetes as U.S. Races to Obesity
Magnesium May Lower Diabetes Risk
Veridien Corporation (VRDE.OB) Adds Hepatitis
A, B And C Kill Claims To Its FDA Drug Listed Products
HIV No Bar to Liver Transplantation
A Comparison of Hepatitis C Treatment and Outcomes
Anemia Drug Helpful in Patients with Hepatitis
C
Health Canada Reminds Canadians Not to Use Products Containing
Kava
December 18th, 2003
LG Develops Next-Generation
Hepatitis-B Drug
by Seo Ji-eun
Recent clinical trials have shown that a new vaccine developed
by LG Life Sciences Ltd. effectively reduces the hepatitis-B
virus in patients with the disease and caused no apparent
side effects even after large dosages, according to the makers.
The pharmaceutical division of LG Group
said in a news release yesterday that it recently completed
early-stage, second-phase clinical trials of the hepatitis
B drug, labeled LB80380, in Hong Kong. The results were presented
on the same day at the annual meeting of Frontiers in Drug
Development for Viral Hepatitis in the United States.
The tests revealed that the new vaccine
is more than five times more effective, and is less toxic,
than existing treatments, the company said. Furthermore, it
effectively curbed the growth of resistant germs and prevented
the recurrence of hepatitis B after stopping medication.
LG Life Sciences started developing the
vaccine in 1998 and successfully completed first-phase clinical
tests of the drug in England in October last year. The early-stage,
second-phase tests began in July this year.
The team plans to enter late-stage, second-phase clinical
trials with chronic hepatitis B patients around the world
next year.
LG hopes to launch the next-generation
medicine in 2007 on foreign markets such as China, which is
predicted to have the largest demand.
(spring@heraldm.com)
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December 22, 2003
Counterfeit
Drug Concerns a Smokescreen: Officials
by Kim Dixon
Reuters Health
CHICAGO (Reuters) - New attempts by major
drugmakers to block distribution of counterfeit medicines
are actually ploys to prevent reimportation of cheaper medicines
into the United States, state and city officials told Reuters
on Friday.
Pfizer Inc. on Friday said it will require
hospitals, pharmacies and distributors to buy its prescription
drugs only from wholesalers authorized by the company, following
a similar move last week by Johnson & Johnson.
That will make it more difficult for Canadian
distributors to stockpile surplus medicines for later export
to the United States.
The drug makers said the tightened distribution
is designed to stop unsafe counterfeit drugs from reaching
consumers. But U.S. officials say the moves are aimed at preventing
cheap Canadian drugs from entering the U.S. distribution system.
Wisconsin Governor Jim Doyle on Friday
called for a probe of the drugmakers' tactics, accusing Pfizer,
Wyeth, Eli Lilly & Co., GlaxoSmithKline Plc and AstraZeneca
Plc of violating antitrust laws, echoing claims made by Illinois
and Minnesota.
"It's clear that the drug companies
and the Bush administration have been doing everything they
can think of to obstruct states and cities from getting lower-priced
prescription drugs from Canada," Dan Leistikow, a Doyle
spokesman, told Reuters.
"Pfizer took its action to limit supplies
to Canadian Internet wholesalers independently," Pfizer
spokesman Paul Fitzhenry told Reuters. "Our intention
in doing so is to ensure adequate supplies of medicines for
Canadians and to protect the safety of consumers."
"It's baloney," Iowa health director
Kevin Concannon told Reuters. "I'd say if anything the
Canadian system is more tightly regulated than in the United
States."
GETTING ON BANDWAGON
Springfield, Massachusetts, in July became
the first U.S. locality to begin importing Canadian drugs
for its employees and retirees.
Since that move, cities such as New York
and Boston and the states of New Hampshire, Minnesota, Illinois,
Wisconsin and Iowa have considered following suit.
"Pfizer's announcement is not about safety but about
keeping drug prices artificially high by limiting supply and
controlling the marketplace," Springfield Mayor Michael
Albano said.
"As a trade association of 90 different
competitive companies, we don't have information" on
drug prices or company strategies, said Jeff Trewhitt, spokesman
for the trade group that speaks for most big drugmakers.
A Johnson & Johnson spokesman last
week said the issue of counterfeit drugs and not Canada was
the reason for its move.
A big Canadian pharmacy group on Friday
said it won't enter into contracts with Wisconsin and other
states for discount drugs, noting that supplies of medicines
from the five large U.S. and European drug makers are in danger
of drying up amid the clampdown on Canadian distributors.
"There is no supply problem yet, but
we foresee one with the pressure coming from these five companies,
coupled with potential wide-scale ordering," said Dave
MacKay, executive director of the Canadian International Pharmacy
Association, which represents 25 Canadian concerns.
The U.S. Food and Drug Administration opposes
the importation of drugs, arguing it can't vouch for the safety
of such medicines.
The dispute is growing after a measure
to allow easier importation failed in the U.S. Congress despite
soaring costs of drugs in the United States, the only developed
country with no price controls on medicines.
Illinois late last month said it would
limit drugs it buys from the five companies in retaliation
for their Canada stance.
Pfizer's move on Friday "seems to
be aimed at protecting their profits," Abby Ottenhoff,
spokesman for Illinois Gov. Rod Blagojevich, said on Friday.
"We haven't seen a significant problem with counterfeit
drugs from Canada."
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December 23rd, 2004
Stampede
of Diabetes as U.S. Races to Obesity
by Jane E. Brody
NY Times
Studies show HIV-infected individuals have
higher rates of diabetes than in the general population. As
well, diabetes is associated with having HCV. Fat accumulation
in the belly & perhaps lipoatrophy is associated with
glucose abnormalities.
Many people seem to think they don't have
to worry about a preventable disease that does not, at the
outset at least, have serious consequences and that can be
treated.
One such disease was long called adult-onset
diabetes. There are two things wrong here: first, this disease
does indeed have very serious consequences despite the availability
of numerous drug therapies, and second, it is no longer an
ailment that occurs almost exclusively in adults.
And so the name has been changed to Type
2 diabetes to distinguish it from the far less common kind
of diabetes (Type 1) that nearly always starts in childhood
or adolescence and has a different origin. Because so many
Americans eat too much and move too little, the nation is
now in the throes of an epidemic of Type 2 diabetes that has
spilled over into the childhood years.
Diabetes is a disorder of blood sugar regulation.
In both types glucose builds up in the blood to damaging levels
and spills into the urine. You may hear people with diabetes
say they "have sugar" or "sugar disease."
Specialized cells in the pancreas produce the hormone insulin
that has the job of moving the blood glucose into cells where
it can be used for energy or stored to meet future energy
needs.
In Type 1 diabetes, a form of autoimmune
disease, these cells fail to produce adequate amounts of insulin.
But in Type 2 diabetes, although the body typically produces
enough insulin at first, body cells are resistant to its action.
As blood glucose levels rise, the pancreas is forced to work
overtime to produce even more insulin. Eventually the pancreatic
cells may wear out, causing an insufficiency of insulin that
resembles Type 1 diabetes.
A Costly Disease
Everything you eat sooner or later can be converted into glucose.
But carbohydrates (the simple sugars like the table sugar
sucrose, corn syrup, honey, etc.) and refined starches like
white bread and pastries are most rapidly converted into glucose,
causing a spike in blood sugar that demands immediate insulin
action. Eating sugary foods and other simple carbohydrates
does not cause diabetes, but once it develops it is usually
necessary to limit — but not eliminate — consumption
of such foods.
Type 2 diabetes is no longer considered
a benign disease. It can and often does result in debilitating,
life-threatening disorders. Both kinds of diabetes greatly
increase a person's risk of heart disease, stroke, kidney
failure and blindness, as well as circulatory disorders that
can result in amputations. Experts estimate that this disease
and its consequences add up to $100 billion a year in medical
costs.
Some 17 million Americans have diabetes
(more than 90 percent of them Type 2), with about a third
of these people unaware of their disorder and its potentially
serious consequences. Another 16 million, with a condition
called prediabetes, are on their way to developing it. Worldwide,
194 million people have diabetes, which seems to accompany
rising affluence.
The incidence of diabetes has been rising
in recent years, in children as well as in adults. Considering
only diagnosed cases in adults, the prevalence rose 40 percent
in the 1990's, from 4.9 percent to 6.9 percent of adults.
By 2050, unless current trends are reversed, experts predict
a further increase of 165 percent.
Even more disturbing is a new estimate
of the lifetime risk of developing diabetes among boys and
girls born in the year 2000. An analysis published in October
in The Journal of the American Medical Association
by scientists at the Centers for Disease Control and Prevention
predicts the following for those born in 2000:
• 32.8 percent of boys and 36.5 percent of girls
will develop diabetes during their lifetimes.
• Among non-Hispanic blacks, 40.2 percent of boys
and 49 percent of girls, and among Hispanics, 45.4 percent
of boys and 52.5 percent of girls face the same fate.
• Among all those in whom diabetes is diagnosed
at age 40, men will lose 11.6 years of life and 18.6 years
of quality life and women will lose 14.3 years of life and
22 years of quality life as a result of the disease.
In other words, more than one in three
whites and about two in five blacks and one in two Hispanics
are destined to develop diabetes unless some drastic changes
occur.
The reason for this frightening prospect
is all too obvious: Americans are too fat and too sedentary.
Being overweight, and especially the accumulation of fat around
the waist, can cause insulin resistance and is the primary
risk factor for Type 2 diabetes. About three-fourths of people
with Type 2 diabetes also have high blood pressure, which
further increases their risk of cardiovascular and kidney
diseases.
A family history of diabetes is common
among those with Type 2 diabetes, so if your parents or grandparents
had it, consider that a clue to your risk and take action
now to prevent it. When a former colleague of mine, seriously
obese for his entire adult life, was told he was on the verge
of developing diabetes, he finally started taking his weight
seriously and lost 100 pounds through a sensible diet and
exercise. As a result, he lived in good health to a ripe old
age.
At first diabetes may produce few or no
noticeable symptoms, which typically develop slowly over a
period of years. But the condition is readily suspected through
a routine urine or blood test and confirmed by a glucose tolerance
test. A blood test for diabetes should be done at least once
every three years for people 45 and older and starting at
30 for those considered at high risk.
Symptoms, when they become apparent, may
include excessive thirst, frequent urination, fatigue, hunger
soon after eating, blurred vision, slow healing of wounds
and numbness or tingling in the hands and feet. Women with
diabetes may experience repeated or stubborn urinary tract
or vaginal yeast infections.
Treatment and Control
Once diabetes or prediabetes is diagnosed, the first order
of treatment is weight loss, if necessary, and regular physical
exercise. Both increase insulin sensitivity. Since people
with diabetes are highly susceptible to cardiac and blood
vessel diseases, controlling consumption of artery-damaging
saturated fats and trans fats is as important as watching
the intake of sugars and refined carbohydrates.
Since dietary fiber, both soluble and insoluble,
slows the absorption of carbohydrates, people with diabetes
are encouraged to consume mostly whole grains, along with
vegetables, unsweetened fruit and low-fat protein and dairy
foods. Fiber supplements often help, too. Consult the glycemic
index of foods to learn which foods are most likely to cause
spikes in blood sugar.
In addition to diet and exercise, most
people with established Type 2 diabetes require oral medication
to help control blood sugar levels.
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Magnesium
May Lower Diabetes Risk
by Merritt McKinney
Reuters Health
NEW YORK (Reuters Health) - An apple a
day may keep the doctor away, but new research suggests that
nuts, grains, leafy green vegetables and other foods high
in magnesium may keep diabetes at bay.
In two new studies, people who consumed
the most magnesium in their diets were less likely to develop
type 2 diabetes. This type of diabetes occurs when the body
becomes resistant to the effect of the glucose-processing
hormone insulin.
Until now, very few large studies have directly examined the
long-term effects of dietary magnesium on diabetes, Dr. Simin
Liu of the Harvard Medical School and School of Public Health
in Boston told Reuters Health.
"Our studies provided some direct
evidence that greater intake of dietary magnesium may have
a long-term protective effect on lowering [diabetes] risk,"
said Liu, who was involved in both studies.
"The take-home message for the public is that a diet
rich in plant-based foods such as nuts, whole grains and vegetables
that are high in magnesium may be beneficial for [diabetes]
prevention," Liu said.
In one of the studies, researchers evaluated
the nutrition of about 85,000 female nurses and more than
42,000 male health professionals every 2 to 4 years. Women
were followed for 18 years and the men for 12 years.
In both men and women, those who consumed the most magnesium
in their diet were least likely to develop type 2 diabetes
during the study, according to a report in the January issue
of the journal Diabetes Care. This risk reduction
was still present even after researchers adjusted for factors
that could have influenced the results, including age, total
calorie consumption, family history of diabetes, physical
activity and alcohol consumption.
Body mass index (BMI), a measure of obesity
that takes into account weight and height, did have some effect,
but the link between magnesium and a lower risk of diabetes
was still statistically significant.
Most of the participants got their magnesium
from food, not vitamin supplements. Less than 5 percent took
magnesium supplements.
The second study involved more than 39,000
women who had no history of diabetes, heart disease or cancer.
The women were followed for 6 years to see if the amount of
magnesium they consumed affected the odds of developing diabetes.
Indeed, women who consumed more magnesium
in their diet were less likely to develop diabetes, the researchers
report. But the link between magnesium and diabetes risk was
seen only in women who had a BMI of 25 or higher.
Individuals with a BMI of 25 to 29.9 are considered overweight,
while those with a BMI of 30 or higher are considered obese.
The studies leave some questions unanswered,
such as why the effect of magnesium is most pronounced in
people with a higher BMI, according to Dr. Jerry L. Nadler,
of the University of Virginia Health Science System in Charlottesville.
Despite the questions, Nadler concludes
in a related editorial that "there is now sufficient
compelling evidence to justify support for a randomized prospective
clinical trial to test the effect of consuming major food
sources of magnesium, such as whole grains, nuts and green
leafy vegetables, on the development of type 2 diabetes in
a high-risk population."
SOURCE: Diabetes Care,
January 2004.
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Veridien Corporation
(VRDE.OB) Adds Hepatitis A, B And C Kill Claims To Its FDA
Drug Listed Products
ST. PETERSBURG, Fla.—(BUSINESS WIRE)—Dec.
23, 2003
Highlights:
• Independent testing confirms new Hepatitis A,
B, and C kill claims
• Veridien's FDA drug listed products to carry
Hepatitis A, B and C kill claims starting January 2004
• Hepatitis A, B, and C kill claims provide new
revenue opportunities for 2004 and beyond
Veridien Corporation (OTCBB:VRDE) announced
today that its patented formula used in its FDA drug listed
Viraguard(R) Antiseptic Hand Sprays, Hand Gels and Hand Wipes,
has been proven to kill Hepatitis A, B and C viruses. Sheldon
Fenton, CEO, said: "The Company has positioned its patented
products to substantially increase revenue opportunities in
tandem with national and multi-national distributors. The
Hepatitis kill claims should increase demand for Veridien's
Infection Control Products in multiple markets."
Veridien's Antiseptic Products are effective
tools for healthcare professionals to minimize the spread
of diseases caused by many viruses and bacteria. Alcohol based
hand rubs are recommended by the Centers For Disease Control
in their Hand Hygiene Guidelines. The active ingredient in
Veridien's patented formulation is isopropyl alcohol. In vitro
testing has proven Veridien's patented formula to kill Hepatitis
A, B, and C, HIV-1(Aids virus), Methicillin-resistant Staphylococcus
aureus (MRSA), Vancomycin-resistant Enterococcus faecalis
(VRE), Herpes Simplex-type2, Escheria coli (E.coli) strain
157, Mycobacterium bovis (BCG,TB surrogate), Pseudomonas aeruginosa,
Streptococcus Pyogenes (Strep), Salmonella choleraesius, Staphylococcus
aureus, Respiratory syncytial virus (RSV), Rotavirus (SA-11
Group A), Influenza type1 - 2, Trichophyton mentagrophytes(athlete's
foot fungus), Cytomegalovirus (CMV) and Adenovirus-Type 2.
Paul Dunnigan, VP-Marketing Group, said:
"Based on conversations with our customer base, we expect
the enhanced kill claims to positively impact our revenues
for 2004 and beyond. With the recent virulent outbreaks of
Hepatitis and Influenza across North America, Veridien's Patented
Infection Control Products should provide healthcare professionals
and consumers alike with effective tools to help prevent the
spread of illness in the workplace and at home."
Veridien's Infection Control Products are available to healthcare
professionals through major medical distributors, and to consumers
at http://www.buyveridien.com. Effective January 2004, Viraguard(R)
Antiseptic Infection Control Products will carry the Hepatitis
A, B and C kill claims.
About Veridien
Veridien Corporation is a Health Care Company
focusing on Infection Control and other Healthy Lifestyle
products. Veridien has developed PATENTED and UNIQUE PRODUCTS
including SURFACE DISINFECTANTS, ANTISEPTIC HAND CLEANSERS,
INSTRUMENT PRESOAK, AND SUN PROTECTANT PRODUCTS. The flagship
product Viraguard(R) Hospital Disinfectant/Cleaner and Instrument
Presoak is a skin friendly, patented, U.S. - EPA and Health
Canada registered, surface disinfectant. Viraguard(R) Hospital
Surface Disinfectant Towelettes and Viraguard (R) Toilet Seat
Wipes (Sit Secure (TM) program) are also U.S.- EPA registered.
Viraguard(R) Antiseptic Hand Gel, Viraguard(R) Antiseptic
Hand Spray and Viraguard(R) Antiseptic Hand Wipes are all
U.S. - FDA and Health Canada drug listed products utilizing
Veridien's patented Virahol(R) formulation.
Look for Veridien at
http://www.veridien.com
Special Note: Forward-looking statements
in this press release are made pursuant to the "safe-harbor"
provisions of the Private Securities Litigation Reform Act
of 1995. Investors are cautioned that such forward-looking
statement involve risks and uncertainties, including without
limitation, market acceptance of, and demand for, the Company's
products, manufacturing, development and distributor issues,
product pricing, competition, funding availability, technological
changes and other risks not identified herein. The Company
disclaims any intent or obligation to update any forward-looking
statements. "HEALTHY LIVING IS AN ADVENTURE - LET VERIDIEN
GUIDE YOU"
Contacts
Veridien Corporation, St. Petersburg Cheryl Ballou, 727/576-1600
ext 202 cballou@veridien.com
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December 24th, 2003
HIV No Bar
to Liver Transplantation
by David Douglas
Gastrohep.com
Dec 2003 - HIV infection should no longer
be considered a contraindication to liver transplantation,
researchers from the US and UK report in the November 15th
issue of the Journal of Infectious Diseases.
As lead investigator Dr. Margaret V. Ragni
told Reuters Health, "this multicenter collaborative
study demonstrated that survival in HIV-positive transplant
recipients is similar to that found in age- and race-matched
HIV-negative recipients."
Dr. Ragni of the University of Pittsburgh
and colleagues hypothesized that the immune function restoration
and improved survival made possible by highly active antiretroviral
therapy might lead to such an outcome.
To investigate, the researchers followed 24 HIV-positive subjects
with end-stage liver disease who were undergoing orthotopic
liver transplantation.
Post-transplant survival was not significantly
different in this group than it was in a cohort of HIV-negative
subjects.
At 12 months, in the HIV-positive group,
survival was 87.1%, and at 24 and 36 months it was 72.8%.
Corresponding proportions in HIV-negative patients were 86.6%,
81.6% and 77.9%.
Survival was poorer in HIV patients with post-transplant antiretroviral
intolerance, a CD4+ cell count of less than 200 cells per
microliter, an HIV load of more than 400 copies per mL and
hepatitis C infection.
Overall, Dr. Ragni added, these findings
should "provide new hope for many HIV-infected patients
who might otherwise die of end stage liver disease."
J Infect Dis 2003;188:1412-1420.
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A
Comparison of Hepatitis C Treatment and Outcomes
reutershealth.com
Researchers in the January issue of Alimentary
Pharmacology and Therapeutics find that there are significant
differences in both treatment practice and use of diagnostic
procedures in patients with hepatitis C.
There is a lack of published data examining
hepatitis C treatment practices in different care settings.
In this study, researchers from the United
States described treatment practices for patients with hepatitis
C virus infection in clinical practice. They also examined
the clinical outcomes in patients treated with interferon
alpha-2b/ribavirin combination therapy in academic, private,
and Veterans' Affairs treatment centers.
The team retrospectively evaluated hepatitis
C virus treatment practices in 231 patients receiving interferon
alpha-2b, between 1997 and 2001.
The researchers identified differences
in both treatment practice and use of diagnostic procedures.
They found that genotype testing was under-utilized
in non-academic centers.
However, liver biopsies were performed
less often in private centers.
The team determined that end-of-treatment
viral response was lower than that found in published trial
data.
Multivariate analysis revealed genotype
1 as the single significant predictor of treatment failure.
Dr Jensen's team concluded, "Outside of the academic
setting, there is significantly less diagnostic work-up performed
prior to the initiation of hepatitis C virus therapy".
"This suggests a need for a standardization
of care across treatment settings".
Aliment Pharmacol Ther 2004; 19(1):
69-77
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Anemia
Drug Helpful in Patients with Hepatitis C
Reuters Health
NEW YORK (Reuters Health) - The red blood
cell-boosting drug erythropoietin improves hemoglobin levels
in patients with anemia caused by the drugs used to treat
hepatitis C.
The hepatitis C virus can cause permanent
liver damage, cancer, or even death. Early symptoms include
fatigue, which can progress to the yellow staining of the
skin called jaundice and swelling of the abdomen. People can
get the virus through any exposure to infected blood, including
intravenous drug use, body piercing, tattooing, unbandaged
cuts or poorly sterilized medical equipment and blood transfusions.
Standard treatment for hepatitis C infection
includes the immune system protein interferon alfa in combination
with the antiviral agent ribavirin, both of which are associated
with decreased hemoglobin levels, Dr. Douglas T. Dieterich
and his associates note in The American Journal of Gastroenterology.
When anemia results, ribavirin doses are usually reduced to
levels that are likely to be less effective in controlling
the hepatitis C virus.
Dieterich, from Mount Sinai School of Medicine,
New York, and colleagues evaluated the efficacy of once-weekly
doses of epoetin alfa in alleviating anemia and minimizing
ribavirin dose reductions in 64 anemic, HCV-infected patients.
After 16 weeks, patients assigned to epoetin
alfa treatment had higher mean hemoglobin levels than did
patients assigned to standard care, the authors report.
Moreover, 83 percent of patients receiving
epoetin alfa maintained daily ribavirin doses of 800 mg or
more, compared with only 54 percent of patients receiving
standard care.
Improvements in quality of life measures
were greater in the epoetin alfa treatment group than in the
standard care group, the investigators report, and epoetin
alfa treatment was well tolerated.
"Based on the results of this study,"
the authors conclude, "epoetin alfa seems to be promising
for the treatment of anemia in HCV-infected patients receiving
ribavirin/interferon combination therapy. Further research
is warranted to investigate the potential impact of epoetin
alfa therapy on outcomes, including quality of life and sustained
viral response."
SOURCE: American Journal
of Gastroenterology, November 2003.
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Health
Canada Reminds Canadians Not to Use Products Containing Kava
Canadian Press, www.canada.com
OTTAWA (CP) - Health Canada is again warning
consumers of the serious risks associated with the use of
products containing kava.
There have been reports associating kava
with serious liver dysfunction and Health Canada issued a
stop-sale order in August 2002 for all products containing
kava. The department also requested that all kava products
be recalled and advised consumers not to use these products.
However, an independent market survey showed
that many retail outlets are still selling products containing
kava. So Health Canada has issued another letter to industry,
pharmacists and retail outlets, to remind them of the recall
and stop sale order.
There have been four cases of liver toxicity
associated with the use of kava products reported in Canada
although none of the cases resulted in death. Other foreign
regulatory authorities have also received reports of liver
toxicity associated with the use of kava, among which there
were three fatalities.
People who have compromised liver function
due to pre-existing liver problems may be at particular risk
of liver toxicity associated with kava. It has also been associated
with side effects that include an itchy, scaly skin condition,
known as kava dermopathy; muscle weakness, and co-ordination
problems.
Kava is found in a range of herbal and
homeopathic preparations and may also be occasionally found
in food. It is reportedly used for anxiety, nervousness, insomnia,
pain and muscle tension.
Consumers who find kava products
on the shelves should report their findings to the Health
Products and Food Branch Inspectorate by calling, toll-free,
1-800-267-9675.
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