Other waters might think we're crazy, and we are. But that's just because they're jealous that
they can't add naturally occurring minerals to their water, only synthetic ones (yuck!) And thanks to our high level of natural
minerals, which are more readily absorbed by your body than synthetic minerals, Crazy Water can't be beat.
not just water: we're also a natural sports drink (without all those scary artificial flavors and sugars) which helps aide
in rehydration and recovery. How's that for a bottle of water?
The Benefits Of Our Crazy Minerals
Alkalinity – At
- Neutralizes acid in the human body
- Provides free oxygen to tissue
- Essential for vitality and a healthy life
Sodium Bicarbonate – NaHCO3C
Helps delay the onset of fatigue
Helps in maintaining the body’s pH balance
Assists in neutralizing lactic acid generated by physical activity
Calcium – Ca++
Chloride – CI-
Fluoride – F-
Magnesium – Mg++
Found in almost all human cells
Helps strengthen bone structure
Helps expand blood vessels
Manganese – Mn
Helps in preserving bone density
Helps breaks down fats, carbohydrates and proteins
Aides in stabilizing free radicals, which may damage the body
Potassium – K+
Silica – SiO2
Essential mineral building block and one of the body’s greatest energizing nutrients
Helps tissue repair by serving as an antioxidant
Strengthens hair and nails
Sulfate – SO4
Zinc – Zn
Strengthens the immune system and improves white blood count
Aides the body’s absorption of minerals
Improves the health of skin and hair
August 27, 2010-Due to the unsecured and improperly sealed
caps, Schering-Plough Healthcare Products, Inc. quietly released a product recall last Thursday of the OTC laxative Miralax.
Miralax-polyethylene glycol 3350 for treatment of
The recalled products include Miralax Laxative Power (30-day
dose,17.9 oz.) UPC (bar code) of Miralax Laxative Powder and 4110082071 (30 days dose, 19.9 oz.) 4110080770.Miralax with UPC
is a laxative medicine powder, sold in pharmacies without a prescription from a doctor. First, laxatives which occasionally
blocked and not extended or daily use. Miralax works by causing water retention in the body and thus makes a slight movement
of the bowl.In
Besides the Miralax, S chering-Plough manufactures the Clarinex and Claritin allergy popular. The pharmaceutical
company also has products for Dr Scholl and Coppertone. In 2009 they teamed up with Merck. Schering-Plough indicates that
the recall only side effects and said there were no reports of consumer injury.The company also asserts, "Miralax is safe
and effective – without prescription. This is the first prescription laxative in more than 30 years, be available over
the counter (OTC).
Recall of Schering-Plough includes 30 days supply versions Miralax. One of them, 17.9 oz bottle,
while another 19.9 grams of 4 count bag included. Same version of the drug caps, which may be incorrectly installed on the
bottle, making a possible external contamination or strangulation for young children. If the bottle has a bad hat, treatment
should be destroyed. Consumers can also contact their customer service representatives and ask questions about the recall.
FDA: Possible Fracture Risk with High Dose, Long-term Use of Proton Pump Inhibitors
May 25, 2010-The U.S. Food and Drug Administration today warned consumers and health care professionals
about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications
called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.
Proton pump inhibitors, available by prescription and over-the-counter (OTC), work by reducing the amount
of acid in the stomach. Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole
(Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). Prescription proton pump
inhibitors are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers,
and inflammation of the esophagus.
OTC versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC)
and lansoprazole (Prevacid 24HR).
“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton pump
inhibitors for one year or longer, or at high doses,” said Joyce Korvick, M.D., deputy director for safety in FDA’s
Division of Gastroenterology Products. “Because these products are used by a great number of people, it’s important
for the public to be aware of this possible increased risk and, when prescribing proton pump inhibitors, health care professionals
should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.”
FDA’s warning and decision to revise the labeling of proton pump inhibitors are based on the Agency’s
review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist and spine in patients
using proton pump inhibitors. Both the Warnings and Precautions section of the prescription labeling and the Drug Facts label
on OTC proton pump inhibitors will address these findings.
Health care professionals and consumers should weigh the known benefits against the potential risks of proton
pump inhibitors when determining if these medications are appropriate for treatment. Consumers also should talk with their
health care professional about any concerns.
Any side effects or other product problems with proton pump inhibitors should be reported to FDA’s MedWatch
Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
IMPORTANT UPDATE REGARDING SLIM•FAST®
RTD SHAKES IN A CAN
January 20, 2010-Thank you for your continued patience,
support and loyalty through the Slim•Fast ready-to-drink (RTD) shakes in a can recall, which we announced on December
3, 2009. This was a very difficult decision for us to take, but was unquestionably the right one, as consumer safety is and
always must be our top priority.
We're pleased to inform you that you may begin
to see Slim•Fast RTD shakes in a can in stores later this month. As detailed below, all newly produced Slim•Fast
RTD shakes in a can will be clearly marked to help you identify new RTD product from recalled RTD product.
Individual Slim•Fast RTD shakes in a can: Manufacturing code information on bottom of cans
is now in blue ink instead of black
RTD shake club packs: 3” x 3” round, gold metallic sticker on the side of club pack trays, which
reads “Quality is our #1 priority”
Slim•Fast RTD shake multi-pack cartons: 2” x 2” round, gold
metallic sticker on top of cartons, which reads “Quality is our #1 priority” (see below image)
Recall Unilever conducts Nationwide Voluntary Recall of Slim-Fast Ready-to-Drink Prodcuts in Cans Due to Possible Health Risk
December 3, 2009-Unilever Conducts Nationwide Voluntary Recall of Slim-Fast® Ready-to-Drink Products in Cans Due to
Possible Health Risk.
Unilever United States, Inc., in cooperation with the U.S. Food and Drug Administration
(FDA), is conducting a nationwide voluntary recall of all Slim-Fast® ready-to-drink (RTD) products in cans, due to the possibility
of contamination with Bacillus cereus, a micro-organism, which may cause diarrhea and possibly nausea and/or vomiting. The
probability of serious adverse health consequences is remote.
The products were sold in stores nationwide.
The products are packaged in paperboard cartons and contain four, six or 12
steel cans that are 11 FL OZ (325 mL) each. Individual cans are also sold in certain retail outlets. The recall involves all
Slim-Fast® RTD products in cans, regardless of flavor, Best-By date, lot code or UPC number. A listing of all RTD recalled
products is attached to this press release.
No other Slim-Fast® products are affected by this recall. No Slim-Fast® powdered
shakes, meal bars, or snack bars are affected by this recall.
The recall was initiated after the company conducted quality testing on Slim-Fast®
RTD products in cans. Out of an abundance of caution, the company is recalling all RTD products in cans that are currently
in distribution centers, on-shelf or in back rooms in retail outlets or in consumers’ homes. The company is in the process
of identifying and correcting the production issue, and will resume production and shipment of the product when the issue
has been addressed and corrected.
Consumers who have purchased Slim-Fast® RTD products in cans are urged to
discard them immediately and contact the company at 1-800-896-9479 for a full refund. The Consumer Services Center is open
Monday – Friday, 8:30 AM – 6:00 PM ET. A recorded message is available 24/7.
September 21, 2009-FDA Requires Boxed Warning
for Promethazine Hydrochloride Injection
The U.S. Food and Drug Administration
is telling manufacturers of the drug
promethazine to include a boxed warning regarding the injectable form of the
The warning, under FDA's authority to require safety labeling changes,
will highlight the risk of serious tissue injury
when this drug is administered
incorrectly. The agency is also alerting health care professionals to the new
for this product, which is used as a sedative and to treat nausea
Promethazine should neither be administered
into an artery nor administered
under the skin because of the risk of severe tissue injury, including gangrene,
boxed warning says. There is also a risk that the drug can leach out from
the vein during intravenous administration and
cause serious damage to the
surrounding tissue. As a result of these risks, the preferred route of
injecting the drug deep into the muscle.
A requested revision in the Dosage and Administration section of the label
that if health care professionals choose to administer promethazine
intravenously, they should limit the drug's concentration
and rate of
administration and ensure a properly functioning intravenous line.
The companies that make promethazine
are required to submit the requested safety
label changes to the FDA within 30 days or provide a reason why they do not
such changes are necessary. If they do not submit new language, or the
FDA disagrees with the language proposed by the
companies, the agency can order
the label change as deemed appropriate to address the new safety information.
was previously sold under the brand name Phenergan, but that
formulation was discontinued by Wyeth Pharmaceuticals Inc.
A number of
companies currently market generic formulations of promethazine hydrochloride
previously informed consumers and health care professionals about the
risks of incorrect administration of promethazine
in the December 2006 and
February 2008 editions of FDA Patient Safety News. Current prescribing
information for the
drug contains information about the risk of tissue injury,
possibly including gangrene, if the drug is inadvertently administered
artery, but that information was not highlighted in a boxed warning.
Promethazine first went on the market
in 1956. FDA has reviewed the published
literature and post-marketing adverse event reports submitted to the agency's
Event Reporting System from 1969 to 2009 and identified cases of
gangrene requiring amputation associated with administration
of the drug.
FDA Gives Update on Botulinum Toxin Safety Warnings;
Established Names of Drugs Changed
August 3, 2009-The U.S. Food and Drug Administration today announced
an update to a previous safety alert on four botulinum toxin drug products, noting that all of them now have boxed warnings
on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009.
The boxed warning cautions that the effects of the botulinum
toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those
symptoms include potentially life-threatening swallowing and breathing difficulties and even death.
These symptoms have mostly been reported in children with cerebral
palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms
have also been reported in adults treated both for approved and unapproved uses.
The affected products are:
- Botox (new established name:
- Botox Cosmetic (new established name: onabotulinumtoxinA)
- Myobloc (new established name: rimabotulinumtoxinB)
Dysport (abobotulinumtoxinA) was approved in April 2009 with the boxed warning and is not making any name or label changes
at this time.
No definitive serious adverse event reports of distant spread
of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses (for frown lines
between the eyebrows or severe underarm sweating). As well, no definitive serious adverse event reports of distant spread
of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or for crossed eyes.
The revised labels also emphasize that the different botulinum
toxin products are not interchangeable, because the units used to measure the products are different. To help reduce the potential
for dosing errors, the botulinum toxin products have changed their established drug names (often referred to as the drug’s
“generic” name). Neither the brand names nor the formulations of the products have changed.
'FDA SLAPS WARNING ON HEARTBURN DRUG REGLAN TIED
February 26, 2009: WASHINGTON – Federal
health officials are adding their sternest warning to a heartburn drug that has been linked to muscle spasms.
The Food and Drug Administration
said the drug, widely known as Reglan, has been shown to cause spasms and tics when used for long periods of time or at high
doses. The problems include uncontrollable movement of the limbs, face and tongue, and are usually irreversible, even after
patients stop taking the drug, according to the FDA's warning.
The agency is requiring drugmakers to add a black
box warning, the most serious type available, to their products.
Manufacturers also will be required to distribute
medication safety guides to patients.
The drug was marketed by Wyeth for a number of
years. However, the Madison, N.J.-based company sold the tablet form to Schwarz
Pharma in 2001 and the injectable form to Baxter International in 2002. The drug also is marketed by a number of generic
The drug's current labeling already mentions risks
of developing the spasms, called dyskinesia, but the agency's action Thursday elevates the warning to the top of the label.
Reglan, known generically as metoclopramide, comes in a variety forms, including injections and edible syrups. The drug works
by speeding up the muscles used in digestion and relieving painful stomach acid
More than 2 million U.S. patients use the drugs,
according to the FDA.
"The chronic use of metoclopramide therapy should
be avoided in all but rare vases where the benefit is believed to outweigh the risk," said Dr. Janet Woodcock, director of
FDA's drug center.
Regulators said patients who face the greatest
risks include the elderly, especially women, and those who have been taking the drug for more than three months.
The agency based its decision on recently published
studies suggesting metoclopramide is the leading cause of pharmaceutical-related movement
disorders. One study showed that roughly 20 percent of patients who take the drug longer than three months develop
Prucalopride Relieves Constipation with No Signs of Heart Risk
|By Charles Bankhead, Staff Writer,
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School,
Minn., May 28 -- Patients with severe, chronic constipation had a two- to three-fold improvement in bowel movements with the
selective 5-HT4 receptor agonist prucalopride (Resolor) versus placebo, investigators here reported.
a 12-week trial, bowel function improved significantly with prucalopride, whether defined by total number of bowel movements
or the percentage of patients with three or more movements weekly, Michael Camilleri, M.D., of the Mayo Clinic, and colleagues
reported in the May 29 issue of the New England Journal of Medicine.
The agent's stimulation of three or more
bowel movements in significantly more patients "reflects the normalization of bowel function," the authors said. Moreover,
the improved bowel function was associated with a 50% decrease in the need for rescue medication.
- Explain to patients that an investigational drug
for chronic constipation significantly improved bowel function in a randomized clinical trial.
- Note that the drug is not yet available and that
the findings require confirmation in additional studies.
satisfaction with bowel function and treatment and their perception of constipation severity also improved with both doses
of prucalopride evaluated in the study. Additionally, the treatment caused no significant cardiovascular effects.
Concern about cardiovascular effects led to the demise of two earlier 5-HT4 receptor agonists. Tegaserod
was withdrawn from the U.S. market after evidence of ischemic events, and cisapride was pulled because of conduction abnormalities
leading to a prolonged QT interval.
of those two agents left lubiprostone (Amitiza) as the only prescription drug approved in the U.S. for treatment of chronic
constipation and constipation-predominant irritable bowel syndrome.
cisapride, and several other 5-HT4 receptor agonists are nonselective and exert effects on other types of 5-HT
receptors and on the ether-a-go-go related (hERG) protein channel. The lack of specificity for 5-HT4 receptors
may lead to an unfavorable cardiovascular profile, said Dr. Camilleri and colleagues. In contrast, prucalopride is highly
selective for the 5-HT subtype 4 receptor.
improves colonic motility and transit. In phase II trials, the drug significantly increased the frequency of bowel movement
and patient satisfaction with bowel function.
investigation of prucalopride continued in a phase III trial involving 620 patients with a history of chronic constipation,
defined as two or fewer spontaneous, complete bowel movements weekly for at least six months. Additionally, patients had to
pass hard or very hard stools, have a sensation of incomplete evacuation, or straining during defecation during at least 25%
of bowel movements.
were randomized to placebo or to 2 or 4 mg of prucalopride daily for 12 weeks. The primary efficacy endpoint was the proportion
of patients having three or more spontaneous, complete bowel movements weekly, averaged over the 12 weeks of the trial.
end of the study, 30.9% of patients treated with 2 mg of prucalopride had three or more bowel movements weekly, as did 28.4%
of the 4-mg prucalopride group, versus 12% in the placebo group (P<0.001). Additionally, 47.3% of the 2-mg group
and 46.6% of the 4-mg group had an increase of at least one bowel movement weekly, averaged over the 12 weeks of the study
patient-assessed symptom score decreased significantly with prucalopride versus placebo, as did the stool and abdominal symptom
subscore (P=0.008 to P<0.001). Patients on active treatment reported significant improvement in quality
of life (P<0.001 versus placebo) and significant reductions in the need for rescue medication for constipation
(P<0.001 versus placebo).
common treatment-related adverse events were headache and abdominal pain.
encouraging, the results do not establish the cardiovascular safety of prucalopride, particularly given the relatively small
number of patients who continued treatment for the entire 12 weeks of the study (85% of total), University of Rochester (N.Y.)
cardiologist Arthur J. Moss, M.D., wrote in an accompanying editorial.
also expressed concern about the nine-year lag between the study's design and completion. Moreover, the reasons for temporary
suspension of the trial in 2001 are unclear, he added.
"It is not clear . . . why it took so long to bring this study to publication," said Dr. Moss.
Viagra-GP Possible Connection for Cure?
Viagra (sildenafil), which is marketed for male
dysfunction, but has also shown some benefit.
Researchers at Johns Hopkins University found that part of the delay in stomach emptying occurs as a result of lack of nitric
oxide in stomach tissues. The same basic molecular problem causes impotence in men. Experiments have shown that in mice Viagra
reversed gastroparesis. Human trials are underway.
February 8, 2008 WASHINGTON (AP)
A public interest group petitioned the Food and
on Thursday to increase the warnings on the
popular cosmetic and drug Botox.
Dr. Sidney Wolfe of Public Citizen Health
Research Group said severe
reactions including deaths have been linked to the product.
Botox and another drug, Myobloc,
use botulinum toxin, which blocks
nerve impulses to muscles, causing them to relax.
But in a few cases, the toxin
has spread to other parts of the body,
resulting in problems including paralysis of respiratory muscles and
swallowing, potentially leading to food or liquids
entering the lungs and causing aspiration pneumonia, Wolfe said.
Citizen sought so-called black box warnings on both products.
Pedialyte Proves to be Top Product
for Dehydration-Great News for all Gastroparesis Patients!
Athletes and many alike have both discovered
the life-giving properties of drinks meant to starve off dehydration in sick babies, one of the top-'Pedialyte'.
Infant rehydration solutions such as Pedialyte
are the latest craze in locker rooms, replacing drinks such as Gatorade. Pedialyte products are flavored solutions of water,
glucose, sodium and potassium. They are designed to replace water and electrolytes lost by infants through diarrhea or vomiting
but now are becoming the top product for dehydration as well in adults.
The product solutions contain more sodium and
potassium than most sports drinks, such as Gatorade, said Susan Bowerman, a sports dietician and assistant director
of the Center for Human Nutrition at the University of California-Los Angeles.
* I have used Pedialyte as a GP
patient for many years and stand by this product in aid of dehydration-Give it a try and you will agree!
Proctor & Gamble Releases New Probiotic-"ALIGN" on the Market!
There is a new product out on the market from Proctor & Gamble
called "ALIGN"-GI Daily Probiotic Suppliment.
Align aims towards those who suffer from IBS thus using *Bifantis-Bifantis
is the trademarked name for the probiotic strain Bifidobacterium infantis 35624. Clinical trials have demonstrated that regular
use of this probiotic strain promotes normal digestive health, even for people who suffer from Irritable Bowel Syndrome Bifantis
deliver millions of good bacteria to work within the digestive (IBS). These normal, friendly bacteria play an important role
in basic digestion, proper metabolism and overall well-being. Capsules of system to restore intestinal balance and maintain
normal digestive health.
*(Bifantis is not a drug; it's a natural supplement that is similar
to the active cultures found in some yogurts and fermented milks).
Align is a daily dietary supplement that works naturally to help build
and maintain a healthy, balanced digestive system. Align is an easy-to-swallow capsule that you take just once a day, every
day to help even out the ups and downs of common digestive upsets such as constipation, diarrhea, abdominal discomfort, urgency,
gas, and bloating. Align capsules contain Bifantis, a unique probiotic strain that has been clinically proven to build and maintain a
strong, healthy digestive system.
People who occasionally suffer from one or more of the following common
digestive upsets would benefit from taking Align:
- Abdominal discomfort
- Gas and bloating
New product to hit the market from the makers of 'VitaWater'-Glaceau
company. This is one of the best new drinks for all GP'ers as well those who are physically active to help stay hydrated and
keep those electrolytes in balance which lack of leads to dehydration and unwanted medical bills. Indeed worth looking into
at your local stores!
July 11, 2006: 4:00 p.m. EST
and FREMONT, Calif., July 11 (PRNewswire) -
CINCINNATI and FREMONT, Calif., July 11, 2006 /PRNewswire/ --
& Gamble Pharmaceuticals, Inc., a division of The Procter &
Gamble Company and ARYx Therapeutics, a private drug
development company, today announced a strategic alliance under
which P&G will develop and commercialize
ARYx's novel drug, ATI-
7505, for the treatment of gastrointestinal disorders such as
gastroesophageal reflux disease
(GERD) and gastroparesis (delayed
emptying of the stomach).
Severe idiopathic gastroparesis due to neuronal
and interstitial cells of Cajal degeneration: pathological findings and management.
1 Digestive System Research Unit, Hospital
General Vall d’Hebron, Barcelona, Spain
2 Intestinal Disease Research Program, McMaster University, Hamilton,
Delayed gastric emptying
can be due to muscular, neural, or humoral abnormalities. In the absence of an identified cause, gastroparesis
is labelled as idiopathic. We present the case of a patient with severe idiopathic gastroparesis. Pharmacological
approaches failed, as well as reduction in gastric emptying resistance with pyloric injection of botulinum
toxin and pyloroplasty. Therefore, subtotal gastrectomy was performed. Histological and immunohistochemical
study of the resected specimen showed hypoganglionosis, neuronal dysplasia, and a marked reduction in
both myenteric and intramuscular interstitial cells of Cajal. To our knowledge, this is the first time these rare
histological findings have been described in a patient with idiopathic gastroparesis. http://gut.bmj.com/cgi/content/abstract/52/7/966
Scientists build world's first artificial
High-tech box simulates human
digestion — it even vomits
Lefteris Pitarakis / AP
have built what they say is the world's first artificial gut: a shiny, high-tech box that physically simulates human digestion.
Updated: 2:45 p.m. ET Nov 10, 2006
- British scientists have built what they say is the world's first artificial stomach: a shiny, high-tech box that physically
simulates human digestion.
Constructed from sophisticated plastics and
metals able to withstand the corrosive acids and enzymes found in the human gut, the device may ultimately help in the development
of super-nutrients, such as obesity-fighting foods that could fool the stomach into thinking it is full.
"There have been lots of jam-jar models of digestion
before," said Dr. Martin Wickham of Norwich's Institute of Food Research, the artificial gut's chief designer, referring to
the beakers of enzymes typically used to approximate the chemical reactions in the stomach.
By understanding how food gets
processed in the gut, and in which part of the stomach nutrients get absorbed, researchers may be able to develop foods designed
to manipulate the digestive process, a strategy that would have broad implications for public health.
For instance, knowing how quickly glucose gets
absorbed into the bloodstream could potentially help treat diabetes.
"Our knowledge of what actually happens in the
gut is still very rudimentary," said Wickham, "but we hope that this model can help fill in some of the blanks."
Some experts say any artificial gut has inherent
"The stomach is an extraordinarily complex organ,
so you cannot create a model that will undertake all of these functions," said Dr. Stephen Bloom, head of metabolic medicine
at Imperial College in London, who was not involved in the project.
Still, Bloom said that looking at issues such
as the breakdown of food and the role of enzymes in a model stomach is valuable.
So real it can even vomit
With a capacity
about half the size of an actual stomach, the artificial gut can "eat" roughly 24 ounces of food. To date, the most substantial
meal it's enjoyed is vegetable soup.
"It's so realistic that it can even vomit,"
The model gut, which was funded by the British
government, was built at a cost of approximately $1.8 million. Wickham and his colleagues are currently negotiating with about
a dozen companies regarding future projects for the gut.
*Spreading GP Awareness One Person At A
You My Friend Will Never Again Walk Alone.