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SEROVERA® Blog

Natural MarketPlace 2010

Posted on June 15, 2010 by SEROVERA

The Natural Products Association represents more than 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids.

SEROVERA® was present in the Las Vegas TradeShow to make sure our products comply with the latest Good Manufacturing Practices (GMP) and FDA regulations.

The Natural Products Association, the largest dietary supplement trade association in the United States, has developed GMP standards based upon dialogs with member suppliers, other trade associations, and the FDA.

The Natural Products Association GMPs are a living document and will be updated periodically based upon feedback from consultants, member companies, best quality practices and the FDA.

Mrs C.Perrin / Vice-President, Mrs N.Williams/Customer Account Representative, and Mrs S. Silkman/Director-Key Accounts (top photo)

Posted in General | Comments Off

FDA Good Manufacturing Practices

Posted on June 9, 2010 by SEROVERA


SEROVERA® at the forefront of FDA Good Manufacturing Practices (GMP)

SEROVERA® has always taken a leadership role in promoting FDA quality standards and has developed internal self-regulatory programs for that purpose.

To that end, executives at SEROVERA® will be attending an Advanced Course on the Final FDA GMP Rule for Dietary Supplements at the 2010 Natural MarketPlace, to help further strengthen our stringent requirements for manufacturing, packaging, labeling, and holding of dietary supplements.

The seminar agenda will include:

-Overview of FDA GMPs

-Comprehensive discussion of specific FDA GMP requirements including stablishing and confirming specifications, QC personnel responsibilities, laboratory operations, scientifically valid analytical methods, raw materials and finished product testing requirements, and change control

-Developing GMP-compliant SOPs, master manufacturing and batch production records, and other required documentation

-Qualifying your suppliers and other vendors to ensure quality and consistency in meeting GMP compliance (a hot topic with FDA!)

-Qualifying certificates of analysis to allow for reduced testing of components

-Third-party certification

-How to handle visits from the FDA and discussion of FDA expectations based on recent FDA GMP inspections

-Tips on getting started incorporating new FDA GMP requirements within your company’s current GMP systems

-Opportunity for technical question and answer discussion with industry GMP experts

-Group activities regarding establishing regulatory specifications and developing adequate procedures

Posted in fda, SEROVERA | Comments Off

Possible link between C-sections and celiac disease

Posted on June 3, 2010 by SEROVERA

Researchers in Germany have found a possible link between celiac disease and Cesarean sections.

Celiac disease is a disorder where eating gluten, a type of protein found in wheat, barley and rye, causes the body’s immune system to attack and damage the small intestine.

Researchers in Germany studied children and adolescents with intestinal problems, including Crohn’s disease, ulcerative colitis and celiac disease. They found that 28 percent of the celiac children were born by Cesarean section, compared to no more than 19 percent of all other groups.

Doctors say many of the children’s mothers may have had undiagnosed celiac disease, which can increase the risk of cesarean section.

The study is published online in the journal Pediatrics.

This article is a reprint of http://abclocal.go.com/wls/story?section=news/health&id=7447994
The time or date displayed reflects when an article was added to Google News May 18. 2010

Posted in Celiac Disease, Crohn's Disease | Comments Off

Bowel disorders lead to poor bone health, study finds

Posted on May 14, 2010 by SEROVERA

Women with inflammatory bowel disorders may want to consider further lab testing to see if they are also positive for osteoporosis, as a new study suggests that individuals with Crohn’s disease and ulcerative colitis are also more likely to suffer bone breaks.

Researchers found that these common bowel diseases increase a person’s risk for breaking a bone, because the disorders make it more difficult for their body to absorb nutrients like protein, calcium and vitamin D that are the key to bone health.

Individuals with these diseases are also at a disadvantage because many of the common drugs used to treat the condition block the body from making the best use of nutrients.

Deficiencies of these nutrients in women can also increase their risk of developing osteoporosis as they age.

Researchers suggested that doctors who are treating individuals with these bowel disorders should also test them for bone health, and start them on treatments to increase the level of these nutrients in their body.

Posted in Bowel disorders, Crohn's Disease, ulcerative colitis | Comments Off

Aspirin raises Crohn’s disease risk

Posted on May 4, 2010 by SEROVERA

People who take aspirin regularly for a year or more could be increasing their risk of developing Crohn’s disease, says a new study.

The study by University of East Anglia (UEA) will be presented for the first time at the Digestive Disease Week conference in New Orleans.

Crohn’s disease is characterized by inflammation and swelling of any part of the digestive system. This can lead to debilitating symptoms and requires patients to take life-long medication. Some patients need surgery and some sufferers have an increased risk of bowel cancer.

Though there are likely to be many causes of the disease, previous work on tissue samples has shown that aspirin can have a harmful effect on the bowel.

Though there are likely to be many causes of the disease, previous work on tissue samples has shown that aspirin can have a harmful effect on the bowel.

The volunteers were all initially well, but by 2004 a small number had developed Crohn’s disease. When looking for differences in aspirin use between those who did and did not develop the disease, the researchers discovered that those taking aspirin regularly for a year or more were around five times more likely to develop Crohn’s disease.

The study also showed that aspirin use had no effect on the risk of developing ulcerative colitis – a condition similar to Crohn’s disease.

“This is early work but our findings do suggest that the regular use of aspirin could be one of many factors which influences the development of this distressing disease in some patients,” said lead researcher Dr Andrew Hart of UEA’s School of Medicine.

“Aspirin does have many beneficial effects, however, including helping to prevent heart attacks and strokes. I would urge aspirin users to continue taking this medication since the risk of aspirin users possibly developing Crohn’s disease remains very low – only one in every 2000 users, and the link is not yet finally proved.”

Posted in aspirin, colitis, Crohn's, Crohn's Disease | Comments Off

Which treatment is effective in maintaining remission in ulcerative colitis: Probiotic or placebo?

Posted on April 20, 2010 by SEROVERA

Inflammatory bowel disease is a chronic recurrent disease, which mainly consists of ulcerative colitis and Crohn’s disease, and whose causes are as yet unclear. Many clinical and research studies have indicated that intestinal flora dysbacteriosis contributes to the pathogenesis of ulcerative colitis. Probiotics are non-pathogenic beneficial flora, which have important effects on maintaining the balance of intestinal flora. Many studies have discussed the positive effects of probiotics for treating stomach and intestine diseases, including ulcerative colitis. However, the sample size has been relatively small, such that there is no definitive evidence as to whether probiotics are helpful.

A research team from China systematically evaluated probiotics’ curative effects for treating ulcerative colitis based on existing random control trials. Their study will be published on April 21, 2010 in the World Journal of Gastroenterology.

Through meta-analysis, they concluded that probiotics should be considered as an auxiliary medicine in the remission induction stage and maintenance stage of ulcerative colitis.

Source: World Journal of Gastroenterology

To learn more about the benefits of SeroLife® probiotics, please visit: www.serovera.com

Posted in Crohn's, Crohn's Disease, inflammatory bowel disease, Probiotic | Comments Off

Acne drug linked to bowel disease

Posted on April 8, 2010 by SEROVERA

A drug prescribed to treat severe acne has been freshly linked to an increased risk of bowel disease in some users.A team of researchers at the University of North Carolina Chapel Hill found that patients using isotretinoin were four times more likely than non-users to develop ulcerative colitis within a year, but conceded that the risk of developing the condition is still “likely quite small”.Isotretinoin, otherwise known as Accutane, has been linked to inflammatory bowel disease (IBD) in the past.

Most recently, a former user who claimed that the drug caused his IBD won damages of $25 million from the drug’s manufacturer despite the firm claiming there was no evidence to link the two.The latest study, published in the American Journal of Gastroenterology, found that isotretinoin users were roughly four times more likely than non-users to have ulcerative colitis but found no evidence that it was linked to Crohn’s disease, as initially thought.The researchers, led by Dr Seth D Crockett, analysed the details of 8,189 people on 87 separate US health insurance plans. They compared instances of IBD among isotretinoin users and non-users of equivalent age and sex in order to establish a cause-and-effect relationship between the two.

Source: American Journal of Gastroenterology

Posted in colitis, Crohn's, Crohn's Disease, IBD, inflammatory bowel disease, ulcerative colitis | Comments Off

Smoking and inflammatory bowel diseases: what in smoking alters the course?

Posted on March 26, 2010 by SEROVERA

Epidemiological studies provide strong evidence to confirm the correlation between cigarette smoking and inflammatory bowel diseases. This relationship is proved to be positive in Crohn’s disease and negative in ulcerative colitis. What in smoking alters the course of inflammatory bowel diseases is still a mystery. Different smoking parts have different and may be opponent actions. Smoking has dual effects. Some of its activities are, sometimes, constructive as they are working in an antagonistic manner to the mechanism of the disease, such as reducing rectal blood flow and accordingly less recruitments of inflammatory mediators to the area of inflammation, enhancement of mucosal production, and consequently, strengthening the membranes, and inhibition of pro-inflammatory mediators’ liberation and activity in subjects with ulcerative colitis. Yet the outcome of smoking actions may be affected by the existence of other cofactors. Odd factors, such as shortage of zinc in subjects with Crohn’s disease, may facilitate liberation of pro-inflammatory mediators and their activities and accordingly exacerbates symptoms.

Source:
El-Tawil AM.
Department of Surgery, University Hospital of Birmingham, Birmingham, UK, atawil20052003@yahoo.co.uk.

Posted in colitis, Crohn's, Crohn's Disease, inflammatory bowel diseases, ulcerative colitis | Comments Off

Colonoscopy Not Needed for Most With Irritable Bowel Syndrome

Posted on March 17, 2010 by SEROVERA

People with irritable bowel syndrome (IBS) aren’t at increased risk for polyps, colon cancer or inflammatory bowel diseases, such as Crohn’s disease and, in most cases, don’t require a colonoscopy, U.S. researchers say.

Symptoms of IBS, which affects 10 percent to 20 percent of Americans, include recurrent abdominal pain or cramping in connection with altered bowel habits. The condition is more common among women than men.

“Patients and doctors get nervous about the symptoms of irritable bowel syndrome. They think the symptoms represent something more sinister,” lead author Dr. William D. Chey, professor of internal medicine at the University of Michigan Medical School, said in a news release from the school. “This study should reassure doctors and patients that typical IBS symptoms are not indicators of a more serious disease.”

He and his colleagues conducted the largest evaluation of the results of colonoscopies in IBS patients, they said. About one-quarter of all colonoscopies performed in the United States are for IBS-related symptoms.

Chey and his team concluded that colonoscopies aren’t necessary for typical cases of IBS, unless there is a family history of colorectal cancer or the patient has alarming symptoms such as unexplained weight loss or anemia, or bleeding from the gastrointestinal tract.

“Lay people and doctors overuse colonoscopies, which are very expensive procedures, in patients with typical IBS symptoms and no alarm features. Of course, patients over the age of 50 years or who have alarm features should undergo colonoscopy to screen for polyps and colon cancer,” Chey said.

The researchers did find that 2.5 percent of IBS patients older than 35 had a disease called microscopic colitis, which can be mistaken for IBS in patients with diarrhea. It’s important to diagnose this condition because it requires different treatment than IBS, Chey said.

The study was released online in advance of publication in an upcoming print issue of the American Journal of Gastroenterology.

This article is a reprint of http://www.businessweek.com/lifestyle/content/healthday/637033.html
The time or date displayed reflects when an article was added to Google News March 17. 2010

Posted in colonoscopy, Crohn's, Crohn's Disease, IBS, Irritable Bowel Syndrome | Comments Off

Ulcer Drugs Found to Cause Diarrhea and Colitis

Posted on February 25, 2010 by SEROVERA

People who take widely used acid reflux drugs like Prilosec, Prevacid and Nexium may be trading heartburn for another problem: a potentially dangerous diarrhea caused by Clostridium difficile bacteria.

C-diff, as it’s known, causes severe diarrhea and the intestinal inflammation, colitis.

C-Diff Cases on the Rise

Researchers from McGill University in Montreal studied more than 18,000 patients from 1994 to 2004. They found that the number of C-diff cases has been increasing, from less than one case per 100,000 people in 1994, to 22 per 100,000 in 2004.

What’s more, the researchers found that patients taking prescription heartburn drugs had a much higher risk than those who did not. The drugs reduce levels of gastric acid that control C-diff bacteria. The study found:

•Patients taking proton pump inhibitors (Prilosec and Prevacid) were almost three times more likely to have a C-diff infection than non-users.
•Patients taking H2 receptor antagonists (Pepcid and Zantac) were twice as likely to have a C-diff infection.
Antibiotics and Hospitalization Also Risks

People who are hospitalized, and those on antibiotics, also have a higher risk of C-diff infection.

But while some blame the increasing number of C-diff infections on overuse of antibiotics, the new study points to overuse of acid-fighting drugs as another likely culprit.

Source:
http://jama.ama-assn.org/cgi/content/short/294/23/2989

Posted in Acid Reflux, colitis, intestinal inflammation, Nexium, Prevacid | Comments Off

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