Friday, November 13, 2009

Tranexamic Acid (Lysteda) Approved for the Treatment of Heavy Menstrual Bleeding

The U.S. Food and Drug Administration today approved tranexamic acid (Lysteda tablets), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods. But in most cases, there is no underlying health condition associated with the condition.

“Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, M.D., FDA’s associate commissioner of women’s health. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.”

Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron (Pfizer), and is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood clotting factor.

The most common adverse reactions reported during clinical trials by patients using Lysteda included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill (placebo).

Use of tranexamic acid while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, according to Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. Women using hormonal contraception should take tranexamic acid only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk.

Tranexamic Acid (Lysteda) is manufactured by Xanodyne Pharmaceuticals of Newport, Ky, an integrated specialty pharmaceutical company with both development and commercial capabilities focused on pain management and women's healthcare. The company, founded in 2001 markets a portfolio of prescription pharmaceuticals and a line of prenatal vitamins.

Potential Health and Safery Concerns Results in FDA Probe of Caffeinated Alcoholic Beverages

The US Food and Drug Administration (FDA) today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS. For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned. To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use.

In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.

Monday, September 28, 2009

Annual EU healthcare index puts The Netherlands in “uncontested leadership”

The Netherlands win the 2009 Euro Health Consumer Index (EHCI), for the second year in a row - the first time this happens since the EHCI started in 2005 - and with an outstanding margin. Nevertheless, Denmark keeps its runner-up position from last year.

Besides the Dutch and Danish system there is a small group of strong performers: Iceland, Austria and Switzerland.There are general improvement trends among most of the measured healthcare systems, with examples of reform making impact not only in Netherlands but in Ireland and the Czech Republic as well.

There is continuous decline in the Spanish, Portuguese and Greek healthcare systems which do not keep up with the improvement rate one can find in countries like the Netherlands, Denmark or Ireland. Large parts of Eastern and Central Europe seem to be affected by the financial crisis.

The HCP research director, Dr. Arne Bjornberg, comments on the EHCI 2009 outcomes: "As the Netherlands are expanding their lead among the best performing countries, the Index indicates that the Dutch might have found a successful approach. It combines competition for funding and provision within a regulated framework. There are information tools to support active choice among consumers.

The Netherlands have started working on patient empowerment early, which now clearly pays off in many areas.Johan Hjertqvist, President of Health Consumer Powerhouse, commented: "With patient mobility growing around Europe, there is a strong need for transparency exposing the pros and cons of the national healthcare systems. The EU intends to introduce a crossborder care scheme which requires significantly better information to patients. This years´ measurement indicates that forward-looking governments start using healthcare information and choice to engage patients in the decision-making, building a pressure from below for improvement".

EHCI categories
The EHCI 2009 groups 38 indicators of quality into six categories: Patient rights and information, e-Health, Waiting time for treatment, Outcomes, Range and reach of services provided and Pharmaceuticals. Each sub-discipline is weighted for importance to provide the overall Index score.The individual category leaders were as follows:
  • Patient rights and information: Denmark
  • e-Health: Denmark, Netherlands
  • Waiting time for treatment: Albania, Belgium, Germany, Switzerland
  • Outcomes: Sweden
  • Range and reach of services provided: Belgium, Luxembourg, Sweden
  • Pharmaceuticals: Denmark, Netherlands

The 2009 EHCI is developed in co-operation with the European Commission DG Information Society and Media and works under the auspices of the Swedish EU Presidency.

Friday, September 25, 2009

Obesity Causes More than 124,000 New Cancers a Year in Europe

According to estimates from a new modeling study, at least 124,000 new cancers in 2008 in Europe may have been caused by excess body weight. The proportion of cases of new cancers attributable to a body mass index of 25kg/m2 or more were highest among women and in central European countries such as the Czech Republic, Latvia, Slovenia and Bulgaria.

The lead author of a study called ‘Incident cancer burden attributable to excess body mass index in 30 European countries’, published in the International Journal of Cancer, Dr Andrew Renehan, told oncologists and other medical professionals gather together in Berlin, Germany during the combined 15th congress of the European CanCer Organisation and the 34th congress of the European Society for Medical Oncology: “As more people stop smoking and fewer women take hormone replacement therapy, it is possible that obesity may become the biggest attributable cause of cancer in women within the next decade.”

Dr Renehan, who is a senior lecturer in cancer studies and surgery at the University of Manchester (UK), and his colleagues in the UK, The Netherlands and Switzerland, created a sophisticated model to estimate the proportion of cancers that could be attributed to excess body weight in 30 European countries. Using data from a number of sources including the World Health Organization and the International Agency for Research on Cancer, they estimated that in 2002 (the most recent year for which there are reliable statistics on cancer incidence in Europe) there had been over 70,000 new cases of cancer attributable to excess BMI out of a total of nearly 2.2 million new diagnoses across the 30 European countries.

The percentage of obesity-related cancers varied widely between countries, from 2.1% in women and 2.4% in men in Denmark, to 8.2% in women and 3.5% in men in the Czech Republic. In Germany it was 4.8% in women and 3.3% in men, and in the UK it was 4% in women and 3.4% in men.

Then, the researchers projected the figures forward to 2008, taking into account what was known about shifts in the distribution of BMI, the dramatic decline in women’s use of hormone replacement therapy (HRT) from 2002 onwards following research that showed it increased the risk of breast cancer, and the wider use of PSA screening for prostate cancer in men.

They found that the number of cancers that could be attributed to excess body weight increased to 124,050 in 2008. In men, 3.2% of new cancers could be attributed to being overweight or obese and in women it was 8.6%. The largest number of obesity-related new cancers was for endometrial cancer (33,421), post-menopausal breast cancer (27,770) and colorectal cancer (23,730). These three accounted for 65% of all cancers attributable to excess BMI.

“I must emphasize that we are trying not to be sensationalist about this,” said Dr Renehan. “These are very conservative estimates, and it’s quite likely that the numbers are, in fact, higher.”

The number of new cases of obesity-related esophageal cancer was particularly high in the UK relative to the rest of Europe. “This country accounts for 54% of new cases across all 30 countries,” said Dr Renehan. “This may be due to synergistic interactions between smoking, alcohol, excess body weight and acid reflux – and is currently an area where research is required.”

Until 2002 when HRT use dropped dramatically following the results of the Women’s Health Initiative Trial (USA) that showed an increased risk of breast cancer in women taking HRT, Dr Renehan said that HRT masked and diluted the effects of obesity on the incidence of breast cancer. “In women who used HRT it wasn’t clear what proportions of breast cancers were caused by HRT or by obesity. In women who don’t take HRT, the effect of obesity was much clearer. Now that far fewer women are using HRT, it is much easier to see the effect of obesity on the incidence of breast cancer, and also on endometrial cancer. Consequently, the proportions of these cancers attributable to obesity have increased.”

Dr Renehan said that although European countries were taking steps to tackle the obesity epidemic, this study underlined the urgency of the task and the scale of the problems caused by increasingly overweight populations.

“The overall size of the burden of increasing cancer incidence should inform health policy. For example, it is clear that, in both relative and absolute terms, obesity-related cancer is a greater problem for women than for men. At a country level, it is a greater problem for central European countries like the Czech Republic, whereas it is less of a problem in France and Denmark. Similarly, obesity-related esophageal cancer seems to be a substantial and unique problem in the UK.

“The study also identifies priorities for research into certain cancers, namely endometrial, breast and colorectal cancers. In the face of an unabating obesity epidemic, and apparent failure of public health policies to control weight gain, there is a need to look at alternative strategies, including pharmacological approaches.”

Dr Renehan’s own research is trying to relate these epidemiological findings back to the biological mechanisms that are at work. His research uses the observed interactions between excess BMI and cancer risk to guide questions in the laboratory.

For more information:
  • ECCO15 – ESMO 34 Abstract no: 327, Oncopolicy session: Drug and lifestyle mediated prevention initiatives in Europe. Thursday 11.15-12.15 hrs CEST (Hall 3)

Friday, September 18, 2009

Survey Shows that Diabetic Nerve Pain Significantly Impacts Daily Activities

In a new online survey conducted among 553 men and women, 18 and older who have either type I or II diabetes and are suffering from diabetic nerve pain in the United States, eighty-five percent said that their pain was one of the top three most bothersome complications of their diabetes.

Despite the fact that people with diabetic nerve pain recognize the condition's impact on their lives and eighty-four percent of those surveyed said they have discussed the condition with a healthcare provider, just slightly less than half of respondents (49 percent) were treating their pain.

The survey was fielded as part of a new educational campaign, "Take the Next Step," which is designed to help people with diabetes recognize the symptoms of painful diabetic peripheral neuropathy (pDPN) and proactively talk to their healthcare professional about incorporating the treatment of pDPN into their overall diabetes care, which may include blood sugar control, diet, pain management, exercise or other changes in lifestyle. The initiative is supported through a sponsorship by Pfizer Inc.

Taking Control of Your Diabetes (TCOYD), a leading non-profit organization dedicated to educating people about diabetes, and Kim Lyons, personal trainer and nutritionist featured on NBC's hit show, "The Biggest Loser," are participating in this campaign to raise awareness of pDPN, one of the most common and debilitating complications of diabetes. "Take the Next Step" features an activity program developed by Lyons to demonstrate activities that are appropriate for people with diabetes and help people with pDPN understand how increasing their activity level can help them control their pain.

"Optimal blood sugar control has been shown to prevent the onset and delay the progression of pDPN and ease its symptoms," said Steven Edelman, MD, Founder and Director of the not-for-profit 'Taking Control of Your Diabetes' and Professor of Medicine, University of California at San Diego. "Given the debilitating impact of pDPN, such as on a person's ability to be physically active and to fall asleep at night, treating the pain can really make a difference for these patients and help them get back to normal daily activities which in turn can help them better manage their diabetes."

Many patients are unaware of treatment options.
Of the people surveyed, almost two-thirds (64 percent) said that their nerve pain interfered with the daily activities that matter to them. The most common activities that respondents said were impacted by their pain were exercising (76 percent), falling asleep (71 percent) and spending time with or caring for family (68 percent). Of the more than half of those surveyed who were not being treated (51 percent), less than a third (32 percent) were aware of treatments that are approved to treat the condition.

Currently, nearly 24 million Americans suffer from diabetes. Approximately 20 percent of people with diabetes experience painful diabetic peripheral neuropathy, most commonly caused by poorly controlled blood sugar levels that result in nerve damage over time. Symptoms of pDPN may include burning, throbbing or painful tingling in the feet or hands.

The pain associated with the condition can become extremely debilitating, affecting patients' everyday activities such as the motivation needed to exercise and be active and the ability to fall asleep. Difficulty maintaining an active lifestyle can hamper patients' ability to control their weight, an important key to diabetes management. Treatment guidelines point to the unique nature of pDPN and the need for specialized treatment, which can include prescription treatment for the pain.

"I was motivated to be a part of this campaign because I've seen the benefits of activity for people who suffer from pDPN," said Kim Lyons. "I know that for people with this kind of pain, engaging in physical activity might seem daunting at first, but people will be amazed to see that taking small steps towards increasing activity level can make a big difference."

Prevention, early diagnosis and aggressive treatment are critical
People with diabetes can develop nerve pain at any time, but the risk is greater the longer a person has suffered from diabetes, with the highest rates among those who have had the condition for at least 25 years. In the early stages of nerve damage, some people have no symptoms, or may have numbness or tingling in the feet. These symptoms can be mild at first and because nerve damage can occur over several years, these cases may go unnoticed until the nerve damage progresses and becomes painful, sometimes leading to painful diabetic peripheral neuropathy (pDPN).

A number of prescription medications are approved by the U.S. Food and Drug Administration (FDA) to help relieve the specific symptoms of pDPN. These medications can play an important role in helping to reduce the pain associated with this condition. Over-the-counter pain medicines such as acetaminophen and ibuprofen are frequently used, but have not been specifically approved by the FDA to treat painful diabetic peripheral neuropathy.

For more information:

Wednesday, September 16, 2009

Introducing a More Powerful WIN CoQ10™

Vitaelin Nutraceuticals today introduced the new and improved WIN CoQ10™ packs a powerful punch with its new size.

WIN CoQ10™ contains the most advanced, form of CoQ10 available, ubiquinol, which plays a vital role in energy production. Additionally, this ubiquinol form is an active antioxidant protecting the body’s cells from damage caused by oxidative stress and free radicals. Experience new sustained energy and promote your overall health with WIN CoQ10™ .

WIN CoQ10™ is a nutritional supplement containing ubiquinol, the reduced form of coenzyme Q10, which has been shown to help lower blood pressure and improve symptoms related to heart disease and may help improve brain functioning. Additionally, WIN CoQ10™ may help restore coenzyme Q10 which can be lost when taking certain medications to lower cholesterol levels, such as statins, and dietary supplements containing red yeast rice. Maintaining coenzyme Q10 levels are essential as coenzyme Q10 is a critical component of energy metabolism at the cellular level. WIN CoQ10™ 's protective effect on the heart may slow the aging of cells associated with the cardiovascular system.

WIN CoQ10™ 's 100% natural, high-absorption formula is far superior to most CoQ10 supplements because they primarily consist of ubiquinone which isn’t as easily absorbed by the body. Studies show WIN CoQ10™ absorption rate is 8 times higher than supplements with ubiquinone and maintains higher levels of CoQ10 in the blood over time. It took 2400mg of ubiquinone to reach the same level of CoQ10 in the bloodstream with only 300mg of WIN CoQ10™ 's ubiquinol formulation.

WIN CoQ10™ may:

  • Support and maintain energy production
  • Promote heart health
  • Help prevent free radical damage
  • Help protect against oxidative stress
  • Maintain healthy, normal blood pressure
  • Help manage the entire circulatory system
  • Promote a healthy immune system
  • Maintain healthy neurological function

Studies show WIN CoQ10™ formula additionally supports periodontal tissue well-being, musculoskeletal health and the body’s natural defense system.

Now More Powerful
WIN CoQ10™ now includes a new, patent-pending crystal free technology, WIN-CFT™, which provides a clearer appearance and improves CoQ10’s absorption rate within the body. The solution featuring D-Limonene oil helps better protect ubiquinol from oxidization. When oxidization does occur, ubiquinol crystallizes resulting in a cloudy, opaque appearance. By keeping the CoQ10 solubilized, things start to look much clearer and the required amount of oil solution is halved, providing us with a smaller soft gel, all while improving CoQ10 bioavailability within the body.

WIN CoQ10™ now also contains a versatile antioxidant called alpha lipoic acid (ALA) to help extend CoQ10’s energy production benefits.Though its appearance is a little different, the new and improved WIN CoQ10™ is still filled with 50 mg of the most advanced, high-absorption form of CoQ10 available with WIN-CFT™ maximizing its absorption rate.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, mitigate or prevent any specific disease or class of diseases.

Wednesday, September 9, 2009

Obesity Driving America's Healthcare to a Tipping Point

The Obesity Society, a leading scientific organization dedicated to the study of obesity, and other steering committee members of the Strategies to Overcome and Prevent (STOP) Obesity Alliance, and two former US Surgeons General, join together today to develop effective recommendations to urge policymakers to act on the inclusion of obesity as the largest and most urgent driving factor in healthcare reform.

The two most recent Surgeons General of the United States, David Satcher MD, PhD and Richard H. Carmona, MD, MPH, respectively 16th and 17th US Surgeons General, jointly urged policymakers to take direct action on obesity and its associated chronic diseases by including obesity as a key element in healthcare reform.

"Health reform will succeed only if we address obesity and the chronic diseases it causes," said Robert Kushner, MD, President of The Obesity Society. "Obesity is the number 1, most serious health issue facing the country. It is also the largest single driver of our increasing healthcare costs and we need to address it now."

More than one third of US adults -- more than 72 million people -- and 16 percent of US children are now estimated to be overweight or obese. Obesity and overweight are associated with several chronic health risks and conditions, including: diabetes, heart disease, stroke, hypertension, some types of cancer, sleep apnea, osteoarthritis, and gallbladder disease. Furthermore, the medical costs of obesity are now estimated at more than $147 billion per year.

The Obesity Society supports the four targeted recommendations for effective healthcare reform issued by the STOP Obesity Alliance at the meeting held today at the Newseum in Washington, DC:

  • Standardized and effective clinical interventions, flowing from evidence-based guidelines, such as those approved by the National Heart, Lung and Blood Institute (NHLBI), that include acknowledging the health benefits of five to ten percent sustained weight loss to
    aid and support those individuals who are currently overweight or obese achieve improved health.
  • Enhanced use of clinical preventive services to monitor health status and help prevent weight gain, especially for individuals who are already overweight and are at risk of becoming obese.
  • Effective, evidence-based community programs and policies that encourage and support healthy lifestyles, focus on health literacy, address health disparities, and represent a significant investment in population-based prevention of obesity.
  • Coordinated research efforts to build the evidence for all three of the above elements, continuously improving quality of care, bolstering our understanding of what does and does not work in various settings, and helping to translate the scientific research into practice
    recommendations for real-world clinical settings and communities.

"These recommendations are designed to improve the dialogue and interventions around obesity. Successful reform will address clinical treatment, prevention, community programs and research to reverse the medical burden of obesity," said Dr. Kushner. "Lending our support to the STOP Obesity Alliance recommendations will also bring us one more step closer to providing a health system that can effectively lessen the grip of obesity on our society."

For more information:

Tuesday, September 8, 2009

Simple ABCs of Weight Loss and Fitness: Advice From Someone who Knows

Modern American society is filled with easily accessible fatty foods, a growing obesity epidemic and a general lack of healthy living. In his new book,Lose Weight, Feel Great: How I Lost Over 60lbs. with the Help of a Personal Trainer,author Kevin Given tells of his personal struggles with obesity, how he lost over 60 pounds with the help of a personal trainer, and how others can change their lifestyles and bodies as well.

Says Given 'This book is different from other weight loss books because it is my personal story of how I overcame the obstacle of obesity. I also avoid going into unnecessary detail. I find that most problems with weight loss books are that they get bogged down with details on how certain things work. My book cuts to the chase and makes it simple. "If you do this, then this is what will happen."

Given Continues: "If you eat certain foods, this is how they will affect your system. If you do a certain exercise; for example dumb-bell curls, then this is what will happen; your biceps will develop. There are no unnecessary details here that will only slow you down. In my book you will find the simple ABCs of weight loss and fitness."

Given had ongoing issues with his weight for over 20 years with many failed attempts at change. He tried numerous fad diets that never worked, so he then decided to hire a personal trainer to aid him in losing weight and keeping it off for good. Now a certified personal trainer himself, Given hopes to help others through a combination of historical knowledge of human health, personal testimony, exercises and fitness techniques, nutrition, and other information vital to weight loss and good health.

While the use of this book and practicing a healthy lifestyle are certainly reliable ways to lose weight and get in shape, Given also believes the aid of a personal trainer helps immensely in this journey toward the ideal you.

"If the military sent a soldier to basic training with only an army manual and no guidance, that soldier wouldn't learn much! How many soldiers would get up at four or five AM without the drill sergeants going through the hall with a stick and a garbage can banging as loudly as he or she can? Who would be motivated to do pushups if the drill sergeant didn't yell, "Drop and give me twenty"? Just as the soldier is guided to his peak performance during army basic training, so an individual seeking to get into better shape will be guided by the personal trainer into reaching his/her goal", Given explains.

Monday, August 24, 2009

Ongoing Safety Review of Weight Loss Drug Orlistat

The U.S. Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical (orlistat 120 mg) and the over-the-counter medication Alli (orlistat 60 mg).

The drugs were approved for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury, including 6 with liver failure, in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

Reports outlining the adverse events were submitted to FDA’s Adverse Event Reporting System.The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.The FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time.

Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.Consumers who have used orlistat should consult a health care professional if they experience symptoms possibly associated with development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine.

Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.The FDA urges both health care professionals and consumers to report suspected side effects from the use of orlistat to FDA's MedWatch Adverse Event Reporting program

Further information regarding orlistat will be released by the FDA as soon as its review of complete.

Orlistat is manufactured by Swiss pharmaceutical firm Roche. The drug is marketed as Alli by British drugmaker GlaxoSmithKline PLC and sold as Xenical by Roche. The FDA first approved Xenical in 1999 and alli in 2007. Glaxo reported $123 million in sales for Alli in 2008, while Roche posted $472 million in revenue for Xenical.

Friday, July 10, 2009

Dietary Supplement and Protein Powder Manufacturers Companies Failed to Declare Allergens in Products

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.

The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.

The government's complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.

Undeclared Ingredients

The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.

During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.

FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

Failing to correct filthy conditions

In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.

“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”

Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.

Thursday, January 29, 2009

Weight Loss in Overweight and Obese Women Reduces Urinary Incontinence

Reducing urinary incontinence can now be added to the extensive list of health benefits of weight loss, according to a clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Office of Research on Women’s Health (ORWH), both part of the National Institutes of Health (NIH). The paper reporting the results of the trial will be published in the January 29 issue of the New England Journal of Medicine.

The Program to Reduce Incontinence by Diet and Exercise (PRIDE), conducted in Birmingham, Alabama, and Providence, Rhode Island, recruited a total of 338 obese and overweight women who leaked urine at least 10 times per week. The women were randomly assigned to either an intensive six-month weight-loss program of diet, exercise and behavior modification (226 women) or to a group that received information about diet and exercise, but no training to help them change habits (112 women).

The investigators report that women in the intensive weight-loss group lost an average 8 percent of their body weight (about 17 pounds) and reduced weekly urinary incontinence episodes by nearly one-half (47 percent). In contrast, women in the information-only group lost an average 1.6 percent of body weight (about 3 pounds) and had 28 percent fewer episodes.
'Clearly, weight loss can have a significant, positive impact on urinary incontinence, a finding that may help motivate weight loss, which has additional health benefits such as preventing type 2 diabetes,' said NIDDK Director Griffin P. Rodgers, M.D.

Urinary incontinence affects more than 13 million women in the United States and accounts for an estimated $20 billion in annual health care costs, according to the paper. Obesity is an established and modifiable risk factor for urinary incontinence, but conclusive evidence for a beneficial effect of weight loss on urinary incontinence has been lacking. The PRIDE trial provides evidence supporting weight loss as a treatment for incontinence.

An important finding of the study is the difference between the two groups in the reduction of incontinence. Among women in the weight-loss group, 41 percent achieved a clinically relevant reduction of at least 70 percent of total incontinence episodes per week, whereas 22 percent of women in the information-only group achieved the same level of reduction.

At six months, women in the weight-loss group were significantly more satisfied with the change in their incontinence than were women in the information-only group. This was assessed through self-reported perceived change in frequency of incontinence, volume of urine loss, the degree to which incontinence was a problem, and satisfaction with the change in incontinence.

'Studies have documented that behavioral interventions help people lose weight, which helps decrease the risk of developing type 2 diabetes and high blood pressure, improve control of high blood pressure and cholesterol levels, and enhance mood and quality of life,' explained Leslee L. Subak, M.D., of the University of California, San Francisco (UCSF) and lead author of the study. 'Our results suggest that a decrease in urinary incontinence is another health benefit associated with weight loss and that weight reduction can be a first-line treatment in overweight and obese women.'

Results from previous studies suggest that a weight loss of 5% to 10% has an efficacy similar to that of other nonsurgical treatments and should be considered a first line therapy for incontinence.

Weight loss in PRIDE is comparable to that observed in the Diabetes Prevention Program (DPP) and in the ongoing Action for Health in Diabetes (Look AHEAD), two NIDDK-sponsored clinical trials in people with type 2 diabetes. The PRIDE intensive weight-loss program was modeled after these two trials.

In an interview, earlier today, the investigators noted that while the results of the study indicated that incontinence diminished in both groups, they believe that some of reduced incontinence in the 'information-only group' is based on adopting some of the additional techniques included in the educational materials.

Because weight loss and weight maintenance can be highly challenging for the individual patient, clinicians are encouraged to help their patients by identifing a number of appropriate local or online resources to which they can refer patients for additional support.

For more information:

Also read:

Also read PubMed abstracts:

Wednesday, January 21, 2009

More Americans Report Being Obese

An estimated 25.6 percent of US adults reported being obese in 2007 compared to 23.9 percent in 2005, an increase of 1.7 percent. And this number is climbing. In three states, the prevalence of self-reported obesity among adults age 18 or older was above 30 percent. None of the 50 states or the District of Columbia has achieved the Healthy People 2010 goal to reduce obesity prevalence to 15 percent or less.

The proportion of US adults who self-report they are obese increased nearly 2 percent between 2005 and 2007. An estimated 25.6 percent of US adults reported being obese in 2007 compared to 23.9 percent in 2005, an increase of 1.7 percent. The report also finds that none of the 50 states or the District of Columbia has achieved the Healthy People 2010 goal to reduce obesity prevalence to 15 percent or less.

In three states - Alabama, Mississippi, and Tennessee - the prevalence of self-reported obesity among adults age 18 or older was above 30 percent. Colorado had the lowest obesity prevalence at 18.7 percent. Obesity is defined as a body mass index (BMI) of 30 or above. BMI is calculated using height and weight. For example, a 5-foot, 9-inch adult who weighs 203 pounds would have a BMI of 30, thus putting this person into the obese category.

The data were derived from CDC's Behavioural Risk Factor Surveillance System, a state-based telephone survey that collects information from adults aged 18 years and older. For this survey more than 350,000 adults are interviewed each year, making BRFSS the largest telephone health survey in the world. BMI was calculated based on this self-reported information.

'The epidemic of adult obesity continues to rise in the United States indicating that we need to step up our efforts at the national, state and local levels,' said Dr William Dietz, director of CDC's Division of Nutrition, Physical Activity, and Obesity. 'We need to encourage people to eat more fruits and vegetables, engage in more physical activity and reduce the consumption of high calorie foods and sugar sweetened beverages in order to maintain a healthy weight.'

The study found that obesity is more prominent in the South, where 27 percent of respondents were classified as obese. The percentage of obese adults was 25.3 in the Midwest, 23.3 percent in the Northeast, and 22.1 percent in the West.

By age, the prevalence of obesity ranged from 19.1 percent for men and women aged 19-29 years to 31.7 and 30.2 percent, respectively, for men and women aged 50-59 years.

'Obesity is a major risk factor for a number of chronic diseases such as type 2 diabetes, heart disease and stroke. These diseases can be very costly for states and the country as a whole,' said Deb Galuska, associate director for science for CDC's Division of Nutrition, Physical Activity and Obesity.

For more information on how you can combat obesity, contact your doctor or visit the information site from the CDC.

Tuesday, January 13, 2009

New enzyme let mice to gorge without becoming obese, new study finds.

Researchers at the University of California, Berkeley, California, have zeroed in on an enzyme that plays a key role regulating metabolism and weight in mCursiefice and say a drug that inhibits this target could do the same for people. The new enzyme plays a far more important role than expected in controlling the breakdown of fat. The findings of their study have been published in the January 11, 2009 edition of Nature Medicine. One of the remarkable findings reported by the researchers is that mice that have had this enzyme disabled remained lean despite eating a high-fat diet and losing a hormone that suppresses appetite.

'We have discovered a new enzyme within fat cells that is a key regulator of fat metabolism and body weight, making it a promising target in the search for a treatment for human obesity,' said Hei Sook Sul, UC Berkeley professor of nutritional sciences and toxicology and principal investigator of the research.

Sul's research team also includes the three co-lead authors of the paper, all from UC Berkeley's Department of Nutritional Sciences and Toxicology, Kathy Jaworski, former post-doctoral researcher, Maryam Ahmadian, graduate student, and Robin Duncan, post-doctoral fellow.

The enzyme in the spotlight, adipose-specific phospholipase A2 (AdPLA), is found in abundance only in fat tissue. AdPLA sets off a chain of events that increases levels of a signaling molecule called prostaglandin E2 (PGE2), which suppresses the breakdown of fat. Mice that have no AdPLA have lower PGE2 levels and a higher rate of fat metabolism.

'When levels of PGE2 are decreased because of the lack of AdPLA, fat breakdown proceeds unchecked, resulting in leanness even in animals that eat all day long,' said co-lead author Duncan.

In the study, mice that had the gene for AdPLA expression knocked out were compared with a control group of normal mice. As soon as the mice were weaned at about 3 weeks of age, researchers began offering the two groups of mice an all-you-can-eat buffet of tasty, high-fat foods.

Notably, the enzyme did not appear to affect appetite since the two groups ate equivalent amounts. However, as the mice aged, the disparity in weight gain became clear. By 64 weeks of age - considered the twilight years in a lab mouse's lifespan - the mice that lacked the AdPLA enzyme averaged only 39.1 grams, a weight more typical of a low-fat diet, while the control mice weighed in at a hefty 73.7 grams.

No reduction in fat cells
The researchers noted that the missing AdPLA did not change the number of fat cells, but simply kept the cells from accumulating excess fat. The researchers also studied whether loss of AdPLA could prevent genetic obesity in mice. They compared mice that lacked leptin, the hormone that signals when the body is full, with mice that lacked both AdPLA and leptin. Leptin-deficient mice are voracious eaters, typically consuming two to three times more food per day than normal mice, and they rapidly develop obesity.

Increase AdPLA
In this study, leptin-deficient mice ate an average of 5 grams of food per day, while mice that lacked both AdPLA and leptin ate 7.5 grams. Typically, normal mice will eat only 2-3 grams per day. By 17 weeks of age, the leptin-deficient mice were already hitting the scales at 75 grams. In comparison, mice that lacked both AdPLA and leptin weighed just under 35 grams.
The researchers found that levels of AdPLA increase after eating to block fat breakdown, and decrease with fasting to allow fat breakdown to proceed efficiently. They also found that levels of AdPLA are higher in obese mice.

'This means that local signals in fat tissue allow fat cells to directly regulate fuel provision for the body, which changes our fundamental understanding of how the body regulates fat breakdown,' said Ahmadian, another study co-lead author. 'We found that mice deficient in AdPLA expend more energy than normal mice, and they also burn more fat directly within fat cells.'

Before this paper, the assumption had been that the major players in controlling fat metabolism and body weight were endocrine factors, primarily hormones that are secreted by different organs and glands and travel through the bloodstream to fat tissue, the authors said.

The new findings show that a large portion of the action is occurring within the actual fat tissue, mainly through the autocrine and paracrine action of PGE2 that acts locally within a cell or small group of cells.

How research translates
The researchers caution that previous discoveries in fat metabolism and appetite regulation have not always translated well from mice to humans. Although some people have mutations in the gene that codes for AdPLA, it remains to be seen what effect these mutations have in humans, they said.

They also noted that inhibiting the expression of AdPLA in mice led to greater insulin resistance and a four-fold increase in fat content in the liver. However, tests of liver function were largely normal.

Nevertheless, AdPLA may become an attractive target in developing a treatment to combat obesity, the researchers said. If excess fat can be burned before it escapes the fat cell, it can never get into the bloodstream to negatively affect other organs, such as the heart.

'We believe that the effects in the liver are due to the extremely high rate of fat breakdown and drastic leanness in these mice, so we are looking to see if reducing rather than completely eliminating AdPLA can provide effective protection against obesity without secondary effects,' said Duncan.

For aditional information:
Also read PubMed abstracts:

Tuesday, December 23, 2008

Tainted Weight Loss Pills Put Consumers’ Health at Risk

Earlier this week, the U.S. Food and Drug Administration (FDA) alerted consumers in North America not to purchase or consume one of more than 25 different products marketed for 'weight loss' because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk and lead to such health problems as high blood pressure, seizures, heart attack, or stroke.

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products, often marketed as ‘dietary’or ‘food supplements,’ include sibutramine (a controlled substance, manufactured and legally distributed by Abbott Laboratories as Meridia in the U.S. and Canada, and Reductil in Europe and most other countries), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels.

Prescription drugs vs. supplements
The Dietary Supplement Health and Education Act, commonly known as DSHEA, does not qualify dietary or food supplements as ‘drugs’ As a result, many of these products fall outside the realm of the FDA regulations for (prescription) drugs. While pharmaceutical companies must meet rigorous conditions for manufacturing, packaging, labeling, advertising and distribution of prescription drugs, dietary and food supplements do not require any proof. However, supplement labels are supposed to exactly state what’s in the product. Unfortunately, as this FDA analysis shows, this is not always the case.

While prescription drugs are monitored by the FDA, the agency does not monitor ‘dietary’or ‘food supplements’ as they do prescription drugs. In this case however, the FDA warned against the use of supplements contaminated with a variety of unlisted pharmaceuticals. Some of these active pharmaceutical ingredients may be approved for marketing as prescription drugs in the United States or Europe. However, the fact that these products are not listed as ingredients on the supplement product labels, as required by law, or exceeds recommended dosage levels, is a violation of existing regulations and a major concern to medical authorities. Dr Robert Mayr, an internationally recognized expert on dietary supplements, noted that: ‘There is a real danger that these ‘weight loss pills’ are putting consumers' health at risk.’

These weight loss products are often promoted and sold on web sites and in some retail stores. Some of the products claim to be ‘natural’ or to contain only ‘herbal’ ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. Therefor, these products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their health care professional immediately. The FDA encourages consumers to seek guidance from a health care professional before purchasing weight loss products.

‘These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,’ said Dr Janet Woodcock, MD., director, Center for Drug Evaluation and Research, FDA. ‘Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.’

The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA's inspections and the companies' inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

In October 2008 the European Medicines Agency (EMEA) completed a review of rimonabant following concerns over the medicine’s psychiatric safety. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of rimonabant no longer outweigh its risks, and that its marketing authorisation should be suspended across the European Union (EU). Following these conclusions, Sanofi-Aventis, in November 2008, decided to discontinue the ongoing rimonabant clinical development program in all indications.

When in doubt...
Consumers in doubt about any ‘weight loss’ or dietary supplement they are currently using, should make sure to contact the manufacturer or distributor listed on the label. In all cases, health care professionals and consumers should report serious adverse events or side effects and product quality problems to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

The tainted weight loss products include the following products and brands:

  • Fatloss Slimming
  • 2 Day Diet
  • 3x Slimming Power
  • Japan Lingzhi 24 Hours Diet
  • 5x Imelda Perfect Slimming
  • 3 Day Diet
  • 7 Day Herbal Slim
  • 8 Factor Diet
  • 7 Diet Day/Night Formula
  • 999 Fitness Essence
  • Extrim Plus
  • GMP
  • Imelda Perfect Slim
  • Lida DaiDaihua
  • Miaozi Slim Capsules
  • Perfect Slim
  • Perfect Slim 5x
  • Phyto Shape
  • ProSlim Plus
  • Royal Slimming Formula
  • Slim 3 in 1
  • Slim Express 360
  • Slimtech
  • Somotrim
  • Superslim
  • TripleSlim
  • Zhen de Shou
  • Venom Hyperdrive 3.0

Wednesday, December 3, 2008

A delicious new, low-carb, low-calorie and sugar-free energy drink hits the market.

Having trouble getting started in the morning? Need more energy? At Vitaelin Nutraceuticals , a distributor of the top-quality weight management line BioLean® System and highly-concentrated Omega-3 supplement WINOmeg3complex™, we’re thrilled to meet the demands of the busy, overworked and tired by launching our new, low-calorie, low-carb and sugar-free Winrgy®, a revolutionary new energy and mental performance drink. The new sugar-free Winrgy® is an ideal energizer during stressful activities, while traveling long distances, or anytime peak performance is needed. This new energy drink delivers instant, long-lasting energy and mental performance without the crash or jitters.

Through nutrients in the diet, nerves are able to send signals throughout the body called neurotransmitters. One such neurotransmitter, noradrenaline, provides individuals with the necessary alertness and energy required in day-to-day activity. A unique blend of vitamins and minerals important to the creation of noradrenaline has been incorporated into new sugar-free Winrgy®, making it a delicious, invigorating, citrus-flavored energy drink, a nutritional alternative to coffee, cola and other soft-drinks.

Along with caffeine, vitamin C, vitamin B6, vitamin E, thiamin riboflavin, niacin and folate (as folic acid), new sugar-free Winrgy® contains taurine (2-aminoethanesulfonic acid), which is an essential amino acid found in many of the body's organs to aid digestion.

Studies reveal that vitamin B2 (riboflavin) helps the body release energy from protein, carbohydrates and fat, while vitamin B12 (cobalamin) is given to combat fatigue and alleviate neurological problems, including weakness and memory loss. Another important component of new sugar-free Winrgy®, vitamin B3 (niacin), works with both thiamin and riboflavin in the metabolism of carbohydrates and is essential for providing energy for cell tissue growth. Niacin has also proven to dilate blood vessels and thereby increase blood flow to various organs of the body, sometimes resulting in a blush of the skin and a healthy sense of warmth. Unlike caffeine, new sugar-free Winrgy® offers all the raw materials necessary to continue the production of noradrenaline and is ideal for anytime performance is required.

A growing market
New Sugar-free Winrgy® is an instant gratification drink that gives consumers mental clarity and lasting stamina without the jitters or crash. Today’s busy lifestyle has recently driven the energy drink market to incredible, explosive growth. Since 2000, sales volume for energy drinks have increased by an impressive 75 percent and increased in value by 71 percent, with sales reaching $6.1 billion in 2005 alone. In addition, the combined sports food and drink market grew an impressive 48 percent between 2000 and 2005, making it one of the highest growth rates among all food and beverage categories.

The demands of professional athletes to weekend warriors require high levels of energy, and Winrgy® delivers an energetic, competitive edge along with mental focus. After two hours of participating in sports or working out, muscle glycogen is depleted and fatigue can set in, leading to reduced recovery, poor quality training and chronic fatigue. Winrgy® can instantly increase glycogen levels and maintain energy levels of athletes for four to six hours. Athletes can also hydrate with Winrgy® to help avoid dehydration, which can lead to reduced mental function and performance, poor decision making, anticipation and skill delivery. An ideal energizer during demanding activities, Winrgy® helps maintain energy and mental fitness with choline and powerful B vitamins, both of which are essential in the production of the acetylcholine, the most abundant neurotransmitter in the body. Acetylcholine promotes concentration, good memory and healthy sleep patterns.

New sugar-free Winrgy® is the perfect vitamin and mineral supplement for people with active lifestyles as its essential ingredients help the body convert energy from carbohydrates, protein and fat. Unlike most canned energy drinks, new sugar-free Winrgy® comes in easy-to-use packets, a perfect fit in pockets and purses for on the spot get-up-and-go.

Part of the Physicians’ Health & Diet® Program, consumers say that the new sugar-free Winrgy® tastes great! Since it’s sweetened with Xylitol, it’s both healthier and better tasting than all the other sugar-free energy drinks available.

To see the new sugar-free Winrgy® video-advertisement, click here.

Read more: How does new, sugar-free, Winrgy® compare? Click here for more information.