Fucopure’s advertising claims forwarded to FTC
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Tuesday referred advertising published by Nutraceuticals International for Fucopure to the Federal Trade Commission for further review.
Nutraceuticals declined to participate in an NAD proceeding, following a challenge to its advertising by P.L. Thomas, a competing maker of dietary supplements.
NAD, the advertising industry’s self-regulatory forum, asked the advertiser to provide substantiation for disease claims that tout FucoPure as a “totally new, totally innovative approach to combating obesity, hyperlipidemia and Type II diabetes.”
Under Food and Drug Administration regulations, no dietary supplement can be purported to treat, mitigate or prevent a disease, which would include obesity, hyperlipidemia and diabetes.
NAD also requested substantiation for weight-loss claims that state FucoPure was proven in the “First U.S. human clinical trial to show the ability of a physician strength Fucoxanthin extract to significantly reduce body weight, percent body fat …” and strong superiority and exclusivity claims, including claims that state that FucoPure is “The Only Clinical Strength Fucoxanthin 10% Extract.”
The advertiser failed to respond to NAD’s initial inquiry, but responded through its attorney after receiving NAD’s second letter. At that time, the advertiser, through its attorney, requested an extension as a professional courtesy, which was granted. The advertiser failed to file a response on the agreed upon date, and despite continued outreach from NAD, has refused to participate.
Given the advertiser’s failure to provide a substantive response, pursuant to Section 2.9 of the NAD/NARB Procedures, NAD will refer this matter to the FTC and FDA for possible law enforcement action.
Pregnant women with gum disease at risk for gestational diabetes
NEW YORK A new study by New York University dental researchers released Saturday has uncovered evidence that pregnant women with periodontal (gum) disease face an increased risk of developing gestational diabetes, even if they don’t smoke or drink, a finding that underscores how important it is for all expectant mothers – even those without other risk factors – to maintain good oral health.
The study, led by Ananda Dasanayake, professor of Epidemiology and Health Promotion at New York University College of Dentistry, in collaboration with the Faculty of Dental Sciences at the University of Peradeniya, Sri Lanka, eliminated smoking and alcohol use among a group of 190 pregnant women in the South Asian island nation of Sri Lanka, where a combination of cultural taboos and poverty deter the majority of women from smoking and drinking. The findings support an earlier study led by Dasanayake that found evidence that pregnant women with periodontal disease are more likely to develop gestational diabetes than pregnant women with healthy gums.
That study, which followed 256 women at New York’s Bellevue Hospital Center through their first six months of pregnancy, showed that 22 of the women developed gestational diabetes. Those women had significantly higher levels of periodontal bacteria and inflammation than the other women in the study. The findings were published in the April 2008 issue of the Journal of Dental Research.
More than one-third of the women in the new study, which was conducted over the course of one year, reported having bleeding gums when they brushed their teeth. The women were given a dental examination and a glucose challenge test, which is used specifically to screen for gestational diabetes. According to Dasanayake, those women found to have the greatest amount of bleeding in their gums also had the highest levels of glucose in their blood. Dasanayake, who presented the findings Saturday at the annual meeting of the International Association for Dental Research in Miami, said that he expected the final data to show that between 20 and 30 of the women had developed gestational diabetes.
Gestational diabetes is characterized by an inability to transport glucose — the main source of fuel for the body — to the cells during pregnancy. The condition usually disappears when the pregnancy ends, but women who have had gestational diabetes are at a greater risk of developing the most common form of diabetes, known as Type 2 diabetes, later in life. Asians, Hispanics and Native Americans are at the highest risk for developing gestational diabetes. All of the women in the Sri Lanka study were of Asian origin, while 80% of the New York study subjects were Hispanic.
“In addition to its potential role in preterm delivery, evidence that gum disease may also contribute to gestational diabetes suggests that women should see a dentist if they plan to get pregnant, and after becoming pregnant,” Dasanayake said. “Treating gum disease during pregnancy has been shown to be safe and effective in improving women’s oral health and minimizing potential risks.”
Medical research finds link between bisphosphonates, irregular heartbeat
WINSTON-SALEM, N.C. New research at Wake Forest University School of Medicine released Monday evaluated the link between a common class of drugs used to prevent bone fractures in osteoporosis patients and the development of irregular heartbeat.
Researchers found that bisphosphonate use was associated with a significant increase in the incidence of “serious” heart rhythm disturbances, classified by hospitalization, disability or death resulting from the condition. However, when they included “non-serious” cases in their analysis, they found no overall increased risk of atrial fibrillation.
“Our findings were discordant, with conflicting results,” stated Sonal Singh, an assistant professor of internal medicine and lead investigator for the study. “The challenge now is to figure out what it all means.”
Early studies indicated that the use of bisphosphonates might cause problems with heart rhythm, or atrial fibrillation, which increases the risk for stroke or heart attack. For the study published this month, researchers analyzed the data from previous observational studies and clinical trials to determine the link between bisphosphonate therapy and irregular heart beat.
“Some trials show there could be a potential link between the use of bisphosphonates and the development of serious heart rhythm problems, but in our study the link wasn’t conclusive,” Singh said. “So we urge that additional investigations be conducted.”
Bisphosphonates, found in prescription drugs including Boniva (ibandronate sodium), Fosomax (alendronate), Reclast (zoledronic acid) and Actonel (risedronate sodium), inhibit the breakdown of bones, which reduces the risk of fractures, especially those of the spine and hips in older patients. The first such drugs were approved for use in the mid-1990s.
In the clinical trials reviewed, medical records of more than 13,000 patients who had osteoporosis or fractures and were given bisphosphonates were compared to the records of more than 13,000 patients who received a placebo during study participation. Researchers were looking for the incidence of irregular heartbeat first, and then stroke or death caused by stroke or heart attack as a secondary outcome. The patient files reviewed were primarily of women who were treated with bisphosphonates and were generally in their early 70s, according to the study.
“We found no risk of stroke and cardiovascular mortality in the trials,” Singh said. “That was very reassuring.”
Given these results, physicians should not change they way they prescribe the drugs for the majority of patients with osteoporosis, Singh said, and patients should not stop taking them. He cautioned, however, that patients with pre-existing heart conditions and those with risk factors for rhythm disturbance should be especially vigilant for the development of atrial fibrillation, and doctors should continue to closely monitor patients at risk for atrial fibrillation who are taking bisphosphonates.
The study’s findings appear in the current issue of Drug Safety, a publication of the International Society of Pharmacovigilance covering the safe and proper use of medicines.