Tuesday, June 1, 2010

Drug Adverse Effect News: SSRI Use Linked to Miscarriage

This study adds to the rapidly accumulating pile of evidence that raises doubts about the safety and efficacy of selective serotonin reuptake inhibitors (SSRIs).

Antidepressants in Pregnancy Increase Risk of Miscarriage, Study Finds

ScienceDaily (May 31, 2010) — A new study in CMAJ (Canadian Medical Association Journal) found a 68% increase in the overall risk of miscarriage in pregnant women using antidepressants.

Antidepressants are widely used in pregnancy and up to 3.7% of women will use them at some point during the first trimester. Discontinuing treatment can result in a depressive relapse which can put mother and baby at risk.

Most previous studies on the use of antidepressants in pregnancy did not look at miscarriages as a main outcome, had small samples and several showed contradictory results. This large study sought to determine the association between antidepressant use in pregnancy, including classes, types and doses, and the risk of miscarriage.

Researchers from the University of Montreal and the CHU Ste-Justine looked at data on 5124 women in Quebec from a large population-based cohort of pregnant women who had clinically verified miscarriages up to 20 weeks of gestation and a large sample of women from the same Registry who did not have a miscarriage. Of those who miscarried, 284 (5.5%) had taken antidepressants during pregnancy.

Selective serotonin reuptake inhibitors (SSRIs), especially paroxetine and also venlafaxine were associated with increased risk of miscarriage as were higher daily doses of either antidepressant. As well, a combination of different antidepressants doubled the risk of miscarriages.

"These results, which suggest an overall class effect of selective serotonin reuptake inhibitors, are highly robust given the large number of users studied," writes senior author Dr. Anick Bérard, from the University of Montreal and the Director of the Research Unit on Medications and Pregnancy at CHU Ste-Justine.

The researchers urge that physicians who have patients of child-bearing age taking antidepressants or have pregnant patients who require antidepressant therapy early in pregnancy discuss the risks and benefits with them.

In a related commentary Ms. Adrienne Einarson, Assistant Director of the Motherisk Program at The Hospital for Sick Children (SickKids) writes that there is no "gold standard for studying the safety of drugs during pregnancy, because all methods have strengths and limitations," and results can vary from one study to the next. In this study, there were missing data on important potential confounding factors. However, the overall results on the use of antidepressants during pregnancy and the risk of miscarriage, despite the different methodology, were almost identical to a Motherisk study with 937 women published in 2009.

"Clearly, this study cannot make any definitive conclusions as to whether antidepressants increase the risk of spontaneous abortion," although the author points out it appears there is a small risk with less than double the number of miscarriages in the women exposed to antidepressants compared to those not exposed.

Legislative News: Health Retailer Sting Detailed in US. Senate

This sort of 'sting' operation has been done many times before. It's meant to tarnish health retailers and the products they sell. If the same sort of thing was done with say, conventional physicians, how would the quality of their advice stack up against that offered by retailers?

Supplements on Senate Hearing Hot Seat

The Special Senate Committee on Aging held a hearing this week on dietary supplement regulation, safety and quality control. The panel of Senators included Herb Kohl (D-Wis.), Orrin Hatch (R-Utah), Al Franken (D-Minn.) and Bob Corker (R-Tenn.), and featured witnesses from the Government Accounting Office (GAO), Consumer Union (CU, publishers of Consumer Reports), Consumerlab.com and the Council for Responsible Nutrition (CRN).

A ton of details pertaining directly to supplement manufacturers was presented and discussed (read this, this and this for a more detailed look), but retailers were not absolved of marketing and selling allegations. At the behest of Sen. Kohl, GAO investigated areas of supplement marketing, including their sending undercover “senior consumers” into various retail locations in DC and Florida. In the hearing they reported, along with recorded examples, cases in which retail staff gave the fake consumers misleading advice—one suggested a supplement could replace prescribed meds—and using illegal claims. There was much discussion between the Senators and the witnesses about how to better educate retailers and their staff to limit these types of communications. There were no easy, magical solutions, but it appeared the consensus was for a united effort by trade organization, retail management and government to make sure retail staffers aren’t misleading consumers and/or breaking the law.

How do you train your staff on such matters, and what kind of assistance from industry and government would help you in this task?

Source: Natural Products Marketplace

Ingredient News: Olive Leaf Extract for Skeletal Health

Oleuropein- rich olive leaf extract is commonly employed to treat an overgrowth of gut-based bacterial or fungal pathogens. This study shows that oleuropein upregulates osteoblast differentiation which is necessary for humans to make new bone.

Olive Leaf Compound Nips Bone Loss

CORDOBA, Spain—Oleuropein, a polyphenolic compound found in olive leaf and other olive products, may help slow age-related bone loss and osteoporosis, according to recent research published online May 21, 2010 in Osteporosis International journal. The researchers from the Hospital Universitario Reina Sofia studied the effects of oleuropein on osteoblastogenesis and adipogenesis in mesenchymal stem cells (MSCs) from human bone marrow.

They noted bone loss is associated with insufficient osteoblast function (bone building), which is associated with with adipogenesis (conversion of pre-fat cells into fat cells); age-related alterations to this process can lead to fatty bone marrow, a marker of osteoporosis. They further reported oleuropein is known to reduce the expression of peroxisome proliferator-activated receptor gamma (PPARγ), inhibit adipocyte differentiation, and improve differentiation into osteoblast.

Their in vitro study ofoleuropein in MSCs showed an increase in osteoblast differentiation and a decrease in adipocyte differentiation when there is oleuropein in the cultured media. Also, various osteoblastogenesis markers were higher in oleuropein-treated MSCs, as were ALP activity and extracellular matrix mineralization. The olive polyphenol also appeared to affect the expression of genes involved in adipogenesis. The researchers concluded, "Our data suggest that oleuropein, highly abundant in olive tree products included in the traditional Mediterranean diet, could prevent age-related bone loss and osteoporosis."

Regulatory News: Health Canada Raids BC Health Retailer

Recently, Health Canada has focused its NHP enforcement efforts on border control and at the manufacturer or supplier level. Are we facing a return to the 'bad old days' when health retailers were routinely raided for stocking carnitine? Was this raid motivated by complaints from consumers who experienced adverse effects from the seized products? Or, was this just the result of predatory trolling by government bureaucrats?

Unauthorized Health Products Seized at YVS (Your Vitamin Store) in Burnaby, B.C.

Advisory
2010-84
May 26, 2010
For immediate release

The issue

Unauthorized health products that may pose a serious health risk were seized by Health Canada at YVS (Your Vitamin Store) in Metrotown, Burnaby, British Columbia. The labels indicate the products contain ingredients that legally require the products to be sold by prescription or with specific controls because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner.

Who is affected

Canadians who have purchased DHEA, Free Form Carnitine, Acetyl-L-Carnitine, Hydro Lean, Xtra Lean, Yohimbe Extract, Hemo Rage Black, Lipo 6 Black, Lipo 6 Hers Black or Red Rockets sold at the YVS (Your Vitamin Store) in Metrotown, Burnaby, including over the Internet.

What consumers should do

  • Consult your healthcare practitioner if you have used any of these products and are concerned about your health.
  • Read the labelling of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.
  • Report any adverse reaction potentially related to these products to Health Canada (see below).
What Health Canada is Doing

Health Canada is working with the Canada Border Services Agency to help stop the future importation of these unauthorized health products into Canada. Health Canada has been advised that these unauthorized products will no longer be sold from the YVS (Your Vitamin Store) in Metrotown, Burnaby.

Background

These products contain ingredients that can cause serious health problems. Ephedrine and caffeine, when combined together, may cause serious and possibly fatal adverse effects. Canadians suffering from heart conditions, high blood pressure and diabetes are among those particularly at risk. Side-effects associated with L-Carnitine include nausea, vomiting, abdominal

cramps, diarrhea and seizures. Side-effects associated with yohimbine include anxiety and increased urinary frequency, dizziness, stomach problems, headache, sweating, sleeplessness, tremors, palpitations of the heart and severe high blood pressure.

Canadians who have taken products containing these ingredients without the supervision of a health care practitioner or without a prescription may face additional risks. You may be misdiagnosed, the treatment might not be appropriate to treat your illness and you may miss the opportunity to obtain appropriate medical treatment. You may also put yourself at risk for drug interactions, or harmful side effects.

Regulations administered by Health Canada require that health products containing certain medicinal ingredients be subject to specific controls and/or be prescribed by a health care practitioner because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner.

Specific drug ingredients may be subject to additional restrictions as outlined in the Food and Drugs Act and the Controlled Drugs and Substances Act. This may include the need for a prescription from a health care practitioner, the application of specific controls to allow for professional direction and supervision in their use, or the application of additional controls on the sale and storage of the product.

Products affected

  1. Hemo Rage Black manufactured by Nutrex, contains Yohimbine HCl.
  2. Lipo 6 Black (UPC label 853237001230) manufactured by Nutrex Research, contains 11-hydroxy-yohimbine, alpha yohimbine, yohimbine HCl (4.5mg).
  3. Lipo 6 Hers Black (UPC Label 853237001261) manufactured by Nutrex Research, contains 11-hydroxy-yohimbine, alpha yohimbine, yohimbine HCl (4.5mg).
  4. Yohimbe Extract (UPC label 833343000167) manufactured by West Pharm, contains Yohimbe (Standardized for 9mg Yohimbine).
  5. Free form Carnitine manufactured by Bio Advanced, contains L-Carnitine.
  6. Acetyl-L-Carnitine manufactured by Bio Advanced, contains Acetyl-L-Carnitine.
  7. DHEA (UPC label 622615103237), manufactured by Bio Advanced, contains Dehydroepiandrosterone.
  8. Red Rockets (UPC label 624340042652) manufactured by Integrity Labs, contains Ephedra (8% Ephedrine) and Kola-nut (standardized 75% caffeine).
  9. Hydro Lean (UPC label 833343000020) manufactured by West Pharm, contains L-Carnitine, MaHuang Extract (Standardized to 8% Ephedrine) and Guarana Extract (standardized 22% caffeine).
  10. Xtra Lean (UPC label 833343000013) manufactured by West Pharm, contains Acetyl L-Carnitine, Deanol, MaHuang (Standardized to 20 mg Ephedrine) and Guarana Extract (standardized 200 mg caffeine).
For more information

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

Legal News: FDA Loses Important Court Battle Over Selenium Claims

Everything about this case is important. The plaintiffs are veteran 'health freedom' advocates. Their lawyer, Jonathan Emord has been a formidable thorn in the FDAs side for years. The principle decided bythe court effectivelyundermines the ability of the FDA to unilaterally restrict and censor claims made by supplement manufacturers. If this court ruling stands and many U.S. health products are sold with label and advertising claims, there will be pressure on Health Canada to follow suit.

US Court Rules in Favour of Free Speech on Health Claims

DORKING, UK: The US Food and Drug Administration (FDA) lost its bid to overturn a health claim for selenium-containing dietary supplements last Thursday in the United States District Court for the District of Columbia. District Court Judge Ellen Huvelle ruled unconstitutional the FDA’s censorship of selenium dietary supplement claims relating to the reduction of cancer risk. Jonathan Emord of Emord & Associates on behalf of the plaintiffs in the case (including lead plaintiff Alliance for Natural Health USA (ANH-USA); Durk Pearson and Sandy Shaw; and the Coalition to End FDA and FTC Censorship). The verdict, unless reversed on appeal, protects the First Amendment right of dietary supplement manufacturers to provide “qualified health claims”, which accurately communicate the state of science concerning dietary supplements. This is a remarkable seventh victory over the FDA by the Emord firm (six of which invalidated FDA health claim censorship).

The lawsuit was initiated last summer in response to the FDA’s 19th June 2009 decision to suppress selenium/cancer-risk reduction claims. Ten of the claims (all appealed by the plaintiffs) were held unconstitutionally censored. The plaintiffs expressed their belief that this violated their right to communicate truthful health information to the public. The judge found that the FDA had denied claims despite credible evidence supporting them and had thereby infringed on free speech.

Prior to this ruling the FDA required near conclusive scientific evidence for any nutrient claim. The judge ruled that so long as the claim is an accurate reflection of the state of science, the First Amendment protects it.

For more information:


INDUSTRY NEW: Whole Foods Market® Kicks Off 30th Birthday Celebration by Inviting Shoppers to Share the Love

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Whole Foods Market® Kicks Off 30th Birthday Celebration by Inviting Shoppers to Share the Love: "

AUSTIN, Texas (June 1, 2010) – To acknowledge the long-term support and tremendous loyalty of its customers, Whole Foods Market invites shoppers to enter its “A Heart as Big as Texas” short essay contest for a chance to win a culinary celebration weekend in its hometown headquarters of Austin, Texas. The contest kicks off a series of the Company’s “30 Years Fresh” birthday festivities held at all 298 stores in Canada, the United Kingdom and the United States.


To enter, participants can visit wholefoodsmarket.com/birthday to share their special stories, inspirations and memories about Whole Foods Market. Entries will be judged on their originality, creativity and passion and must be received by June 30, 2010.


Thirty winners will be chosen to each receive an all-expense paid trip for two to the birthplace of Whole Foods Market where they will be treated to a VIP culinary weekend. Helping Whole Foods Market bring “A Heart as Big as Texas” to life are Texas Tourism, the state’s marketing entity which promotes the Lone Star State’s seven diverse regions, bold experiences and flavors to travelers nation- and worldwide; JetBlue Airways, which will offset the travel emissions from the 60 flights awarded in the contest through donations to its carbon-offset partner Carbonfund.org; and Radisson Austin, which offers upscale accommodations on Lady Bird Lake, just blocks away from Austin’s entertainment district and from Whole Foods Market’s landmark store and global headquarters.


“From the moment our original 19 team members opened our first store in Austin 30 years ago, we have appreciated the support from our shoppers who have truly been the secret to our success. By highlighting their favorite stories, we’d like to pay tribute to our customers from all over and thank them for three decades together,” said Walter Robb, co-CEO of Whole Foods Market.


Whole Foods Market officially turns 30 on Monday, September 20. From September 17-20, Whole Foods Market stores all over will host birthday celebrations open to the public. Dates and times for the festivities will be posted on each store’s website by July 1.


For more information, go to wholefoodsmarket.com/birthday. For Twitter news and updates:


http://twitter.com/WholeFoods, #WholeFoods30


http://twitter.com/TexasTourism


http://twitter.com/jetblue


http://twitter.com/RadissonTwnLake.

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INDUSTRY NEWS: Whole Foods Market® Kicks Off 30th Birthday Celebration by Inviting Shoppers to Share the Love

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AUSTIN,
Texas (June 1, 2010) – To acknowledge the long-term support and tremendous loyalty of its customers, Whole Foods Market invites shoppers to enter its “A Heart as Big as Texas” short essay contest for a chance to win a culinary celebration weekend in its hometown headquarters of Austin, Texas. The contest kicks off a series of the Company’s “30 Years Fresh” birthday festivities held at all 298 stores in Canada, the United Kingdom and the United States.

To enter, participants can visit wholefoodsmarket.com/birthday to share their special stories, inspirations and memories about Whole Foods Market. Entries will be judged on their originality, creativity and passion and must be received by June 30, 2010.

Thirty winners will be chosen to each receive an all-expense paid trip for two to the birthplace of Whole Foods Market where they will be treated to a VIP culinary weekend. Helping Whole Foods Market bring “A Heart as Big as Texas” to life are Texas Tourism, the state’s marketing entity which promotes the Lone Star State’s seven diverse regions, bold experiences and flavors to travelers nation- and worldwide; JetBlue Airways, which will offset the travel emissions from the 60 flights awarded in the contest through donations to its carbon-offset partner Carbonfund.org; and Radisson Austin, which offers upscale accommodations on Lady Bird Lake, just blocks away from Austin’s entertainment district and from Whole Foods Market’s landmark store and global headquarters.

“From the moment our original 19 team members opened our first store in Austin 30 years ago, we have appreciated the support from our shoppers who have truly been the secret to our success. By highlighting their favorite stories, we’d like to pay tribute to our customers from all over and thank them for three decades together,” said Walter Robb, co-CEO of Whole Foods Market.

Whole Foods Market officially turns 30 on Monday, September 20. From September 17-20, Whole Foods Market stores all over will host birthday celebrations open to the public. Dates and times for the festivities will be posted on each store’s website by July 1.

For more information, go to wholefoodsmarket.com/birthday. For Twitter news and updates:
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