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Today, I'm going to tell you about a voluntary FDA recall on a popular Weight Loss Supplement and about weight loss supplements alleged to contain "Sibutramine," that was not listed on the product label.

I"ve been seeing "recalls" all over the internet, involving "Romaine Lettuce" and "Eggs" containing Salmonella.

Now.....I'm seeing articles from around the world reporting DEATHS from the use of "Weight Loss" Supplements containing "Sibutramine," that wasn't listed on the product label.

"Lyn By Pim" Dietary Weight Loss Supplements may contain Sibutramine and found to be linked to four deaths in Thailand.

A 31 year old woman in Thailand alledgedly took the supplements for 30 days and died on March 28. The medical examiner’s preliminary ruling was that she died of acute heart failure.

A 33 year old Bangkok man who allegedly had taken the supplements for 10 days died on April 6 after suffering a stroke and losing consciousness.

In another case, a 48 year old Pathum Thani man who allegedly had taken the supplements for more than a month died on April 27, with preliminary tests indicating acute heart failure.

The fourth person was said in social media posts to have died on April 28 after taking the same supplements..

"Lyn by Pim" Supplement weight loss tablets are sold in 10 tablet packages.

The “Black Box” is said to contain “Bisacodyl” a Laxative, which was not properly labeled on the product and the 10 tablet “white box” is said to contain the appetite suppressant “Sibutramine,” which was not properly labeled on the product.

 The Food and Drug Administration (FDA) ordered that production of Sibutramine be discontinued in October 2010. 

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Here is the "Safety Announcement" I pulled directly off of the FDA website:

FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)

Safety Announcement 

[10-8-2010] The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of Meridia (sibutramine) because this drug may pose unnecessary cardiovascular risks to patients. FDA has requested that Abbott Laboratories—the manufacturer of Meridia—voluntarily withdraw this drug product from the United States market. Abbott has agreed to voluntarily stop marketing of Meridia in the United States.

Meridia was FDA-approved in November 1997 for weight loss and maintenance of weight loss in patients with a body mass index (BMI) greater than or equal to 30 (≥30) kg/m2 or for patients with a BMI ≥27 kg/m2 who have other cardiovascular risk factors. BMI is a measure of body fat in adults that is based on height and weight. Patients with a BMI ≥30 kg/m2 are considered obese.

FDA’s recommendation is based on new data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated a 16% increase in risk of major adverse cardiovascular events (a composite of non-fatal heart attack, non-fatal stroke, resuscitation after cardiac arrest and cardiovascular death) in patients treated with Meridia compared to patients taking a placebo.

At the end of the trial (60 months), patients in the Meridia group lost a small amount of body weight compared to patients in the placebo group. FDA has concluded that the risk for an adverse cardiovascular event from Meridia in the population studied outweighed any benefit from the modest weight loss observed with the drug.

That was in 2010 people! 

Now.....Sibutramine is surfacting again! All over the internet.....for sale in Supplements and "Weight Loss Products."

I just went on “EBay” and found these same “Lyn by Pim” products being sold online.

*** USE CAUTION *** Nation!

Buying vitamins and weight loss supplements on line can be dangerous!

You have to know where the product is being manufactured......and.....what ingredients are "IN" the product.

If a product does not list where the supplement or vitamin is manufactured on the label.....DON'T BUY IT!

Transparency is key!

The FDA regulates legal and illegal drugs in the U.S. Vitamins and supplements are NOT regulated by the FDA. They do not have the man power to do it

Here are FAQ from the FDA website:

What is sibutramine and what are the associated risks?

Sibutramine is a Schedule IV controlled substance and the active pharmaceutical ingredient in Meridia, an approved prescription drug to treat obesity.

Populations who would be at increased risk of serious adverse health effects from consuming a standard dose of sibutramine include:

• Patients with a history of hypertension, especially those with uncontrolled or poorly controlled hypertension.
• Patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
• Patients with narrow angle glaucoma.
• Patients with a history of seizure.
• Patients predisposed to bleeding events and those taking concomitant medications known to affect hemostasis or platelet function.
• Patients with severe hepatic dysfunction.
• Patients concurrently taking the following medications:
  • Sumatriptan
  • Dihydroergotamine
  • Dextromethorphan
  • Meperidine,
  • Pentazocine
  • Fentanyl
  • Lithium
  • Tryptophan
  • MAO inhibitors

What label statements are required on the containers and packages of dietary supplements?

Five statements are required:

1) the statement of identity (name of the dietary supplement),

2) the net quantity of contents statement (amount of the dietary supplement),

3) the nutrition labeling,

4) the ingredient list, and

5) the name and place of business of the manufacturer, packer, or distributor.

Do I need to specify the country of origin if my product, or the ingredients in my product, is not from the United States?

Yes. Unless excepted by law, the Tariff Act requires that every article of foreign origin (or its container) imported into the United States conspicuously indicate the English name of the country of origin of the article.

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The 2nd item of importance is the Voluntary Recall of "Kratom" Brand Supplements, due to the presence of "Salmonella."

Here we go again!

Salmonella in Romaine Lettuce.....Salmonella in Eggs....now we have Salmonella in Weight Loss Supplements.

NutriZone LLC. a company out of Houston, TX has voluntarily "Recalled" ALL of it's "Kratom" Brand Supplements due to the possible presence of Salmonella.

The dietary supplements are labeled and packaged as follows:

Cali Green Malay

Cali Maeng Da

Cali Thai

Nirvanio Bali

Nirvanio Green Malay

Nirvanio Maeng Da

Nirvanio Special Reserve

Pain Out Green Malay

Pain Out Maeng Da

Pain Out Thai

The FDA states the products were sold "Nationwide" and particulary in the following States:

(FL, CA, OK, GA, SC, PA, LA, WA, MS, MO, KY, AZ, CO, TX, NY, IL).

The following statement is listed on the FDA website regarding the voluntary recall:

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine sampling and testing by the FDA revealed the presence of Salmonella.

Consumers who have purchased the products listed above should discontinue use of the product and may return the unused portion to the place of purchase for a full refund.

Consumers with questions may contact NutriZone, LLC, at 1-800-936-7936, Monday through Friday, 9am-5pm Central Standard time.

 

Kudos to NutriZone for taking a "ProActive" approach to this issue, avoiding a nationwide epidemic of Salmonella!

Anyone may also go to the FDA "Med Watch" website to check out information about the "Kratom" Recall or to Report any symptoms or ill side effects from using the NutriZone products.

FDA.org/Mediwatch/Report.htm

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