FDA Warns About Lipodissolve Product Claims

It's a tempting premise: Get a series of drug injections and see pockets of fat on your body go away for good.

But the Food and Drug Administration (FDA) is alerting consumers about false and misleading claims being made about products used in lipodissolve, and about other misbranding of these products.

Recipients of lipodissolve get a series of drug injections intended to dissolve and permanently remove small pockets of fat from various parts of the body. The process is also known as injection lipolysis, lipozap, lipotherapy, and mesotherapy.

“We are concerned that these companies are misleading consumers,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by FDA for fat removal.”

The drugs most regularly used in the lipodissolve injection regimen are phosphatidylcholine and deoxycholate (commonly called PC and DC, respectively). Other ingredients may also be used, including drugs or components of other products such as vitamins, minerals, and herbal extracts.

What Consumers Should Know

FDA is alerting consumers that

it has not evaluated or approved products for use in lipodissolve
it is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination
the safety of these substances, when used alone or in combination, is unknown
it is not aware of clinical studies to support medical uses of lipodissolve

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include

permanent scarring
skin deformation
deep, painful knots under the skin in areas where the lipodissolve treatments were injected
FDA Actions

On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products. (Cyber letters are letters sent to companies whose U.S. online sales of products may be illegal.)

The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve

are safe and effective
have an outstanding safety record
are superior to other fat-loss procedures, including liposuction
Additionally some of the letters indicate that the companies have made claims that lipodissolve can be used to treatcertain medical conditions, such as male breast enlargement, benign fatty growths known as lipomas, excess fat deposits and surgical deformities.

The U.S. companies receiving warning letters in regard to lipodissolve products are

Monarch Med Spa, King of Prussia, Pa.
Spa 35, Boise, Idaho
Medical Cosmetic Enhancements, Chevy Chase, Md.
Innovative Directions in Health, Edina, Minn.
PURE Med Spa, Boca Raton, Fla.
All About You Med Spa, Madison, Ind.
FDA is requesting a written response from these U.S. companies within 15 business days of receipt of the letters stating how they will correct these violations and prevent similar violations in the future. These firms were told that failure to promptly correct the violations may result in legal action.

The Brazilian firm getting a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com. FDA will notify regulatory authorities in Brazil of this action. The agency has issued an import alert against the zipmed.net and mesoone.com entities to prevent the importation and distribution of unapproved lipodissolve drug products into the United States. Importing and distributing unapproved drug products is a violation of the Federal Food, Drug, and Cosmetic Act.

How to Report Side Effects
Consumers and health care professionals may report serious side effects with the use of lipodissolve products to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm4
by regular mail: Use postage-paid, pre-addressed FDA form 35005
by Fax: (800) FDA-0178
by phone: (800) FDA-1088
This article appears on FDA's Consumer Updates page6, which features the latest on all FDA-regulated products.

Vitamin B12 Deficiency: The Five Warning Signs

Author: Edward Sample

Vitamin B12, or cobalamin, is an essential building block of DNA and is key to the maintenance of our body's genes. In this role, it is an important element in ensuring the proper function of the nervous system and maintaining a healthy hematological profile.

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A proper diet and good nutrition is almost always sufficient to prevent B12 deficiency. The vitamin is naturally found in high protein foods such as meat, eggs, fish and dairy. In addition, those who regularly take a multivitamin are not likely to need extra vitamin B12 supplementation. However, ensuring enough B12 is ingested is important given that the body does not easily store the vitamin.

There is a high incidence of B12 deficiency in a few select groups. First, vegetarians or vegans who completely avoid animal based foods are at risk. Children who follow strict vegetarian diets absent of dairy products are particularly susceptible to low levels of the vitamin. Also, it is estimated that a high percentage of the elderly have some level of B12 deficiency.

This is because as we age, our ability to extract and absorb B12 from food-based protein sources diminishes. Also, seniors are more likely to have digestive problems, a degraded stomach lining, or have gone through some form of gastro-intestinal surgery. This contributes to the possibility of deficiency among this population.

Finally, large amounts of alcohol and caffeine have been shown to decrease the ability of the body to absorb the vitamin.It is important to recognize the 5 warning signs of B12 deficiency.

1. Stomach pain or digestive issues
2. Fatigue and weakness
3. Loss of sensation or tingling in lower extremities
4. Impaired cognitive function or dementia
5. Depression, irritability or moodinessStomach pain may be a symptom of pernicious anaemia, a condition where the immune system hinders the process by which the digestive system is able to absorb B12.

This results in the premature death of red blood cells. The fatigue and weakness that often accompanies low levels of the vitamin are also caused by anaemia.Given the importance of B12 to neurological function, a deficiency may result in several brain function issues such as the last three warning signs mentioned above.

Given a predisposition to B12 deficiency in those over 50, the loss of cognitive function, moodiness and irritability is often blamed on age as opposed to not getting enough of the vitamin. This is compounded by the fact that impaired mental function and dementia are often symptoms of Alzheimer's disease. Therefore, something as simple as a dietary gap is often overlooked as a cause of mental degradation. This is where supplementation with B12 can result in significant improvements.

Also, it is important to note that the effects of B6 and Folic Acid in coordination with B12 are collectively more powerful than just B12 alone. This is because the systems dependent on B12 also rely on these other substances for proper function. B12, along with Folic Acid and B6 are necessary to keep homocysteine in the blood down to healthy levels. Several studies have shown that increased levels of homocysteine are associated with greater incidence of heart disease and stroke.

These vitamins can reduce the risk of cardiovascular issues in that they convert homocysteine to methionine, an amino acid that is used in a productive manner by cells. In two other studies, vitamin B12 and folic acid were also shown to have a role in reducing the number of abnormal, pre-cancerous bronchial cells in heavy smokers. The primary form of B12 used as a nutritional supplement is cyanocobalamin. However, it is important to note that the absorption of B12 is much higher when the source is food based as opposed to via supplementation. While for extreme cases of deficiency, vitamin B12 is available via prescription as an injection or nasal gel, most supplementation is as part of a multivitamin, delivered as a pill, sublingual tablet, or lozenge.

The Recommended Daily Intake of B12 is 6 micrograms (mcg), even though supplements will often deliver as much as 30 mcg. Despite the wide range of dosage options, most healthy adults only need 3 mcg each day. Additionally, B12 taken orally is well tolerated by most and there have been no documented cases of overdose or toxicity associated with the supplement. While occurring infrequently, the side effects of B12 include rash, hives and itching.

Those who take any of the following medications may be at risk for B12 deficiency in that they have been shown to hinder absorption: Antibiotics, Proton Pump Inhibitors Cholestyramine, H2 blockers, Metformin, and Potassium Chloride. Calcium supplementation may also assist the body in its ability to absorb B12.

If you feel that you may be at risk of vitamin b12 deficiency, or are exhibiting any warning signs, go see your doctor immediately for more information. Aside from those with extreme medical conditions, the rest of us can easily ensure that we are getting enough of the nutrients essential to health by taking a well-formulated multivitamin.

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Article Source: http://www.articlesbase.com/medicine-articles/vitamin-b12-deficiency-5-warning-signs-103163.html