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Fetched from Food and Drug Administration Press Releases

The FDA released a statement regarding safety concerns with Total Body Formula and Total Body Mega Formula, manufactured by Total Body Essential Nutrition:

The U.S. Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.

The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

Read the entire report for more information.

To their credit, Total Body Essential Nutrition has voluntarily recalled affected products, and appears convinced selenium is to blame. This warning appears on their websites totalbodyformula.com/ and totalbodyteam.com/:

IF YOU ARE TAKING TOTAL BODY FORMULA, LOT # 4016801, 4016802, 4024801, 4024802, 4031801, 4031802 or 4031803 PLEASE STOP TAKING IT NOW AND CONSULT YOUR PHYSICIAN. THERE IS EXCESSIVE SELENIUM IN THE PRODUCT THAT CAN CAUSE SERIOUS HEALTH PROBLEMS.

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photo credit: Gary Thomson

Fetched from Food and Drug Administration Consumer Updates

FDA has received at least 73 reports of adverse reactions, including at least one death, related to the use of denture cleansers. Problems have occurred with both proper and improper use of these products.

FDA is asking manufacturers of denture cleansers to include a warning in the label about persulfates, which are known to cause allergic reactions in some people. Persulfates are used in most denture cleansers as part of the cleaning and bleaching process. The agency is also recommending that manufacturers consider appropriate alternatives to persulfates.

An allergic reaction to persulfates may not occur after the first use or even until after many years of use. Symptoms of an allergic reaction may not appear for several minutes or even hours after actual use. Symptoms may include irritation, tissue damage, rash, hives, gum tenderness, breathing problems, and low blood pressure.

Other reactions may be due to misuse of denture cleansers. For example, some cleansers may list mouthwash as an ingredient, but consumers should never chew, swallow, or gargle with denture cleansers.

To reduce misuse of denture cleansers, FDA is also recommending that manufacturers improve the directions on the label. Labeling revisions are needed to make it clear that these products are meant to clean dentures in a container, not while still in the mouth. Some patients have gargled or swallowed denture cleansers, resulting in abdominal pain, vomiting, seizures, breathing problems, and low blood pressure. Dentures should be thoroughly rinsed with water before they are placed in the mouth.

For more information, read the rest of the story.

Fetched from Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.

Read more here: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01791.html

I was wondering why I haven’t seen any Ambien commercials lately. According to the FDA,

Generic drugs cost about 20% to 70% less than their brand name counterparts. The Congressional Budget Office has reported that generic drugs save consumers an estimated $8 billion to $10 billion a year.

Here’s a list of some of the generic drugs approved by the FDA so far this year:

• Alendronate Sodium Tablets (Fosamax)
  Used for: Treating and preventing types of osteoporosis
  Originally marketed as: Fosamax, by Merck & Co.
  Date approved: Feb. 6, 2008
• Carvedilol Tablets (Coreg)
  Used for: Treating hypertension and heart failure
  Originally marketed as: Coreg, by SmithKline Beecham, now GlaxoSmithKline
  Date approved: Sept. 5, 2007
• Cetirizine HCl Tablets (Zyrtec)
  Used for: Treating symptoms of allergies
  Originally marketed as: Zyrtec, by Pfizer
  Date approved: Dec.12, 2007
• Granisetron Tablets (Kytril)
  Used for: Preventing nausea and vomiting related to chemotherapy and radiation
  Originally marketed as: Kytril, by Roche
  Date approved: Dec. 31, 2007
• Oxcarbazepine Tablets (Trileptal)
  Used for: Treating certain kinds of seizures and epilepsy
  Originally marketed as: Trileptal, by Novartis
  Date approved: Oct. 9, 2007
• Pravastatin Sodium Tablets (Pravachol)
  Used for: Treating elevated cholesterol and preventing coronary events.
  Originally marketed as: Pravachol, by Bristol-Myers Squibb
  Date approved: Apr. 23, 2007
• Zolpidem Tartrate Tablets (Ambien)
  Used for: Treating insomnia
  Originally marketed as: Ambien, by Sanofi Aventis
  Date approved: Apr. 23, 2007

For more information, the FDA’s Office of Generic Drugs maintains a frequently-updated list of generic drug approvals.

Penny Arcade has a great strip today that sums up how I feel about consumer-targeted pharmaceutical advertising:

I especially like how drug ads are starting to use the verbage “Ask your doctor for a sample of Killzoudedia” - between the drug companies and the insurance companies, doctors are having less and less opportunity to actually diagnose their patients’ ailments.

This article at IOL about Australian artist Justine Cooper dovetails this topic nicely.  Justine invented a disease (Dysphoric Social Attention Consumption Deficit Anxiety Disorder, or DSACDAD) and a drug for its symptoms, Havidol.  According to the article:

But the multi-media exhibit at the Daneyal Mahmood Gallery in New York, which includes a website, mock television and print advertisements and billboards is so convincing people think it is authentic.

“People have walked into the gallery and thought it was real,” Mahmood said in an interview.

The Havidol website is a great read, especially the safety information including the following warnings:

In clinical trials, the most commonly reported side effects were mood changes, muscle strain, extraordinary thinking, dermal gloss, impulsivity induced consumption, excessive salivation, co-dependency with inanimate objects, hair growth, markedly delayed sexual climax, inter-species communication, taste perversion, terminal smile, and oral inflammation.

In rare instances, patients reported a sudden urge to change physicians. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden loss of interest in your physician let them know right away. Your doctor may need to make a change in the dose that is right for you.

Now that’s what I call truth in advertising.