June 2008 Archives

Total Body Formula Recall

June 10, 2008, by JONES WARD PLC

Here is the link to the company's website recalling lot numbers: 4016801, 4016802, 4024801, 4031801, 4031802 or 4031803.

According to Total Body Essential Nutrition, Inc.'s website:

WARNING PUBLIC NOTICE

IF YOU ARE TAKING TOTAL BODY FORMULA, LOT # 4016801, 4016802, 4024801, 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.

http://www.totalbodyteam.com/

Posted by Louisville, Kentucky lawyer: Larry Jones (larry@jonesward.com)

Total Body Formula and Total Body Mega Formula

June 10, 2008, by JONES WARD PLC

As referenced earlier, the FDA has warned consumers of serious adverse reactions associated with certain dietary supplements: Total Body Formula in Tropical Orange and Peach Nectar flavors, and Total Body Mega Formula in Orange/Tangerine flavor.

Total Body Essential Nutrition, Inc. of Atlanta, GA has voluntarily recalled certain lots of the liquid dietary supplement which has been found to contain hazardous levels of the minerals selenium and chromium. Samples tested by the FDA contained 40,800 micrograms per serving of selenium (up to 200 times the amount indicated on the label) and 3,426 micrograms per serving of chromium (up to 17 times the recommended intake). The human body requires selenium and chromium in small amounts, but ingestion of large amounts of these minerals or products containing them can be harmful. Adverse reactions generally occurred after 5-10 days of daily ingestion of the product.

The number of confirmed cases of adverse reactions in consumers using these products has climbed to over 200 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas and Virginia.

Injuries Associated With Selenium Toxicity are: Significant hair loss, Muscle cramps, Diarrhea, Joint Pain, Fatigue, Loss of finger nails and blistering skin.

Injuries Associated With Chromium Toxicity are: Renal failure, Liver toxicity, Thrombocytopenia, Changes in thought processes, Gastrointestinal disorders, Chest pain, Erythema/flushing/rash, Dizziness, Headache, Agitation, Rhabdomyolysis (rapid breakdown of muscle tissue), and Interference with certain medications

Total Body Formula products are sold in 8 oz. and 32 oz. plastic bottles; Total Body Mega Formula is sold in 32 oz. plastic bottles. The products were distributed to 16 states (Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia) and were also sold over the world wide web.

Total Body products with the following lot numbers have been recalled: Total Body Tropical Orange #4016801, 4024801, and 4031801; Total Body Peach Nectar #4016802 and 4031802; and Total Body Mega Orange/Tangerine #4031803.

Consumers are advised to consult their health care professional if they have experienced any adverse reactions. Consumers and health care professionals can also report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

Posted by Louisville, Kentucky lawyer: Larry Jones

Total Body Formula and Total Body Mega Formula Recall --Louisville, Ky. Courier Journal

June 10, 2008, by JONES WARD PLC

The US Food and Drug Administration has recalled of Total Body Formula in tropical and peach nector flavors and Total Body Mega Formula in the orange/tangerine flavor. Following the FDA recall, Kentucky officials issued a health advisory on April 9, 2008 warning that these dietary supplements may cause serious health problems, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

The FDA analyzed samples of the Total Body products and found extremely high levels of the trace mineral selenium. Kentucky officials have correctly advised individuals to seek medical attention if they become sick after the use of the product. However, Kentucky officials have mistakenly instructed individuals to dispose of the product. Instead, these individuals should secure the product for their legal team to pursue their claims against the makers of Total Body Formula and Total Body Mega Formula.

For more information, see http://www.courier-journal.com/apps/pbcs.dll/article?AID=/20080410/NEWS01/804100436/1008/NEWS01

Posted by Louisville, Kentucky lawyer: Larry Jones

FDA MedWatch- Remicade, Enbrel, Humira and Cimzia- FDA Investigating Tumor Necrosis Factor Blockers And Cancer Risk In Children And Young Adults

June 4, 2008, by JONES WARD PLC

From the FDA:

FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About n Ongoing Safety Review of Tumor Necrosis Factor (TFF) Blockers regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF

Posted by Louisville, Kentucky lawyer: Larry Jones

Digitek Prescription Drug Class Action Filed

June 2, 2008, by JONES WARD PLC

A Digitek class action lawsuit has been filed in US District Court in New Jersey against the Icelandic prescription drug maker, Actavis Group. Actavis recalled Digitek, its generic version of the prescription drug digoxin, two weeks ago because some batches of the medicine may have contained tablets that were twice the normal thickness and strength. The plaintiffs in the Digitek prescription drug lawsuit are seeking compensation for their injuries, as well as the costs of medical monitoring in case they experience future health problems. In addition to Actavis, the Digitek prescription drug lawsuit also names Mylan Pharmaceuticals Inc. and UDL Laboratories, which distributed the prescrption medication, as defendants. More

Posted by Louisville, Kentucky lawyer: Larry Jones

Study: PAGCL linked to Pain Pump Usage

June 1, 2008, by JONES WARD PLC

Here is the American Journal of Sports Medicine article about the study which linked the use of pain pumps to Postarthroscopic Glenuhumeral Chondrolysis (PAGCL). Click here.

Posted by Louisville, Kentucky lawyer: Larry Jones (larry@jonesward) 1-888-KYLAW22