Byetta (exenatide) is a subcutaneous injection given twice a day to persons with Type-2 diabetes to lower their blood sugar levels. Since it was approved in the United States in April 2005, it has been used by about 1 million people.

Although sales of the drug grew 17 percent in the second quarter this year as compared to the same period last year, concerns have grown recently among users and prescribers about a possible Byetta side effect which could increase the risk of pancreatitis.

On August 18, 2008, the FDA posted an alert on their website to notify doctors that the agency had received reports of at least six cases of necrotizing pancreatitis or hemorrhagic pancreatitis associated with Byetta. The FDA indicated that two of those six had died as a result of the severe cases of acute pancreatitis, and the other four were recovering.

Following the close of the U.S. markets on Monday, Eli Lilly and Amylin, who jointly market Byetta, held a conference call for the media, investors and the general public to discuss the possible association between Byetta and pancreatitis. At that time, the drug makers indicated that they had also notified the FDA of at least four other pancreatitis deaths among users of Byetta. However, they suggested that they do not believe there is any definite relationship between the drug and the deaths.

Eli Lilly and Amylin are in talks with the FDA about the possibility of new warnings about the Byetta pancreatitis risks. There are indications from some financial analysts that Byetta could receive a “black box” warning, which is the strongest warning issued by the FDA. The company did not disclose details regarding when the label change could take effect.

If a “black box” warning about pancreatitis is placed prominently on the Byetta label, it will likely cause a substantial drop in sales for Byetta, which is a big seller for the manufacturers. It could also reduce the chances that the FDA will approve a newer, longer acting version of the drug which is only injected once a week.

The drug makers will also likely face an increasing number of Byetta lawsuits from users who suffer pancreatitis after taking the drug.

The first known Byetta pancreatitis lawsuit has already been filed in California state court, coming only a few days after the FDA’s alert last week.

On March 27, 2008, the FDA issued the first of three warnings about the dietary supplement, asking consumers to stop using Total Body Formula in peach nectar and tropical orange flavors, as well as Total Body Mega Formula in tangerine/orange flavor.

High levels of selenium (more than 200 times the label value) and chromium (up to 17 times the label value) were found in these products, which could cause serious and potentially fatal injuries.

Following the Total Body Formula recall, the CDC and FDA have reported a number of serious side effects associated with the defective dietary supplements, including kidney failure, rhabdomyolysis, gastrointestinal disorders, hemolysis, thrommbocytoenia and increased hepatic enzymes. Symptoms of problems associated with Total Body Formula side effects could include hair loss, finger nail loss, chest pain, flushing, dizziness, rash and headaches.

A number of Total Body Formula lawsuits have been filed throughout the United States by individuals who experienced problems after using the dietary supplement. The petition seeks to consolidate and centralize all of the federal lawsuits in one court for pretrial litigation, under a federal procedure known as Multidistrict Litigation, or MDL.

According to the Notice of Hearing Session issued by the Judicial Panel on Multidistrict Litigation, at least 15 lawsuits have been filed against Total Body Essential Nutrition, Inc., and other defendants. Most of the lawsuits have been filed in  the Northern District of Alabama, but cases are also pending in the Middle District of Florida and the Northern District of Florida.

If the cases are consolidated and centralized after the September 25, 2008 hearing, every pending Total Body Formula lawsuit pending in a federal court in the United States will be transferred to one jurisdiction, where they will be assigned to a single judge to oversee. Through the Multidistrict Litigation procedure, complex cases involving common questions of fact can be consolidated to avoid duplication of discovery, inconsistent pretrial rulings and inconvenience to the parties and witnesses.

The defective “Total Body Formula” products were sold in eight-ounce plastic bottles and the “Total Body Mega Formula” products in 32-ounce plastic bottles. The Total Body recall applies to the following products:

• Total Body Tropical Orange — Lot nos. 4016801, 4024801 and 4031801
• Total Body Peach Nectar — Lot nos. 4016802 and 4031802
• Total Body Mega Orange/Tangerine — Lot no. 4031803

TOTAL BODY FORMULA LAWSUIT STATUS: A number of lawsuits have been filed by users who suffered serious injuries as a result of the Total Body Formula problems. A petition has been filed to consolidate all federal Total Body Formula lawsuits in one jurisdiction, and hearings will be held September 25, 2008 to consider this motion.

>>REVIEW A TOTAL BODY FORMULA LAWSUIT WITH A LAWYER<<

MANUFACTURER: Total Body Essential Nutrition, Inc.

TOTAL BODY FORMULA RECALL: On March 28, 2008, the FDA notified 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. Two additional health alerts have been issued about this supplement and the danger it poses to the public.

The recall applied to the following products:

• Total Body Tropical Orange — Lot nos. 4016801, 4024801 and 4031801
• Total Body Peach Nectar — Lot nos. 4016802 and 4031802
• Total Body Mega Orange/Tangerine — Lot no. 4031803

Hazardous levels of selenium (which were more than 200 times the appropriate amount) and chromium (which were more than 17 times the appropriate amount) were found in samples.

TOTAL BODY FORULA PROBLEMS: The FDA and CDC received a number of reports from over 200 users in multiple states who suffered severe and life threatening injuries after daily use of the liquid dietary supplement. Side effects of Total Body Formula could include:

• Fatigue and Joint Pain
• Muscle Cramps and Diarrhea
• Significant Hair Loss
• Deformed Fingernails
• Hypoglycemia
• Renal Failure
• Liver Toxicity

TOTAL BODY FORMULA SETTLEMENTS: Product liability lawyers are viewing potential Total Body Formula recall lawsuits for individuals who have suffered a reaction requiring medical treatment or hospitalization after daily use of the dietary supplement. Proof of purchase and use will be necessary to establish a claim. Submit information about a potential case to determine if you may be eligible to pursue a Total Body Formula Settlement.

Information about the two cases of this progressive and potentially fatal disease were first disclosed earlier this month in filings made by the drug manufacturers, Biogen Idec and Elan, with the Securities and Exchange Commission. Both users developed PML after taking Tysabri for at least 14 months, without simultaneous use of another multiple sclerosis drug.

These new cases are important, since they are the first reports of the rare brain disease among Tysabri users since the drug was reintroduced two years ago. It was removed from the market in 2005 after two deaths from three cases of PML were associated with the drug. It was allowed to return in 2006 with stricter guidelines and more prominent warnings about progressive multifocal leukoencephalopathy as a potential side effect of the treatment.

The FDA posted the information Monday through their MedWatch Alert System, urging doctors to only prescribe Tysabri to patients who are enrolled in a special program, known as the TOUCH Prescribing Program.

TOUCH is a risk minimization plan, where every patient is closely watched and monitored for PML and other adverse opportunistic infections. The program is also designed to assess the risk of PML, promote informed decisions among users and to minimize the number of disabilities and deaths due to progressive multifocal leukoencephalopathy.

Tysabri was initially launched in 2004, as an intravenous injection given every 28 days to treat multiple sclerosis (MS). Earlier this year, the FDA approved an additional use for Tysabri to treat Chron’s disease, where patients have failed other treatments, such as Remicade and Humira.

PML, also known as progressive multifocal leukoencephalitis, is characterized by progressive damage and inflammation at multiple locations in the brain, leading to permanent brain damage. Symptoms of PML include paralysis, weakness, impaired speech, and loss of vision. It is rare viral disease, which has no effective cure and can be fatal.

The two new cases of PML in Europe were reported among patients with multiple sclerosis who received Tysabri as a monotherapy, and both used the drug for more than a year.

Previous cases of PML associated with Tysabri had occurred only in multiple sclerosis patients who took other immunomodulatory drugs in combination with the medication. The FDA indicates that data suggests individuals who use Tysabri alone have a lower risk of developing PML than those who use it with other immunomodulatory medications.

No new cases of PML associated with Tysabri have been reported in the United States. At least 7,500 people have used the drug for more than a year in the U.S. and about 3,300 patients received the drug for at least one and a half years. Approximately 39,000 patients worldwide have been treated with Tysabri, with 12,000 of them having undergone treatment for at least a year.

The FDA and the manufacturer are reviewing changes to the product label to inform patients and prescribers that the use of Tysabri as a monotherapy has resulted in cases of progressive multifocal leukoencephalopathy.

Gadolinium MRI contrast agents, which allow the doctor to differentiate blood vessels from nearby tissue, have been linked to a potential risk of nephrogenic systemic fibrosis (NSF) for individuals with moderate to severe kidney problems.

The devastating progressive condition, which is also sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is associated with a hardening and thickening of the skin and connective tissue. The rigid and coarse skin that can form around the joints leads to severe restriction on movement, often requiring use of a wheelchair within weeks of the first symptoms.

There is no cure or consistently successful treatment for NSF, and it often contributes to a premature death. The FDA added a “black box” warning to gadolinium based contrast agents last year, advising doctors to screen patients for impaired renal function before an Enhanced MRI.

The FDA reserves the Fast Track Designation for products that are intended for treatment of serious or adverse conditions or have the potential for use in unmet medical needs. This designation helps to accelerate the process of development and review of these products by allowing more frequent interactions with the FDA and by various other means.

The FDA’s decision to allow a quicker approval process for fermoxytol was mainly driven by the potential for this newer diagnostic agent to serve as a safe alternative for individuals with chronic kidney disease to obtain a Vascular Enhanced (VE) MRI for assessment of peripheral arterial disease. If approved, it could be a life-saving alternative to the gadolinium-based contrast agent for individuals with advanced kidney disease.

Ferumoxytol is manufactured by AMAG Pharmaceuticals. The firm’s President and Chief Executive, Brian J.G. Pereira, said in a statement, “We plan to initiate a Phase II study of Ferumoxytol for VE-MRI for the detection of clinically significant arterial stenosis or occlusion in subjects with intermittent claudication (leg pain with walking) in the third quarter of 2008”.

AMAG Pharmaceuticals anticipates FDA action on its new drug application (NDA) in the second half of October 2008.

The FINRA (Financial Industry Regulatory Authority) arbitration award was entered in favor of Samuel P. Short, who alleged that Morgan Keegan placed him in investments that were not suitable for his needs, resulting in financial losses.

The arbitration claim was filed on January 14, 2008, involving mutual funds sold by Morgan Keegan, which are believed to be one of several Morgan Keegan bond funds which suffered substantial losses last year as a result of heavy investment in subprime mortgage backed securities.

Morgan Keegan is the investment banking and securities arm of Regions Financial Corp., which has offices in Alabama, Arkansas, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee and Virginia.

Investors who held shares in several Morgan Keegan bond funds have suffered losses in excess of 50% following the collapse of the subprime mortgage market last summer. The losses have been attributed to fund managers’ decisions to place a substantial portion of the fund assets in relatively new forms of mortgage backed securities, which had not been tested through market cycles.

Morgan Keegan class action lawsuits have been filed on behalf of all investors, and a number of individual arbitration claims have also been filed against the bank to recover investment losses. Morgan Keegan lawsuits allege that false and misleading statements were made about the bond mutual funds, and that investors were not informed about the extent to which the fund held illiquid collateralized securities.

The Financial Industry Regulatory Authority (FINRA) oversees nearly 5,000 brokerage firms throughout the United States, and most broker agreements require that disputes be resolved through FINRA arbitration.

In the Morgan Keegan arbitration claim filed by Samuel Short, he sought reimbursement for $19,364.00 in losses, and was awarded $15,000 by the arbitration panel, plus interest at the rate of 5% per annum. A request for $5,000 in punitive damages wasa denied.

The lawsuit was filed on August 22, 2008 in King County Superior Court in Washington state by Howard Steele, as personal representative for the estate of Lee Ann Steele.

Following a stroke, Lee Ann Steele was confined to a bed, unable to talk and had a tracheostomy tube to help her breath. Less than 24 hours after she was admitted to an Extendicare nursing home, she stopped breathing and suffered brain damage that ultimately led to her death.

Although her family was told that she would be cared for, staff at the Extendicare nursing home failed to check or clear her trach-tube the first day she was there, which the family alleges resulted in her death.

The nursing home lawsuit seeks class action status to represent all residents who were provided substandard care. The class action suit alleges that Extendicare made false representations and concealed facts intended to induce citizens to become residents at their nursing homes under the false pretenses that Extendicare would provide care consistent with their representations.

The lawsuit claims that Extendicare nursing homes in Washington operate with budgets that are so tight that appropriate staffing can not be provided, preventing residents from receiving the care and attention they are paying for.

Washington Extendicare nursing homes have received repeated citations from the Washington Department of Social Health Services (WDSHS) for providing inferior care that is in violation of rights of the elderly and ill residents. The WDSHS found about 35 deficiencies at one Extendicare nursing homes in 2007 and 30 in 2006, compared with a statewide average of only 9 deficiencies a year.

Understaffing at nursing homes is one of the leading causes of nursing home neglect injuries. When staffing levels are not as high as they should be, employees are unable to provide the care they should. When employees are placed in an impossible position, it can also increase the risk of nursing home abuse, when staff take out their frustrations on residents.

According to their website, Extendicare Health Services, Inc. runs 191 senior care facilities with approximately 19,200 beds in the United States.

The Pepperoni Pizza Hot Pockets were sold under the brand name of “Hot Pockets,” as opposed to the reduced calorie “Lean Pockets” which were involved in last months recall. However, both actions were taken because small pieces of plastic were found in the sandwiches.

The Hot Pockets consist of meats and cheese in a crust that can be heated in a microwave. The USDA classified both actions as a “Class I Recall”, since the consumption of the products could cause severe adverse health consequences, including death.

The recalled Pepperoni Pizza Hot Pockets were manufactured by Nestle on June 5, 2008, and sold throughout the United States. According to Nestle, the Hot Pocket recall only applies to 54 ounce, 12 pack cartons labeled “Hot Pockets Pepperoni Pizza - value 12 pack”. They contain a “Best Before” date of “Jan2010″, an establishment number of “EST 7721A” and a packaging code “8157544614D” printed on the side of the package.

Nestle discovered the latest Hot Pocket problems after they received at least four independent complaints where consumers reported pieces of hard red plastic were in the pizza products. Although no injuries have been confirmed as the date of the recall, it is unclear how many users could have eaten the defective Hot Pockets without reporting problems and thousands of the sandwiches could still be in consumers’ freezers.

On July 14, 2008, Nestle issued a Lean Pocket recall for nearly 200,000 pounds of their frozen stuffed chicken sandwiches which were produced on May 23, 2008. At the time of this earlier recall, the Nestle suggested that no other products were at risk, but clearly that was not the case.

It is unclear how the pieces of plastic made their way into the microwavable pockets, and Nestle has failed to provide any information for consumers about how they can be assured that other Hot Pocket and Lean Pocket products are not also affected.

As of the date this article was published, Nestle continues to prominently feature Pepperoni Pizza Hot Pockets on the home page of their Hot Pockets website, without any clearly labeled links to information about these recalls.

The investigation was initiated after data from a recent study indicated a possible connection between an increased incidence of cancer and Vytorin, which is a combination of Zetia (ezetimibe) and Zocor (simvastatin).

An early communication indicates that the FDA has an ongoing review of a potential safety issue, but that no conclusion has been reached about whether there is a causal relationship between the drugs and the identified safety concern.

Vytorin was approved by the FDA in 2004 and it is marketed jointly by Merck & Co. and Schering-Plough Corporation. It combines Zetia and Zocor, which is also available as generic simvastatin, to reduce low-density lipoprotein (LDL or ‘bad’) choleterol levels and increase high-density lipoprotein (HDL or ‘good’) cholesterol levels.

Earlier this year, concerns emerged about Vytorin after a study known as ENHANCE, demonstrated that it provides no medical benefits over older, cheaper drugs used to treat cholesterol. This has caused a great deal of controversy, as Zetia and Vytorin are widely used, with about 1 million people taking one of the drugs in 2007, and generated annual sales of about $5 billion.

Last month, data was released from another trial known as SEAS (Simvastating and Ezetimibe in Aortic Stenosis), which indicated that Vytorin was no better than a placebo in lowering the risk of heart disease in patients with partially blocked heart valves. A similar result was observed in the prevalence of aortic valve disease. An unanticipated finding in the study was that patients who took Vytorin 10/40 mg had a higher incidence of cancer than those who took the placebo.

The FDA indicates that they have received the preliminary data from the SEAS trial and anticipate receiving the final study report in about three months. The early communication does point out that preliminary data from two large ongoing cardiovascular trials involving Vytorin have not demonstrated an increased risk of cancer.

The FDA anticipates that it will take approximately nine months for them to complete their safety review into the potential Vytorin cancer side effects and make any decisions about whether regulatory actions are warranted.

The early communication does indicate that individuals taking Vytorin or another cholesterol drug should not stop taking their medication. If they have any questions or concerns about Vytorin side effects and the FDA early communication, they have been asked to contact their doctors.

The action was announced Wednesday by GlaxoSmithKline, the maker of Avandia, after they were ordered to issue new safety warnings in Australia for patients with certain medical conditions, such as mild forms of heart failure and unstable angina.

The Therapeutic Goods Administration (TGA), which is the Australian equivalent of the FDA in the United States, recently ordered changes to the guidelines for use of Avandia due to health concerns about heart side effects associated with the drug.

Avandia, which is known generically as rosiglitazone, is used to treat Type 2 diabetes by controlling blood sugar levels. It was a top selling drug, with annual sales of over $3 billion worldwide, until a study published in the New England Journal of Medicine in May 2007 indicated that users face a 43% increase in the risk of heart attacks and a 64% increase in the risk of cardiovascular death.

The new Australian guidelines indicate that Avandia should not be prescribed to patients who are on insulin or to patients with a history of cardiac problems. In addition, new patients should not be started on triple therapy, which is a course of three drugs: sulfonylurea, metformin and Avandia. The guidelines also apply to Avandamet, which is another drug that contains Avandia.

In November 2007, the FDA added a black box warning to the drug in the United States about Avandia side effects which could increase the risk of a heart attacks and congestive heart failure. Although many experts called for an Avandia recall in the U.S. due to the safety concerns, the FDA has allowed the diabetes drug to remain on the market with the strongest warnings possible, pending further studies.

A number of Avandia lawsuits have been filed throughout the United States by users who suffered a heart attack, stroke, congestive heart failure, severe bone fracture, macular edema or death.