Weight Loss Supplements Recalled

The U.S. Food and Drug Administration (FDA) www.fda.gov alerts Universal ABC Beauty Supply International, Inc., a Brooklyn based dietary supplement manufacturer, found the illegal, unapproved, and undeclared drug, Sibutramine, in the products the company distributes. Sibutramine, an FDA approved medication used as an appetite suppressant for weight loss, is a prescription approved medication by the federal government. The FDA has not approved the use of this prescription medication ingredient in 34 different Universal ABC Beauty Supply’s products.

The FDA issued a strong advisory to U.S. Consumers about the undeclared , Sibutramine, because the medication is known to cause the following harmful side effects:

-Substantially increase blood pressure and/or pulse rate in some patients
-High risk for patients with a history of coronary artery disease
-Harmful to consumers with congestive heart failure
-May be risky for patients who have arrhythmias
-Possible injury to patients with a medical history of stroke

Here's the product list:

PRODUCT NAME

1. ProSlim Plus, 60 capsules, bottle in box
2. 3 DAYS fit, 60 capsules, bottle in box
3. EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4. 24hours Diet, 60 capsules
5. Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6. 3X SLIMMING POWER, 60 capsules, bottle in box
7. Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8. Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9. Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360º C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

Dietary Supplement Recall

Hi-Tech Pharmaceuticals and the FDA have notified healthcare professionals and consumers of a nationwide recall of all products sold under the name Stamina-Rx.

An FDA lab analysis found that the product contained the undeclared ingredient, benzamidenafil. Benzamidenafil is in the same pharmacologic class as the phosphodiesterase type 5 (PDE5) inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved and poses a threat to consumers because it may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Patients with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the most susceptible to adverse effects from this product.

Source here.

FDA To Discuss Liver Risks With Tylenol,Other Painkillers

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The FDA will be taking a look at painkillers such as Tylenol next week.




The issue front and center relates to acetaminophen, a drug found in Excedrin as well as NyQuil and Theraflu, that can cause liver damage. Acetaminophen is the most widely used drug in America.


Acetaminophen is found in more than 100 products, including many prescription drugs administered by pharmacies. Much of its popularity is because - when taken at recommended doses - acetaminophen does not cause stomach discomfort or bleeding, unlike other drugs commonly used to reduce pain and fever, such as aspirin, ibuprofen and naproxen.

When, however, it's taken over the maximum amount of 4 grams per day, acetaminophen can cause liver damage, ranging from abnormalities in blood tests used to assess liver function to acute liver failure (ALF), and even death; a problem not caused by other over-the-counter painkillers.

Despite efforts since the early 1990s to reduce the incidence of acetaminophen-related liver damage, liver injury from acetaminophen overdose remains a serious public health problem. Source.



You'll be able to see the FDA at work by logging on to FDAAdvisoryCommittee.com


Source here.

Problems With Homeopathic Remedies?

An Associated Press analysis of the FDA's side effect reports has found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.


According to reports:

The AP also found that the FDA has set limits for alcohol in medicine, especially for small children, but they don't apply to homeopathic remedies. At least 20 ingredients used in conventional prescription drugs, such as morphine for pain, are used in homeopathic remedies.

Source here.

Given recent recalls of over the counter products, it's imperative that consumers carefully read the label of products like Zicam and others.

Zicam Recalled

Intranasal spray Zicam is being recalled as the FDA warns of 130 cases of anosmia- loss of the sense of smell.

Some Zicam users reporting anosmia say that the condition started with the first dose, while others indicate the symptoms did not appear until multiple doses had been administered. Officials have not yet determined if the condition is permanent, and fear the intranasal gel spray may be damaging nerves. The FDA expressed concern that consumers are using Zicam for a minor, “self-limiting condition” (such as a cold) and inadvertently risk damaging their quality of life permanently.

The affected products have been pulled from store shelves across the country and the FDA have advised that all remaining product should be discarded and not used for any reason.

Source here.

Zyprexa news

From Public Citizen and other sources:

Eli Lilly urged doctors to prescribe Zyprexa for elderly patients with dementia, an unapproved use for the antipsychotic, even though the drugmaker had evidence the medicine didn’t work for such patients, according to unsealed internal company documents.

In 1999, four years after Lilly sent study results to the FDA showing Zyprexa was not effectively alleviate dementia symptoms in older patients, the company started to market the drug to such patients, so says documents unsealed in insurer suits against the company.

Lilly has pleaded pleaded guilty earlier this year to a federal misdemeanor charge of illegally marketing Zyprexa for off-label uses to elderly consumers. The company admitted illegal promotions from September 1999 through March 2001, while denying such practices beyond that date.

Source here.

Liberty National Life Insurance News: Florida Licensure At Risk?

Liberty National Life Insurance could have its license suspended or revoked in Florida for refusing to write life policies based on nationality or travel to certain countries, state insurance regulators said Thursday.

Investigators from Florida's Office of Insurance Regulation spent nearly five months reviewing life insurance policy applications from Florida residents and found that consumers of Haitian descent were more likely than others to have their applications denied.

The OIR order to Liberty National gives the company 21 days to provide proof that it didn't violate state laws that prohibit discrimination.

Liberty National, based in Birmingham, Ala., didn't return a call from The Miami Herald asking for comment on Thursday's order.

According to OIR's order, 52.6 percent of Haitian applicants were denied compared to 18.2 percent of other foreign-born applications. For instance, although Liberty National's life insurance application asks if consumers have lived in the United States for more than a year, it applied a selective 10-year residency requirement to customers born in certain countries such as Haiti or Colombia.

TRAVEL CONCERN

Applicants with plans to travel to such countries as Haiti, Liberia or Honduras were also denied.

Investigators reviewed some 7,000 applications and found 1,149 violations, including 1,053 involving discriminatory practices.

Read more here.

Calrcon Skin Product: Partial Recall and Warning

he Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon because of high levels of disease-causing bacteria found during a recent inspection.

Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, issued a voluntary recall of some skin sanitizers and skin protectants marketed under several different brand names, the FDA said in a statement.

Consumers should not use any Clarcon products and should throw them away, the FDA said.

Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including some associated with unsanitary conditions, according to the agency. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage.

Examples of products that should be discarded include Citrushield Lotion, Dermasentials DermaBarrier, Dermassentials by Clarcon, Antimicrobial Hand Sanitizer, Iron Fist Barrier Hand Treatment, Skin Shield Restaurant, Skin Shield Industrial, Skin Shield Beauty Salon Lotion, Total Skin Care Beauty and Total Skin Care Work.

Link here.

Recent Avandia Medical Article

Avandia doesn't increase overall heart risks, according to final results of a large clinical study sponsored by the world's second largest drugmaker.

The study does seem to confirm that the medicine doubles the risk of heart failure -- a chronic condition where the heart struggles to pump enough blood around the body -- and also increases the danger of bone fractures.


You can find the article here.

Graves Disease Drug: Increased Risk for Liver Injury?

The FDA warned physicians that a drug used for 62 years to treat Graves' disease -- propylthiouracil, or PTU -- carries an increased risk for life-threatening liver injury.

The FDA said it has received 32 adverse event reports -- 22 in adults and 10 in children -- including 12 deaths and six transplants among adult users of the medication. In the pediatric population, the FDA said there were one death and six transplants linked to PTU use.

"Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy," the FDA said.

Source here.

Reglan: No MDL For Litigation

The JPML heard argument last week regarding a request by Plaintiffs' lawyers to consolidate proceedings involving Reglan. Reglan (metoclopramide) is prescribed for short-term treatment of gastrointestinal disorders.

The Petition was opposed by several drug maker of metoclopramide including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

What's next? Likely a mess of results or rulings in multiple courts, both State and Federal.

412(i) Tax Shelter Litigation

My friend Alabama attorney Chris Hellums is investigating abusive tax shelter creation. Here's his post from his blog:

Typically, these transactions will include an Insurance company, accountant, tax attorney, and a promoter (someone with an insurance background, perhaps an actuary, who knows how to structure the policy itself). These groups will use insurance brokerages and sub-agents (licensed in the various states) to sell the policies themselves.

HOW THESE PLANS WORK:

In the late 1990’s, the individuals and groups above devised a scheme to sell abusive tax shelters under the auspices of Section 412(i) of the tax code. A 412(i) is a defined benefit pension plan. It provides specific retirement benefits to participants once they reach retirement and must contain assets sufficient to pay those benefits. A 412(i) plan differs from other defined benefit pension plans in that it must be funded exclusively by the purchase of individual life insurance products. To create a 412(i) plan, there must be a trust to hold the assets.

The employer funds the plan by making cash contributions to the trust, and the Code allows the employer to take a tax deduction in the amount of the contributions, i.e. the entire amount. The trust uses the contributed funds to purchase some combination of life insurance products (insurance or annuities) for the plan. As the plan participants retire, the trust will usually sell the policies for their present cash value and purchase annuities with the proceeds.

The revenue stream from the annuities pays the specified retirement benefit to plan participants. These defendants (with the aid and knowledge of the insurance companies) used the traditional structure and sold life insurance policies with excessively high premiums. The trust then uses the large cash contributions to pay high insurance premiums and the employer takes a deduction for the sum of those large contributions. As you might expect, these policies were designed with excessively high fees or “loads” which provided exorbitant commissions to the insurance companies and the agents who sold the products.

The policies that were sold were termed Springing Cash Value Policies. They had no cash value for the first 5-7 years, after which they had significant cash value. Under this scheme, after 5-7 years, and just before the cash value sprung, the participant purchases the policy from the trust for the policy’s surrender value. In theory, you have a tax free transaction.

The IRS does not recognize the tax benefit of such a plan and has repeatedly issued announcements indicating that such plans are contrary to federal tax laws and regulations. These plans were targeted to high net worth individuals, including doctors, dentists, corporate executives, and professional athletes.

Read more at his blog, here.

Bausch and Lomb Settles Fungal Infection Lawsuits

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Contact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, "without a lot of outside distraction."

Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits — with dozens more individual claims yet to be resolved. The cost so far: Upward of $250 million.

Read more from this article here.