Friday, March 30, 2012

Eye Solution Recalled

Two of India's top drugmakers are grappling with product recalls after regulators in the U.S. spotted signs of impurities in their drugs. Sun Pharmaceuticals is recalling about 155,000 bottles of an eye solution, while two of Cipla's top pharma partners have pulled products made at its Goa plant.

Thursday, March 29, 2012

Georgia Supreme Court Ruling Regarding Apportionment

The Georgia Supreme Court has ruled on a key point of the state's tort reform from 2005. The case is McReynolds v. Krebs.   

In the underlying action, Krebs was injured when the vehicle she rode in was struck by a vehicle driven by McReynolds. Krebs sued McReynolds for negligence, and the manufacturer of the vehicle, General Motors, alleging uncrashworthiness. 

McReynolds then filed a crossclaim against GM. GM settled Krebs’ claims against it, and McReynolds tried  to force disclosure of the terms of the confidential settlement. GM moved to dismissed McReynolds’ crossclaim claiming the Tort Reform Act of 2005 abolished joint and several liability, and McReynolds responded that the amendments did not abolish her right to contribution or setoff. The trial court dismissed the cross-claim against GM and denied McReynolds’ motion for summary judgment that she reached an enforceable settlement with Krebs based on correspondence from her insurer.
The Court of Appeals unanimously affirmed the trial court’s decision.
McReynolds petitioned for certiorari  on the interpretation of the Tort Reform Act related to contributions, apportionment and setoff, and also the enforceability of the settlement agreement. 
The issues for the Georgia Supreme Court were: 
  1. Did the Court of Appeals correctly construe OCGA § 51-12-33 to require a trier of fact to apportion an award of damages among multiple defendants when the plaintiff is not at fault?
  2. Did the Court of Appeals correctly find that McReynolds’s insurer made a counteroffer in response to Krebs’s settlement demand?
Last week, the Supreme Court affirmed  the Court of Appeal. Justice Nahmias first explained that apportionment of damages must take place regardless of whether the plaintiff is at fault. In light of this holding, the Court found there was no error in dismissing the cross-claim and set-off. 

"Damages are apportioned among tortfeasors according to their percentages of fault, regardless of whether the total amount of damages was first reduced under subsection (a) to account for the plaintiff's share of liability," the justice wrote.

"Accordingly, we hold that in applying § 51-12-33, the trier of fact must 'apportion its award of damages among the persons who are liable according to the percentage of fault of each person' even if the plaintiff is not at fault for the injury or damages claimed.

"In light of this holding, there was no error in the dismissal of McReynolds' cross-claims for contribution and set-off against GM."

As to the counteroffer issue, the Court noted that Krebs' offer made no mention of liens, nor did it contemplate any particular resolution of the hospital lien or any other liens as a condition of settlement.

"As we explained in Frickey, while a 'mere request for confirmation that no liens exist' will not transform a purported acceptance into a counteroffer, an added condition involving the 'resolution of... actual and potential liens of the health care providers' will," Nahmias wrote.

"Thus, like the trial court and the Court of Appeals, we construe the response by McReynolds' insurer to Krebs' settlement offer, proposing to resolve the hospital and other liens 'as part of this settlement,' as a counteroffer rather than an unconditional and unequivocal acceptance. Accordingly, no binding settlement agreement was formed."
Six Justices also found that response by the insurer was a counteroffer rather than an acceptance. Justice Melton dissented from this portion of the opinion, and would have found the insurance carrier fully accepted the offer.

Dietary supplements not without risks

From the Mayo Clinic's site, a timeless article:

Before you try any dietary supplements, take a close look at the bottle and the science behind the claims. Then proceed with caution. Here's why:
  • Just because you can purchase a supplement, that doesn't mean it's safe. Dietary supplements don't undergo the same scrutiny that's required of prescription medications.
  • Dietary supplements, including herbal supplements, aren't benign. Whether they're in the form of pills, drinks, powders or foods, supplements can have strong effects in the body. Supplements can also interact with prescription medicines, leading to potentially dangerous reactions.
  • "All natural" on the bottle is no guarantee that a supplement is in fact all natural. In recent years, the Food and Drug Administration has discovered chemicals, prescription drugs and steroids in some supplements.
  • Few supplements have rigorous science to support their claims. In all fairness, it's possible the science just isn't there yet. Whatever the reason, you're in uncharted waters when it comes to most supplements.
If you're currently taking or considering taking dietary supplements, keep a few key points in mind:
  • Be skeptical. If a claim seems too good to be true, it probably is. When in doubt, ask your doctor or pharmacist.
  • Talk to your doctor. Tell your docto.
  •  If you're taking a supplement and if you experience any problems with it.
Read more here:

Hydroxycitric Acid Dietary Supplement-Related Herbal Nephropathy

We see hydroxycitric acid as an ingredient in may products sold over the counter. Here is a recent study regarding it:


Herbal preparations are unregulated and widely used because of public perception of being “harmless” and “natural.” Hydroxycitric acid, an extract from the herb garcinia cambogia, is a popular weight-loss supplement used for centuries in Asia. Its effect on weight loss, although being demonstrated in animal studies, may be effective on humans, but with harmful consequences. This is the first report of acute kidney injury caused by an herbal product containing hydroxycitric acid.

Case Presentation
A 38-year-old obese woman presented to the emergency department for treatment of abdominal pain, nausea, and vomiting of 3 days duration. Her medical history was significant for gastroesophageal reflux. The patient said she generally took no medication, but she had begun taking ranitidine 150 mg/d a few days previously and used an “occasional” hydrocodone/acetaminophen 5/500 tablet to ameliorate her abdominal pain. She denied use of nonsteroidal anti-inflammatory drugs and did not initially disclose her hydroxycitric acid herbal supplement use (500 mg/d 5 days per week for 1 year) until directly questioned by the admitting physician.

The patient's positive findings were a hypertensive state of 145/76 mm Hg, an elevated creatinine level of 5.8 mg/dL (compared with a baseline of 0.79 mg/dL), and a fractional excretion of sodium greater than 4. Negative laboratory results were anti-nuclear and anti-neutrophil cell antibodies, C3, C4, and serum protein electrophoresis. Renal artery ultrasound was normal.

After the supplement was discontinued, her creatinine increased to 6.2 mg/dL (glomerular filtration rate of 8 mL/min) over the next day, necessitating nephrology to institute hemodialysis. Consequently, her renal function sufficiently improved, so no renal biopsy was performed. She was discharged on day 7 with a creatinine level of 1.6 mg/dL and glomerular filtration rate of 38 mL/min.

The temporal relationship of her symptoms, the prolonged use of hydroxycitric acid, the absence of other nephrotoxic agents except ranitidine, and the improvement of renal function after cessation of hydroxycitric acid support the impression of acute renal failure secondary to herbal nephropathy.

A New One: "Cosmeceuticals"

As we dig through sites to bring information to light here, I stumbled across the term cosmeceuticals. On Wiki, we find this: Cosmeceuticals refers to the combination of cosmetics and pharmaceuticals. Cosmeceuticals are cosmetic products with biologically active ingredients purporting to have medical or drug-like benefits.
What's troubling to me is the seemingly industry focused grafting of two words - cosmetics and pharmaceuticals - to suggest that an over the counter product would have medical like properties. It's not just troubling to me or others. A Bloomberg article notes this: 
The industry calls them “cosmeceuticals,” a term that doesn’t exist in regulation,Michael Landa, director of the Food and Drug Administration’s Center for Food Safety and Applied Nutrition, said in testimony prepared for a House subcommittee hearing. The claims companies make that the products contain active ingredients may classify them as drugs, he said.
Retinol and peptides weren’t listed as ingredients in any cosmetics before 2005, Landa said in his written remarks to the House Energy and Commerce health subcommittee. Retinol is now registered in 200 items, while peptides are listed in 1,200 product statements voluntarily submitted to the FDA, he said.
The report referenced in that article is titled  “EXAMINING THE CURRENT STATE OF COSMETICS." Here is what is known:
Cosmetics are not not required to submit safety substantiation data to the Agency, nor to make it available to the Agency.  Under the  FD&C Act, cosmetic products and ingredients (with the exception of color additives) are not subject to FDA premarket approval or premarket notification.    
This class of products  presents new regulatory challenges in a number of ways, including how such products should be regulated and with what requirements such products should comply.  Many products in this category are advertised as containing “active ingredients,” which, by virtue of the ingredients  themselves or the claims made for the product, may cause the product to be classified under the FD&C Act as a drug.  

What is known about the industry? There are eight billion personal care products on the market.  According to the report,  estimates of annual U.S. sales of these products range from $54 to over $60 billion.
The report is seeking approval for new fees and a registry, and the grand total of the fees generated by the registry would be less than $20 million. In other words, they are seeking to throw a needle into a hurricane in an effort to address safety in a multi billion dollar industry that is creating a medical benefits-sounding term. My money is on the FDA failing consumers in this area. 


Wednesday, March 28, 2012

Lawsuit in Arkansas starts next week over Risperdal

A jury trial is scheduled to begin Monday over accusations that a pharmaceutical company illegally marketed an anti-psychotic medication in Arkansas.

Arkansas Attorney General Dustin McDaniel filed a lawsuit against Johnson & Johnson, claiming that its Janssen Pharmaceuticals subsidiary concealed the potential health risks of the drug Risperdal. The suit also alleges that the company promoted it for unauthorized uses in violation of Arkansas' Deceptive Trade Practices Act and the Medicaid Fraud False Claims Act.

Risperdal is used to treat schizophrenia and bipolar disorder.

Club Chef LLC Recalls Salsa Because Of Possible Health Risk

News of a recall this week involving salsa:

Club Chef LLC is recalling its 12 oz., 16 oz. and 5 lb. Salsa products because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The product is sold in 12 oz. (Private Selection brand name) and 16 oz. (heinen’s brand name) clear plastic packages and 5 lb. plastic trays (foodservice distributors) marked with Use by Date of 3/27/2012. UPC numbers located on the packages are as follows:

    Private Selection 12 oz. brand:
    heinen's 16oz. brand:
PICO DE GALLO – UPC# 11111091135 HOT SALSA – UPC# 2060100024
HOT SALSA – UPC# 1111091139 MILD SALSA – UPC# 2060100026
MILD SALSA – UPC# 1111091137  
The identified product was distributed to retailers and foodservice distributors on 3/14/12 and 3/15/12 within eleven states: Ohio, Kentucky, West Virginia, Arkansas, Mississippi, Missouri, Tennessee, Virginia, North Carolina, Indiana and Illinois.

While there have been no illnesses reported to date in connection with this problem, Club Chef is collaborating closely with the FDA and adhering to all safety regulations and standards.
The potential for contamination was noted after a random test by the Ohio Department of Agriculture in a store in Ohio which revealed the presence of Salmonella in a case of Jalapeno peppers. Jalapeno peppers are one of the ingredients in the Salsa.

March 2012 Pradaxa Georgia News: Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

Pradaxa® (dabigatran etexilate mesylate) is a direct thrombin inhibitor anticoagulant, which became FDA-approved on October 29, 2010. 

Pradaxa® reduces the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa® is being prescribed and used to replace existing successful blood thinners like Warfarin (Coumadin), the main agent used in the United States.

Anticoagulants reduce blood clotting, which is why they are more commonly called blood thinners. Anticoagulants like Pradaxa® are most commonly used in patients with atrial fibrillation, or an irregular heartbeat. This is because atrial fibrillation increases the risk of stroke, which is many times higher in patients with an irregular heartbeat.

Here is what the FDA had to say:

 (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.
FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.
Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

Atrial fibrillation (AF or A-fib) is the most common cardiac arrhythmia (irregular heart beat). It may cause no symptoms, but it is often associated with palpitations, fainting, chest pain, or congestive heart failure. AF increases the risk of stroke; the degree of stroke risk can be up to seven times that of the average population, depending on the presence of additional risk factors (such as high blood pressure). It may be identified clinically when taking a pulse, and the presence of AF can be confirmed with an electrocardiogram (ECG or EKG) which demonstrates the absence of P waves together with an irregular ventricular rate.

In AF, the normal regular electrical impulses generated by the sinoatrial node are overwhelmed by disorganized electrical impulses usually originating in the roots of the pulmonary veins, leading to irregular conduction of impulses to the ventricles which generate the heartbeat. AF may occur in episodes lasting from minutes to days ("paroxysmal"), or be permanent in nature. A number of medical conditions increase the risk of AF, particularly mitral stenosis (narrowing of the mitral valve of the heart).

Painkiller Opana, Scourge of Rural America

From Reuters:

Prescription drug abuse is the new scourge of rural America. It now leads to more deaths in the United States than heroin and cocaine combined, and rural residents are nearly twice as likely to overdose on pills than people in big cities, according to the Centers for Disease Control.
While methamphetamine addiction has long been associated with small towns, prescription painkillers have overtaken meth as the most abused drugs in places such as southern Indiana, according to local authorities.
Opana is the hot new prescription drug of abuse, sometimes with tragic consequences.
At least nine people have died so far this year from prescription drug overdoses in Scott County, Indiana. Most of the fatalities involved Opana, according to county coroner Kevin Collins.

Tuesday, March 27, 2012

Jamba Juice
Jamba Juice (Photo credit: Wikipedia)
A California resident has filed a putative class action in federal court against the Jamba Juice Co., alleging that it falsely advertises its fruit smoothie kits as “All Natural,” when they actually contain “unnaturally processed, synthetic and/or non-natural ingredients,” such as ascorbic acid, citric acid, xanthan gum, and steviol

The steviol glycosides are responsible for the sweet taste of the leaves of the stevia plant (Stevia rebaudiana Bertoni). These compounds range in sweetness from 40 to 300 times sweeter than sucrose. They are heat-stable, pH-stable, and do not ferment. They also do not induce a glycemic response when ingested, making them attractive as natural sweeteners to diabetics and others on carbohydrate-controlled diets.

March 27, 2012 DMAA News: DMAA - A "party pill" in NZ - Banned

While the FDA just sits there and watches others like the DoD take action on DMAA, countries are deciding to take action. Wouldn't it be refreshing if that happened here?

In New Zealand:  Associate Health Minister Peter Dunne has announced a common ingredient in party pills is being banned and should be off the market in early April.

The Temporary Class Drug Notice has been placed on DMAA (1,3-dimethylamylamine), which will be the 21st substance banned under last year’s drug law amendments. 

Mr Dunne says DMAA, which has been linked to increased blood pressure, headaches and vomiting, is “the first substance other than a synthetic cannabinoid to be banned using the temporary notices”.

“I think this decision demonstrates the wider use of Temporary Class Drug Notices to protect the health and well being of New Zealanders… it is not just about party pills and synthetic cannabis.”

The notice means that all products containing DMAA will effectively be banned, and must be removed from shelves and no longer sold over the internet in New Zealand from April 9.

Read more:

Monday, March 26, 2012

Vitamin E No Help for Heart Failure Risk

Vitamin E supplements probably aren't doing anything to prevent the development of heart failure in women, an analysis of the Women's Health Study showed.

After adjustment for potential confounders, taking 600 IU of vitamin E every other day was not associated with incident heart failure (HR 0.93, 95% CI 0.71 to 1.21, P=0.59), according to Claudia Chae, MD, MPH, of Massachusetts General Hospital in Boston, and colleagues.

But because there were relatively few heart failure events during follow-up, a small-to-moderate effect of supplementation could not be excluded, the researchers reported online in Circulation: Heart Failure.

Background—Oxidative stress may contribute to the development of heart failure (HF); however, an increased risk of HF has been observed with antioxidant therapy in secondary prevention trials. No large clinical trials have addressed the role of antioxidant therapy in the primary prevention of HF. 

Methods and Results—We examined the effect of vitamin E and HF risk in 39 815 initially healthy women, aged at least 45 years at baseline, who were enrolled in the Women's Health Study, a randomized, double-blind, placebo-controlled trial of vitamin E (600 IU every other day). Over a median follow-up of 10.2 years, there were 220 incident HF events. In proportional hazards models, adjusting for age and randomized aspirin and beta carotene treatment, vitamin E assignment did not significantly affect HF risk (hazards ratio [HR], 0.93; 95% CI, 0.71–1.21; P=0.59). These results did not change with multivariate adjustment for other risk factors, including interim myocardial infarction. In a prespecified subgroup analysis, vitamin E was inversely related to developing HF with normal ejection fraction (≥50%) with HR 0.59 (95% CI, 0.38–0.92; P=0.02), but there was no statistically significant effect on the risk of developing systolic HF (HR, 1.26; 95% CI, 0.84–1.89; P=0.26). 

Conclusions—In this population of apparently healthy women, vitamin E did not affect the overall risk of HF

St Jude’s faulty Riata leads cause 22 deaths

Worth a read, from this abstract in an article published in Heart Rhythm:

Riata and Riata ST leads (St. Jude Medical, CA) were recalled in 2011. These leads are prone to externalized conductors. However, it is electrical malfunctions, which may result in serious adverse events, including death.

The conclusion?

 Riata and Riata ST ICD leads are prone to high-voltage failures that have resulted in death


The purpose of this study was to assess the deaths of Riata and Riata ST patients that have been reported to the FDA in order to determine if they were due to lead malfunction. A similar analysis was performed for Quattro Secure leads (Medtronic, Inc., Minneapolis, MN)


In February 2012 we searched the FDA’s MAUDE database for deaths associated with Riata, Riata ST, and Quattro Secure leads. A lead-related death was a sudden or unexpected death accompanied by evidence of lead malfunction; an indeterminate death was a death that was non-sudden, or evidence of lead malfunction was not provided; a not lead-related death was a death that was non-sudden, and/or there was no evidence that the lead contributed to the patient’s demise.


The MAUDE search found 133 deaths; of these, 22 were caused by Riata or Riata ST lead failure, and 5 were caused by Quattro Secure failure. Riata and Riata ST deaths were typically caused by short-circuits between high voltage components. No death was due to externalized conductors.


Riata and Riata ST ICD leads are prone to high-voltage failures that have resulted in death. These failures appeared to be caused by insulation defects that resulted in short-circuiting between high-voltage components. Externalized conductors were not a factor in these deaths.

Alzheimer's Drug Risks

Professors Lisa Schwartz and Steven Woloshin of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice are raising alarms about a recent Food and Drug Administration decision to approve a new dosage for the  best-selling Alzheimer’s drug Aricept (donepezil). The decision “breached the FDA’s own regulatory standard” and has led to “incomplete and distorted messages” about the drug, they warned in the latest British Medical Journal.

Did Abbott Laboratories Chinese Infant Formula Violate China National Standards?

Here's a PR Newswire post that ran in a local news' .com site:

An infant formula product produced by Abbott Laboratories (ABT.NYSE), failed to reach China national safety standards and tested worst among a selection of six infant formula powders sold on the Chinese market, according to a research report released by Hong Kong-based research house CER Research on Thursday.
The release of the research report on Abbott's Similac Stage 1 milk powder product coincided with Chinese media reports of a father in the China city of Hangzhou who says he had found half of a condom inside an Abbott milk powder package which he had purchased for his daughter.

CER Research said it sent samples of six infant formula products bought in Shanghai and Hong Kong to a professional food testing laboratory, Muva Kempten in Allgau, Germany, for analysis, and had planned to use the Abbott product as a benchmark for quality, on the assumption that it would top the results.

Read the rest of the PR wire release here at the source:

Read more here:

Saturday, March 24, 2012

GA March 23, 2012 Mesh News: Prolift Pelvic Mesh Product Sold For Over 3 Years Without Necessary FDA Clearance

 Read more:

The FDA confirmed in a March 16, 2012 communication released to Bloomberg News that the vaginally placed pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc. since March, 2005, was initially marketed without any clearance or approval from the FDA. Ethicon attempted to justify this decision, claiming the Prolift, a vaginal mesh medical device for treatment of pelvic organ prolapse, was legally marketed pursuant to the 510K for a significantly different product.In the March 16, 2012 communication, FDA spokesperson Morgan Liscinsky stated that the: “FDA disagreed with this assertion.” The FDA statement unequivocally rejects Ethicon’s contention that the Prolift was legally marketed under the 2002 clearance provided to the other device known as Gynemesh PS.

Read more:

Sunday, March 18, 2012

Attorneys Mark Zamora (404-451-7781)and Joey James (256-764-0095) Dateline NBC Report

Our lawyers investigate claims of wrongdoing by companies whose products allegedly injure hard working consumers. Joey and I have known each other for more than 20 years, and we worked together investigating claims involving supplements and products.  

While we do our level best to right a wrong and seek justice, it is incumbent on all citizens to push for real reform at the FDA. The FDA lacks sufficient funding and personnel to oversee the safety of products people put in and on their bodies.

The FDA has its hands full. Here are recent reports, below that show that companies that don't want to follow FDA regulations simply don't. They then put their products on the market, putting innocent people at risk.


Public Notification: “ViaXtreme” Contains Undeclared Drug Ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “ViaXtreme,” a product for sexual enhancement sold on various websites.  Claims made for the product falsely state that it contains “all-natural ingredients” and that it has “no side-effects.”   
FDA laboratory analysis confirmed that “ViaXtreme” contains the undeclared ingredient sulfoaildenafil.  Sulfoaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED).  This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. 
Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

 Herbal Nitro Inc.

 On May 3 through May 10, 2011, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement firm located at 35133 Ravencrest Ct., Yucaipa, CA. During the inspection, you informed our investigators that your firm is an own-label dietary supplement distributor that enters into agreements with contract manufacturers to manufacture your dietary supplement products, and supplies such contract manufacturers with raw materials, including components used in the manufacture of your dietary supplement products.  You also stated that these contract manufacturers are required to meet your firm’s dietary supplement formulations.  As an own-label dietary supplement distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm’s name, FDA considers you to be a manufacturer of dietary supplements. As such, you have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce.

During the inspection, our investigators found that you have significant violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). 
These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111. 
Your significant violations are as follows:
1. Your firm failed to establish specifications for identity, purity, strength, and composition for each component that you use in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b). Specifically, during the inspection, you told our investigators that your firm has not established any specifications for the components that your firm uses in the manufacture of your dietary supplement products

Remember, this is in 2011

When a company is caught - what happens? In NJ a company basically said it did not care what agreement it reached regarding a supplement. After agreeing to stop making dangerous products, the company opened a new office and did just that.

The entire process took almost 3 years to close out.

 A Trenton, N.J., jury Wednesday found Paterson, N.J.-based dietary supplement companies Quality Formulation Laboratories Inc. and American Sports Nutrition Inc., as well as their owner, Mohamed S. Desoky, and managers Ahmad Desoky Esq. and Omar Desoky, guilty of multiple counts of criminal contempt of court for violating a consent decree, the Justice Department announced today.   The decree was entered by the U.S. District Court for the District of New Jersey on March 16, 2010.   The decree, which resolved a civil action filed by the Justice Department as the result of an investigation by the Food and Drug Administration (FDA), mandated Mohamed S. Desoky and the two companies shut down all manufacturing and distribution activities of food products.

The defendants’ businesses manufactured and distributed food products and supplements, including many varieties of protein powder mixes, as well as other powder mixes and dietary supplements.   The products were distributed under the American Sports Nutrition brand and many other private labels to locations throughout the United States.

The complaint in the civil case that led to court order alleged that the defendants, which included Mohamed S. Desoky, Quality Formulation Laboratories Inc., and American Sports Nutrition Inc., adulterated food by manufacturing it without following FDA’s regulations regarding current good manufacturing practice (CGMP) requirements, and causing the adulteration of food by preparing it under insanitary conditions whereby it may have become contaminated with filth (as a result of rodent activity) or may have been rendered injurious to health (as a result of cross-contamination with a major food allergen).

The complaint alleged that the defendants caused misbranding of food because the food contained a major food allergen (milk) not declared on the product labels.   The civil complaint went on to allege that defendants’ failure to have adequate sanitizing and cleaning operations and follow their own procedures for manufacturing products on dedicated equipment, may have led to food being contaminated with this major food allergen by virtue of "cross-contamination" or "cross-contact" in the manufacturing process. The civil complaint alleged that during an FDA inspection of the defendant’s facility in December 2008 and January 2009, FDA investigators observed a dead rodent - cut in half- on a blender motor platform; a dead rodent, surrounded by rodent excreta pellets in an area used to store near-finished product; and, on two occasions, a live rodent running through the blending room. Additionally, the complaint alleged that investigators observed bags of raw ingredients that were gnawed through by rodents and covered in rodent urine and excreta pellets.

The consent decree that settled the civil action required that defendants shut down their manufacturing operation and not reopen there or elsewhere without first correcting these violations and getting FDA’s approval to reopen.   The criminal contempt charges alleged that Ahmad Desoky and O. Desoky, with knowledge of the court’s order, assisted their father, Mohamed S. Desoky, in violating the order, and thus were criminally liable for the violations even though they were not named as defendants in the original civil case.

The petition for criminal contempt charged all five defendants with violating the decree almost immediately upon its entry by setting up operations at a separate location in Congers, N.Y., to which they transported their employees and equipment.   In addition, the petition alleged that the defendants violated the decree by failing to notify FDA of this relocation of their operations.  All five defendants were found guilty of these charges.  

Thursday, March 15, 2012

Coconut Water Manufacturer Sued for False Label Claims

In a recently-filed lawsuit, Patrick J. Vital, a resident of the state of Florida, filed a class action complaint against One World Company, LLC (also known as One Natural Experience and doing business as One World Enterprises, LLC) for providing false information on the nutritional labels of their products, One Natural Experience Coconut Water (O.N.E.).
Coconut water has recently become popular, especially with athletes, due to it high potassium content, as well as other nutrients such as sodium, magnesium, phosphorus and vitamin C. According to the label on the packaging of O.N.E., this brand of coconut water is a "good source of electrolytes", which makes the drink appealing for rehydration after exercise.

Kim Kardashian Faces Diet Pill Lawsuit

A lawsuit filed by four former QuickTrim customers, alleges Kardashian markets the products as being clinically shown to quicken the metabolism, curb the appetite, and promote weight loss. In reality, QuickTrim is nothing more than an expensive caffeine pill loaded with "gimmicky" ingredients -- such as acai berry and raspberry ketones.
Of course, such gimmicks are common in the diet industry. Diet supplements, such as Zantrex and Metabolife, also contain more than one source of caffeine. Supplement companies often load supplements with ingredients harboring this drug, hiding under discreet names such as cacao beans, guarana, or yerba mate.
Oddly enough, the details of the lawsuit may actually work in QuickTrim's favor. Makers of the lawsuit allege the supplements are chocked full of caffeine, even exceeding the FDA limits. 

March 2012 Pradaxa News for GA and FL

Pradaxa Use

Pradaxa is a blood thinning agent (anticoagulant) that is prescribed to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Pradaxa is manufactured by Boehringer Ingelheim. The U.S. Food and Drug Administration, FDA, approved Pradaxa on October 19, 2010.

FDA Safety Communication Regarding Pradaxa Serious Bleeding Events

In a Safety Communication dated December 7, 2011, the FDA stated that it is currently evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). While bleeding is a known complication of blood thinning medications, the FDA wishes to determine if life threatening bleeding complications occur more commonly with Pradaxa than would be expected.
Because Pradaxa is prescribed to reduce the risk of blood clot formation the FDA advised that patients should not stop taking Pradaxa without talking to their healthcare professional first. The FDA also advised that patients should call their healthcare professional and seek immediate care if they develop any signs or symptoms of bleeding such as:
  • Unusual bleeding from the gums
  • Nose bleeding that happens often
  • Menstrual or vaginal bleeding that is heavier than normal
  • Bleeding that is severe or that you cannot control
  • Pink or brown urine
  • Red or black stools (looks like tar)
  • Bruises that happen without a known cause or that get larger
  • Coughing up blood or blood clots
  • Vomiting blood or vomit that looks like coffee grounds
In addition to the FDA’s efforts, Pradaxa is being monitored for an increased risk of serious or irreversible bleeding by drug regulatory agencies worldwide. According to the European Medicines Agency as of November 6, 2011, a worldwide total of 256 spontaneous case report of serious bleeding resulting in death were recorded in association with the use of Pradaxa.

Pradaxa Bleeding Risks and Irreversible Bleeding

In January of 2012 the FDA posted on its website revised product labeling for Pradaxa.  The revised label indicates that at this time, there is no specific agent or medication that will reverse a Pradaxa bleeding event.  Instead, the patient’s body must eliminate Pradaxa via the renal (kidney) system.  Further complicating this matter is that Pradaxa’s anticoagulant (blood thinning) activity and half-life are increased in patients with kidney impairment.

The FDA site has this information:

The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
Facts about Pradaxa
(dabigatran etexilate mesylate)
  • A blood thinner (anticoagulant) known as a direct thrombin inhibitor.
  • Approved to reduce the risk of stroke and blood clots (systemic embolism) in patients with non-valvular atrial fibrillation.
  • Available as 75 mg and 150 mg oral capsules.
  • From approval in October 2010 through August 2011, a total of approximately 1.1 million Pradaxa prescriptions were dispensed and approximately 371,000 patients received Pradaxa prescriptions from U.S. outpatient retail pharmacies.1
At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label (SeeAdditional Information for Healthcare Professionals).  
Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.
Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.