FDA Issues Recall For L-Citrulline Supplement Used To Treat Urea Cycle Disorders

This is the update from last week:

The FDA alerts health care professionals and patients that Medisca is voluntarily recalling certain lots of its L-citrulline product after testing indicated that it does not contain any L-citrulline

• Testing by Medisca indicated that L-citrulline, lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D do not contain L-citrulline. Pharmacists should see updated FDA Statement below for more product details.
• Medisca is voluntarily recalling all L-citrulline product with the above lot numbers.
• Health care professionals should discontinue dispensing from these lots, contact patients, and return all unused product to Medisca Inc. 
• Patients and caregivers should stop using any product with these lot numbers. 
• FDA has received several adverse event reports associated with Medisca’s L-citrulline product. FDA is investigating reports that may include additional lot numbers, continues to investigate the full scope of this issue and will continue to provide additional information as it becomes available. 
• Earlier, this information: FDA is notifiying health care professionals, patients, and caregivers of adverse events reported in patients who were administered L-citrulline repackaged and distributed by Medisca Inc. L-citrulline is used to treat certain urea cycle disorders, rare genetic disorders primarily diagnosed in children. FDA has received adverse event reports associated with potentially subpotent L-citrulline. Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.In addition to the identified lot number 96453, FDA is investigating reports that may include additional lot numbers.
  BACKGROUND: Medisca supplies pharmacies nationwide with L-citrulline. The product is sold to pharmacies and clinics in containers filled with powdered L-citrulline, and it may be compounded into tablets, capsules, or liquids by pharmacies, or remain a powder.
  RECOMMENDATION: FDA recommends health care professionals quarantine lots of L-citrulline from Medisca and not administer to patients until FDA provides additional information.
  
   

FDA warns against using Uncle Ben’s Infused Rice

From the FDA:

Fast Facts

• Government officials are investigating a cluster of illnesses associated with Uncle Ben’s Infused Rice Mexican Flavor sold in 5- and 25-pound bags.
• Out of an abundance of caution, the FDA is warning food service companies and consumers not to use any Uncle Ben’s Infused Rice products sold in 5- and 25-pound bags.
• These products are sold to food service companies that typically distribute to restaurants, schools, hospitals and other commercial establishments. However, the products may be available over the Internet and at warehouse-type retailers. 
• Food service companies and consumers who have purchased the products should not use the rice, and should return it to their point of purchase or dispose of it.     
• Uncle Ben’s Brand Ready to Heat, Boxed, Bag or Cup products sold at grocery stores and other retail outlets are not being recalled.

 

What is the Problem and What is Being Done about the Problem?

 

The FDA, the Centers for Disease Control and Prevention (CDC), and state and local officials have been investigating a cluster of illnesses associated with Uncle Ben’s Infused Rice Mexican Flavor sold in 5- and 25-pound bags. 

On Feb. 7, 2014, the FDA’s Coordinated Outbreak Response and Evaluation Network (CORE) was notified of a cluster of illnesses at three public schools in Katy, Texas. Thirty-four students and four teachers experienced burning, itching rashes, headaches and nausea for 30 to 90 minutes, before the symptoms went away. Uncle Ben’s Infused Rice Mexican Flavor with the lot number 351EKGRV01, made by Mars Foodservices of Greenville, Miss., was the common food item eaten by ill students.

 

On Dec. 4, 2013, the Illinois Department of Public Health notified CDC of 25 children with similar skin reactions following a school lunch that served an Uncle Ben’s Infused Rice product. North Dakota reported a similar incident that occurred on Oct. 30, 2013. Three children in a daycare and one college student experienced flushing reactions 45 minutes after consuming an Uncle Ben’s Infused Rice product.

 

Mars Foodservices is recalling all bags and all lot numbers of its Uncle Ben’s Infused Rice products produced in 2013: 

• UNCLE BEN’S INFUSED Rice Roasted Chicken Flavor (5- and 25-pounds)
• UNCLE BEN’S INFUSED Rice Garlic & Butter Flavor (5-pounds)
• UNCLE BEN’S INFUSED Rice Mexican Flavor (5- and 25-pounds)
• UNCLE BEN’S INFUSED Rice Pilaf (5-pounds)
• UNCLE BEN’S INFUSED Rice Saffron Flavor (5-pounds)
• UNCLE BEN’S INFUSED Rice Cheese Flavor (5-pounds)
• UNCLE BEN'S INFUSED Rice Spanish Flavor (25-pounds)

 

Although this product is not typically marketed to individual consumers, it may be available over the Internet and at warehouse-type retailers.

 

Uncle Ben’s Brand Ready to Heat, Boxed, Bag or Cup products sold at grocery stores and other retail outlets are not being recalled.

 

Investigation into this outbreak continues. 

 

What are the Symptoms of Illness/Injury?
The symptoms associated with this illness include a red burning/itching rash, headache, nausea, and flushness of the skin.

 

The symptoms appear very shortly after consuming the rice product and pass within 30 to 90 minutes.

 

 

What Specific Products are being Recalled? 

Mars Foodservices is recalling all bags and all lot numbers of its Uncle Ben’s Infused Rice products produced in 2013:

• UNCLE BEN’S INFUSED Rice Roasted Chicken Flavor (5- and 25-pounds)
• UNCLE BEN’S INFUSED Rice Garlic & Butter Flavor (5-pounds)
• UNCLE BEN’S INFUSED Rice Mexican Flavor (5- and 25-pounds)
• UNCLE BEN’S INFUSED Rice Pilaf (5-pounds)
• UNCLE BEN’S INFUSED Rice Saffron Flavor (5-pounds)
• UNCLE BEN’S INFUSED Rice Cheese Flavor (5-pounds)
• UNCLE BEN'S INFUSED Rice Spanish Flavor (25-pounds)

Low Testosterone Medications and Gels – Increased Risk of Non-fatal Myocardial Infarction?

Attorneys in my office are investigating a claimed link between these medications and heart injuries:
404 373 1800

Testosterone: What is it. In the fetal and embryonic stages of development, testosterone promotes the development of the scrotum and the formation of the structures involved in production. 

In adulthood, testosterone may play a part in sexual function, libido, hair loss, and it may play a role in the accumulation of abdominal fat.As men age, their testorone levels may slowly decline. This occurrence has been called “viripause”, “andropause” or “male menopause.”

This menopause may be caused by the testosterone receptors becoming less receptive, while the amount of free testorone in the body decreases. The decrease is due to an increase in a blood protein that binds with the hormone, rendering it useless.

The gradual fall in the testosterone levels (from 30 to 40 percent) is common in men between the ages of 48 and 70. As testosterone levels drop, men may experience a loss in muscle strength and function, increase in body fat, decrease in body density and a decrease in sexual function and drive. Of course, your physician first needs to rule out other medical causes for those changes.

From a study release in January, 2014, there is this discussion point: In older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.

From the study:

We examined risk of MI with TT prescription in all subjects. Since previous studies indicated that cardiovascular events appeared early in treatment, we focused on the 90 day interval following the filling of a first prescription. For those who did not refill their prescription, we also assessed the interval of 91–180 days. To examine potential effect modification by pre-existing disease, we estimated the effect of TT prescription by prior history of a heart disease diagnosis (ICD-9: 404, 414–414.07, 420–429). We also examined the RR for PDE5I and compared the RRs in the TT prescription and PDE5I cohorts.

Also:

Among men aged 65 years and older, we observed a two-fold increase in the risk of MI in the 90 days after filling an initial TT prescription, the risk declined to baseline in the 91 to 180 days after initial TT prescription, among those who did not refill their prescription. Since we censored follow-up at the first refill, and the supply for most prescriptions was 30 to 90 days, it is likely that there was little use of the medication in the 91 to 180 day post-prescription interval when the risk declined.

What are the products?

Testosterone therapy is most often administered as a gel, patch or injection. The following products treat low testosterone:

• Androderm (Actavis) – patch applied to the skin
• AndroGel (AbbVie Inc.) – topical gel applied to the skin
• Axiron (Lilly USA, LLC) – topical cream applied to underarm
• Bio-T-Gel (Teva Pharmaceuticals) – topical gel applied to skin
• Delatestryl (Endo Pharmaceuticals) – injection or solution
• Depo-Testosterone (Unigen Life Sciences) – injection solution
• Fortesta (Endo Pharmaceuticals) – topical gel applied to skin
• Striant (Auxilium Pharmaceuticals) – buccal tablet absorbed through the gums
• Testim (Auxilium Pharmaceuticals) – topical gel applied to skin
• Testopel (Auxilium Pharmaceuticals) – subcutaneous pellet

Risks of testosterone therapy

Men undergoing low T therapy with the following signs of health problems had the greatest increased risk of suffering a heart attack or stroke while taking low T treatments.

• plaque buildup
• artery blockage
• high cholesterol
• diabetes
• obesity

One doctor has explained: Testosterone increases the production of red blood cells, which can clump together or coagulate, essentially making blood thicker. That may be especially hazardous in men who have narrowed arteries because of aging and disease.

Talk with us if you think that you have a serious heart condition that you worry may be linked to use of any one of these products

- See more at: http://triallawyercenter.com/2014/02/12/low-testosterone-medications-and-gels-increased-risk-of-non-fatal-myocardial-infarction/#sthash.6vmbt6np.dpuf

CHANGING THE RULES OF THE GAME: THE PROPOSED AMENDMENTS TO FEDERAL CIVIL RULES SEEK TO ADD NEW LIMITS ON DISCOVERY-

My good friend, Attorney Mark Chalos recently wrote about the proposed changes to the Federal Rules of Civil Procedure. His blog post is a must read.  Take three minutes and let your legislators know that you opposed these rule changes:


 From his post:

Opponents argue that the data establish that the present 10 deposition limit and the current number of other allowable discovery requests are working well in practice and changes are unnecessary.  Some opponents suggest that further discovery restrictions discovery would be unfair to claimants who have the ultimate burden of proof in the litigation. Moreover, interrogatories and requests for admissions provide low cost means for discovering information and narrowing issues for trials and, therefore, new limitations of these mechanisms would provide little or no cost-savings.

 See more at: http://blog.legalsolutions.thomsonreuters.com/practice-management-2/changing-rules-game-proposed-amendments-federal-civil-rules-seek-add-new-limits-discovery/#sthash.9aKLHfDh.dpuf

The Post Mensing fight continue

AAJ continue to advocate on how best to limit the effects of Mensing on plaintiffs who have already been injured by generic drugs.

A different case: Brinkley v. Pliva, Inc.

One such case is Brinkley v. Pliva, Inc., currently pending in the U.S. Court of Appeals for the Eighth Circuit. The Brinkley case is similar to Mensing in that the injured patients took the drug metoclopramide (the generic form of the drug Reglan) and developed tardive dyskinesia, a severe and often irreversible neurological disorder.

Brinkley's lawyers, Benjamin A. Bertram and J. Scott Bertram of Betram & Graf in Kansas City, Missouri; David M. Peterson and Nicholas S. Clevenger of Peterson & Associates in Kansas City, Missouri; Thomas J. Preuss of Wagstaff & Cartmell in Kansas City, Missouri; Daniel J. McGlynn and Terrence J. Donahue, Jr., of McGlynn, Glisson, Moulton in Baton Rouge, Louisiana; and Bill Curtis hired CCL to work on the appeal. CCL's Senior Litigation Counsel Louis Bograd, who argued on behalf of Gladys Mensing before the Supreme Court, is handling the appeal for Ms. Brinkley.

Brinkley differs from Mensing in that the plaintiff used generic metoclopramide after July 2004, when the FDA approved a new warning against long-term use for the Reglan label. Pliva, the manufacturer of the generic metoclopramide Ms. Brinkley took, never added this new warning to its labeling, but it could have. Once the change to the Reglan label had been approved, federal regulations permitted Pliva to add the same warning to its label without prior agency action.

Bograd says that, because federal law would have permitted this label change, Pliva may be held accountable and a state-law claim for failure to warn is not preempted by federal law.

The Sixth Circuit and many lower courts agree that claims like Brinkley's are not preempted, but the Fifth Circuit has rejected this argument. Brinkley provides an opportunity for the Eighth Circuit to weigh in on this issue.

The bottom line is that all drug manufacturers should have a duty to warn patients of the risks of using their products. Accountability matters, and this case may prove pivotal in advancing this cause for patients injured or killed by dangerous generic drugs before the FDA's new proposed rule can take effect.