Injuryboard Commentary - fda

Slim-Fast® Ready-to-Drink Products in Cans Recalled Due to Possible Health Risk

Paul Napoli — Mon, 07 Dec 2009 11:12:25 GMT

December 4, 2009

Unilever United States, Inc. of Englewood Cliffs, NJ, in cooperation with the U.S. Food and Drug Administration (FDA), has voluntarily recalled all Slim-Fast® Ready-to-Drink products in cans due to the possibility of contamination with the microorganism Bacillus cereus.

People infected with food borne Bacillus cereus experience diarrhea, abdominal cramps, nausea and occasionally vomiting within 1/2 hour to 15 hours after consumption of contaminated food. Symptoms persist for 24 hours in most instances.

All Slim-Fast RTD (Ready to Drink) products in cans, regardless of flavor, Best-By date, lot code or UPC number are recalled. The products are packaged in paperboard cartons that contain four; six or 12 steel cans of 11 FL OZ (325 mL) each and distributed nationally. Certain retail outlets also sold individual cans.

Unilever United States, Inc. initiated the recall after it conducted quality testing on Slim-Fast RTD products in cans. The company is in the process of identifying and correcting the production issue and will resume production and shipment of the product when the issue has been addressed and corrected.

Consumers who have purchased Slim-Fast® RTD products in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund. The Consumer Services Center is open Monday – Friday, 8:30 AM – 6:00 PM ET.

If you or someone in your family has suffered adverse reactions resulting from a food or drug product, please contact the experienced attorneys at Napoli Bern Ripka, LLP by calling 1-888-529-4669. You may be entitled for compensation for your injury, medical expenses or a loved one’s death.

Originally posted at InjuryBoard by Paul Napoli

FDA Watch List on Potentially Dangerous Pharmaceutical Drugs Recently Updated

Randy Appleton — Sat, 05 Dec 2009 19:50:00 GMT

A list of drugs which may present potential health hazards was recently published by the FDA and can be accessed at the FDA's website. The list includes some antidepressants which have been widely prescribed and may lead to suicidal ideations.

The following are just a few of the drugs that have landed on the FDA’s list:

Prozac, Zoloft, Lexapro, Celexa, Able, Maprotiline, Atomexitine, Bupropion, Ablify

Drugs which are under investigation have been identified as having potential side effects. Physicians who prescribe any medication engage in a balancing approach in which they try to insure the patient receives the intended benefit from the medication without an adverse reaction. If a patient begins to experience an adverse reaction while taking a medication it is important to work with the physician to address the side effects and, if possible, avoid any potential harm.

Many times simple changes in dose or the frequency of taking a medication may relieve side effects while still providing the benefit of the medication. The best source of information describing symptoms which a patient suspects are side effects of any medication is the patient. If a patient suspects they are experiencing an unusual reaction while taking any medication, a full description of the symptoms should be reported to the treating doctor. It may be helpful to make notes describing the symptoms including when they began, how long they lasted and whether any other medication had been taken when the symptoms began. In cases of visible symptoms such as hives or rashes, a photo to show the doctor is a good idea. It is also important that a patient being treated by multiple physicians be sure each physician is aware of all the medication being prescribed by other doctors.

Prescription medications are intended to produce beneficial effects for the patient and should generally be taken specifically as instructed by a doctor. The FDA investigation should warn the public of some risks associated with the medications under investigation. If you, or someone you know, are concerned about the use of any medication, consult with the prescribing physician and discuss your concerns thoroughly. Physicians are concerned about the well being of their patients and such discussions provide an opportunity to address issues which directly deal with a patient's care.

About the Editors: Shapiro, Cooper Lewis & Appleton personal injury law firm is based in Virginia (VA), near the NE North Carolina (NC) border and handles car,truck,railroad, and medical negligence cases and more. Our lawyers proudly edit the Virginia Beach Injuryboard, Norfolk Injuryboard, and Northeast North Carolina Injuryboard as a pro bono public information service. Lawyers licensed in: VA, NC, SC, WV, DC, KY.

Originally posted at InjuryBoard by Randy Appleton

FDA Warns Tyson Foods Of Unsanitary Conditions at Texas Plant

David Mittleman — Fri, 04 Dec 2009 10:30:00 GMT

According to the Food and Drug Administration Tyson Food Group could face legal trouble if it doesn’t clean up its Texas plant that produces seafood soups. In a warning letter posted on the FDA website on Tuesday, U.S. health regulators warned Tyson about the unsanitary conditions of the plant. For example, in September inspectors found fish refrigerated at temperatures that were too high at the Fort Worth plant. In fact, Tyson apparently refrigerated fish between 40-55 degrees for 18 hours at a time—according to FDA regulations, fish should be refrigerated at temperatures below 40 degrees to prevent bacteria and toxins from growing on the meat. Inspectors also cited Tyson for improperly documenting procedures for stopping bacterial growth.

Nevertheless, Tyson argues that the problems have to do with documentation, not actual product safety. The company spokesman, Gary Mickelson, argues that the Fort Worth plant is “clean and sanitary” and that “the products there are safe to eat”. Furthermore, he also maintains that none of the fish that the FDA inspectors discovered was used in the making of any products. Since Tyson received the warning letter in September from the FDA, they argue that they updated their thawing procedures. However, the FDA issued another letter to the company on November 13^th because the agency still believes that Tyson has not fully complied with the regulations concerning pathogen growth and toxins.

According to the Seafood Network Information Center at the University of California-Davis, all meat and seafood should be stored at temperatures below 40 degrees to prevent the growth of pathogens. As temperatures increase, bacteria can multiply and produce enzymes that contribute to food spoilage. Furthermore, shellfish accounts for 3% of food-borne illness cases in the U.S. One-third of food-borne illnesses are caused by improperly refrigerated seafood products that develop a toxin called scroboid poisoning.

Originally posted at InjuryBoard by David Mittleman

FDA Trying to Reduce Preventable Medical Error from Prescription and Over the Counter Drug Use

David Mittleman — Sun, 29 Nov 2009 10:39:08 GMT

Over 3 billion prescriptions are written annually in the United States, and tens of millions of people rely on prescription and over-the-counter (OTC) drugs to sustain their health. With such high numbers of drugs being used, the risk of preventable medical error from improper drug combination or the misuse of medication has led the Food and Drug Administration (FDA) to start the Safe Use Initiative.

As my Virginia-based colleague Greg Webb noted, the initiative calls upon doctors, health care professionals, and even patients to help the FDA identify specific, preventable medication risks and develop interventions to such risks. The initiative has a goal to implement some interventions within the first 12 months of the Initiative's existence.

Among the target groups the Initiative seeks to protect is children. One study cited by the FDA found that over 9,000 children were exposed to prescription opioid drugs from 2003 to 2006. Just as startling was the fact that 60,000 emergency room visits occur annually as a result of unsupervised ingestion of medication by children under the age of 12.

Some of the changes consumers can expect will be better information of the prescription and OTC drugs they take, including the proper dosage to take along with calibrated spoons or cups that are easier to read and correspond with the product's packaging.

Originally posted at InjuryBoard by David Mittleman

New Proposal to Examine Drug Safety

Carrie Strasser — Wed, 25 Nov 2009 09:54:22 GMT

Yesterday, the New York Times reported that a new plan to monitor the safety of drugs could identify a particular drug's risks long before they might have otherwise been discovered. The study that devised this plan was published Monday in the Archives of Internal Medicine.

The authors propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug’s harms and benefits.

This database would be constantly updated as the results of studies were published. This could allow a "real-time" analysis of the various risks and benefits associated with certain drugs.

Dr. Joseph Ross is the lead author of the study and proposed this plan as a new model for post-market surveillance of drugs. Dr. Ross's study used Vioxx as an example and determined that Merck could have discovered the cardiovascular risks of Vioxx many years before it took the drug off the market in 2004.

Merck questioned the methods used by Dr. Ross and his colleagues in the study, stating that the categories used were too broad and included patients who suffered heart attacks after they had stopped taking Vioxx.

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, stated that the type of cumulative analysis proposed by Dr. Ross's study requires an act of Congress. Although the FDA has increased its efforts to ensure drug safety in the past few years, critics call for Congress to grant the FDA more power and resources in order to provide detailed information to patients and doctors.

“There is this kind of dogma in medicine that you shouldn’t use any drug for the first seven years after it’s released, because it takes that long to figure out its harms and benefits,” said Dr. Michael Steinman, an assistant professor of medicine at the medical school of the University of California, San Francisco.

While there are many proponents of the study and its potential to identify drug dangers even faster, some say the number of drugs on the market today would make it nearly impossible, and perhaps too expensive, to cumulatively track every single one of them.

For more information on the FDA and prescription drugs, click here.

To read the study, click here.

Originally posted at InjuryBoard by Carrie Strasser

Another Yaz Birth Control Victim

Paul Kiesel — Tue, 24 Nov 2009 17:58:21 GMT

From Business Wire:

NEW YORK -- Wendy R. Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP announced that Mae Walker today filed a personal injury lawsuit against Bayer Healthcare Pharmaceuticals, Inc., for severe and lasting injuries caused by Bayer’s birth control drug Yaz. Walker’s complaint charges that Yaz is a dangerous prescription drug sold without adequate warnings about the risk of serious injuries.

Walker, age 30, of Belpre, Ohio, works 40 hours a week at McDonald’s and is the mother of three young children. Approximately one year after she started taking Yaz, Walker was diagnosed with deep vein thrombosis (“DVT”), more commonly known as a blood clot, in her left leg. If left untreated, blood clots in the leg can break off and result in life-threatening conditions. Walker was hospitalized for three days, where she received anti-coagulation medication to reduce the swelling in her leg and treat the blood clot.

“Yaz has had a devastating impact on my health and family,” Walker stated. “My work requires me to stand on my feet all day. I still experience leg swelling and cannot lift heavy items. I have to be extremely careful not to ever cut myself due to the blood-thinning medication I am taking, which I have been told I must likely take the rest of my life.”

The complaint charges that Walker would never have developed DVT, been hospitalized, or forced to undergo numerous medical tests and procedures, had Bayer properly warned patients of the dangers of using Yaz.

“The FDA’s adverse event database for Yaz and Yasmin reveal a very high number of serious adverse events associated with these drugs, including strokes, heart attacks, blood clot formation, gallbladder and kidney disease, and sometimes death,” commented attorney Fleishman. “Bayer failed to warn doctors and consumers that Yaz and Yasmin are actually more dangerous than previous generations of oral contraception pills.”

The complaint was filed in the Superior Court of New Jersey, where Bayer Healthcare Pharmaceuticals, Inc., is located.

Click here for the rest of the article.

**Also, anyone who has been adversely affected due to taking these prescription drugs, like Yasmin, Yaz or Ocella, should get in touch with Helen Zukin. Ms. Zukin recently retained a client, a young woman, who unfortunately suffered from a stroke, after only taking Ocella (generic version of Yaz) for a month.

Originally posted at InjuryBoard by Paul Kiesel

FDA Starts Safety Review Of Weight Loss Drug Meridia

Greg Jones — Tue, 24 Nov 2009 09:25:09 GMT

The U.S. Food and Drug Administration has begun an expedited safety review of sibutramine based on a recent study showing that some patients have a higher rate of heart attacks, strokes and other cardiovascular events after taking the weight loss drug. Abbott Laboratories markets sibutramine as the popular weight loss drug Meridia.

Although the FDA has not made any conclusions, it is studying the initial data from a six-year study referred to a s the SCOUT study which examined the effects of the drug on overweight or obese subjects at risk of a cardiovascular event.

The SCOUT study results demonstrate the need for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke to avoid using sibutramine or Meridia.

The SCOUT data looked at roughly 10,000 patients who were at least 55, overweight or obese and had a history or heart disease or type 2 diabetes as well as at least one other cardiovascular risk factor. The study did not include those who had recently suffered a heart attack or stroke. The study was designed to demonstrate that weight loss achieved through sibutramine and "standard care" lowered the number of cardiovascular events more effectively than weight loss reached through a placebo and standard care.

The FDA said it "understands the serious nature of the preliminary data" and vowed to share its conclusions with the public as soon as it finishes its expedited safety review.

Originally posted at InjuryBoard by Greg Jones

Brooklyn's BEST Smoked Nova Salmon Recalled Due to Potentially Deadly Bacterium

Paul Napoli — Sun, 22 Nov 2009 09:10:30 GMT

November 20, 2009

Service Smoked Fish Corp. of Brooklyn, NY, is recalling specific "Use-By" dates and lot codes of Brooklyn's BEST brand Smoked Nova Salmon because they have the potential to be contaminated with the organism Listeria monocytogenes.

The U.S. Food and Drug Administration (FDA) found Listeria monocytogenes in samplings of finished products, prompting this recall. Service Smoked Fish Corp. has ceased production and distribution of the product while the company and the FDA investigate the cause of the contamination. No illnesses have been reported to date.

Brooklyn’s BEST brand Smoked Nova Salmon was distributed in the greater New York area, New Jersey, Connecticut and the areas of Baltimore, MD, Los Angeles, CA, and Portland, OR. Consumers may have purchased the product from retail food stores.

The Smoked Nova Salmon was vacuum-packed in clear, plastic bags of various size packages including 3 oz., 4 oz., 8 oz., 12 oz., 16 oz. and random weight sides with the brand name "Brooklyn's BEST" appearing on a circular label inside the vacuum bag. A "Use-By" date appears on the bottom of the gold board. Units with "Use-By" dates of 12/03/09 through 12/19/09 are being recalled. The product was also air-packed in bulk boxes. Air-packed units with lot numbers 060 through 043 are being recalled. No other use-by dates or lots numbers are involved in this recall.

Listeriosis, a serious and sometimes fatal infection caused by eating food contaminated with the bacterium Listeria monocytogenes, is recognized as an important public health problem in the United States. People suffering from listeriosis may suffer gastrointestinal symptoms such as nausea, vomiting and diarrhea. The most serious manifestations of listeriosis include septicemia, meningitis (or meningoencephalitis), encephalitis, and intrauterine or cervical infections in pregnant women, which may result in spontaneous abortion or stillbirth. These disorders are usually preceded by influenza-like symptoms including persistent fever.

While healthy people may also be at risk, people most susceptible to the disease are children, frail or elderly people, pregnant women and people with immune systems weakened by corticosteroids, anticancer drugs, graft suppression therapy or AIDS.

L. monocytogenes has been associated with such foods as raw milk, supposedly pasteurized fluid milk, cheeses (particularly soft-ripened varieties), ice cream, raw vegetables, fermented raw-meat sausages, raw and cooked poultry, raw meats (all types) and raw and smoked fish. It is quite hardy and resists the deleterious effects of freezing, drying and heat and its ability to grow at temperatures as low as 3°C permits multiplication in refrigerated foods.

Listeriosis has an extremely variable incubation period. It can range from three to 70 days, but symptoms usually appear within a month. Specific laboratory tests are the only way to identify this disease. People who are experiencing symptoms and fear they may have contracted Listeriosis, especially those people most at risk, should contact their physician.

Consumers who have purchased the above "Use-By" dates or lot codes of Brooklyn's BEST brand Smoked Nova Salmon are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 718-388-4067, Monday - Friday, 7 am - 3 pm.

Originally posted at InjuryBoard by Paul Napoli

Food Allergies Increasing Dramatically in Children

Paul Napoli — Sun, 22 Nov 2009 09:01:39 GMT

November 18, 2009

In a new study by researchers of the National Center for Health Statistics, food allergies in U.S. children under age 18 years increased dramatically by 18 percent between 1997 and 2007.

"People are more aware of food allergies today, and that could have something to do with it," said study author, Amy Branum. "But, when we looked at health-care surveys filled out by parents and those from the health-care sector, we saw the increase across the surveys so this may be more than just increased awareness."

The authors of the study, Amy M. Branum, MSPH and Susan L. Lukacs, MSPH, DO are with the Centers for Disease Control and Prevention's National Center for Health Statistics, Office of Analysis and Epidemiology, Infant, Child, and Women's Health Statistics Branch. Results of the study were published online November 16 and will appear in the December print issue of Pediatrics.

The study defined food allergy as a potentially serious immune response to eating specific foods or food additives. Eight types of food accounted for over 90% of allergic reactions in affected individuals: milk, eggs, peanuts, tree nuts, fish, shellfish, soy and wheat. Reactions to these foods by an allergic person can range from a tingling sensation around the mouth and lips and hives to death, depending on the severity of the allergy.

Other notable study findings:

· Four of every 100 children have a food allergy. In 2007, an estimated 3 million children under age 18 years (3.9%) had a reported food allergy.

· Children with food allergy are more likely to have asthma or other allergic conditions. In 2007, 29% of children with food allergy also had reported asthma compared with 12% of children without food allergy.

· Recent data show hospitalizations with diagnoses related to food allergies have increased among children. From 2004 to 2006, there was an average of 9,537 hospital discharges per year with a diagnosis related to food allergy among children 0 to 17 years.

"People should be aware that food allergy may really be increasing," Branum said. "If small children have symptoms when they eat a particular food, have that child checked out, particularly if they have co-occurring conditions like asthma and eczema."

Because food allergies can range from merely irritating to life threatening, the U.S. Food and Drug Administration (FDA) works to ensure that major allergenic ingredients in food are accurately labeled. The FDA, in cooperation with food manufacturers, issues recall notices on its website at http://www.fda.gov/Safety/Recalls/default.htm when a food product is found to contain allergens undeclared on the label and needs to be recalled for public safety. There have been five food product recalls so far this month and eleven last month in October due to undeclared allergens.

When a product causes serious injury or death, it is important to contact a personal injury attorney who has experience in handling product liability cases. Products liability is the branch of law that deals with the liability of parties involved in the manufacturing of a product for any damages caused by the product. If you or a loved one suffered an allergic reaction due to milk, eggs, peanuts, tree nuts, fish, shellfish, soy or wheat as the result of undeclared allergens on the food product label, call Napoli Bern Ripka LLP today at 888-529-4669 to discuss your case and determine if you are entitled to compensation for your injuries or a loved one’s wrongful death.

Originally posted at InjuryBoard by Paul Napoli

New FDA Initiative Seeks To Decrease Drug Dosage Errors

Greg Webb — Sun, 22 Nov 2009 08:52:53 GMT

In an attempt to curb the number of serious deaths and illnesses caused by misuse of medication, the Food and Drug Administration (FDA) is attempting to identify the most serious threats and find ways to avoid them through their Safe Use Initiative. The FDA called on doctors, other healthcare professionals and consumers in order to gain information about which drugs and circumstances may be particular problems; they will also be calling public hearings as well.

One of the main issues the FDA has identified is the overuse of acetaminophen, a pain reliever that can cause liver damage if taken in excess; because the drug is used in so many different medications, it is hard for the consumer to know how much he or she is taking. The FDA will also investigate information given to patients, such as labels, package inserts and directions that pharmacists use when distributing prescriptions. Such an investigation is long overdue since about 99.5% of pamphlets contain unregulated information that is missing critical information.

According to a 2007 study conducted by the Institute of Medicine, about 1.5 million preventable “drug accident events” occur annually in the United States; aside from the toll on health, this costs an estimated $4 billion each year as well. FDA officials acknowledged they do not have these hard figures since the term "preventable harm" encompasses a range of poorly tracked activities including accidental overdoses, distributing the wrong medication or the wrong dosage, abuse of medication and drug-quality defects; medication errors do not contain common side-effects.

This writer thinks this is a good initiative. One wonders how many incidents there are per year of unintended “misuse” of medications, through lack of education or information about the particular drug at issue. Many people overuse over-the-counter pain medications because they cannot afford prescription strength drugs.

Originally posted at InjuryBoard by Greg Webb