Michigan Personal Injury Blog - FDA

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

Alcoholic Energy Drinks Come Under FDA Scrutiny

David Mittleman — Mon, 16 Nov 2009 10:02:36 GMT

Alcoholic energy drinks have gained in popularity, particularly among younger drinkers. But now, the drinks, marketed under flashy names like Evil Eye or Max Fury, are coming under the Food and Drug Administration’s scrutiny. The FDA has never approved of the addition of caffeine to alcoholic drinks, but the producers of these beverages claim that their products are safe. Nevertheless, the FDA is concerned that the addition of caffeine can mask the effects of alcohol, potentially leading to more instances of drunk driving, sexual assaults or other destructive behaviors.

The burden of proving that the caffeine-laden alcoholic beverages are safe falls squarely on the shoulders of the manufacturers. In a September 25^th letter to the FDA, a task force, consisting of the attorney generals of several states as well as several other state, city, and territorial law enforcement officials, stated that “there is a strong emerging consensus of scientific opinion that the combination of caffeine and alcohol…poses a serious public health risk”. Ultimately, the goal is to remove the caffeinated alcoholic beverages from the market. Since the FDA received the letter from the task force, they also issued a letter to the manufacturers of caffeinated alcoholic beverages. Manufacturers have 30 days to respond to the FDA.

So far, larger corporations such as Anheuser-Busch have already removed caffeine from their alcoholic energy drinks. However, other smaller companies such as Los-Angeles based Joose Beverage and Portland, Oregon-based Charge Beverages continue to sell alcoholic energy drinks infused with caffeine. The companies could still challenge the FDA’s request by arguing that their products have already been approved by the Alcohol and Tobacco Tax and Trade Bureau.

Originally posted at InjuryBoard by David Mittleman

Qualitest Pharmaceuticals Recalls 250 Million Insulin Syringes

David Mittleman — Thu, 29 Oct 2009 10:00:00 GMT

Qualitest Pharmaceuticals is recalling 250 million Accusure insulin syringes because the needle can detach from the syringe. If the needle does detach, it can become stuck in the insulin vial, get pushed back into the syringe, or get stuck in the skin after an injection.

Thus far, the company has received four complaints related to the needle detaching from the syringe. However, no injuries have been reported as a result of the problem.

The recall includes all syringes, regardless of lot number, that were sold between January 2002 and October 2009 to wholesale and retail pharmacies nationwide and in Puerto Rico. The company has requested that consumers stop using the syringes if they were purchased during the indicated time period and to contact the company with concerns. Furthermore, consumers can report problems associated with the syringes to the Food and Drug Administration.

Originally posted at InjuryBoard by David Mittleman

FDA to Address Complaints Related to LASIK Eye Surgery

David Mittleman — Fri, 16 Oct 2009 10:25:00 GMT

In recent years, LASIK eye surgery has become increasingly popular. In fact, an estimated 6 million patients have undergone the surgery since its inception. While eye surgery advocates cite that 95% of patients are satisfied with the results of the surgery, the Food and Drug Administration has received some complaints. Specifically, the FDA said it received 140 LASIK-related complaints between 1998 and 2006. However, the FDA has not yet taken the time to investigate the reported issues with LASIK, including permanent damage to the eyes such as double vision, dry eyes, and “halos” appearing around objects at night.

But now the FDA says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience adverse side effects. The first phase of the project has already begun, which is sending questionnaires to patients to fill out after receiving the surgery. The second phase includes a clinical trial that will track patients who received the surgery, which will end by 2012. The FDA also sent warning letters out to 17 LASIK recently for failing to adequately report the adverse side effects of LASIK surgery.

LASIK procedures have fallen off in popularity in the last few years with the continuing economic crisis. The procedure is rather pricey, with an estimated cost between $1,500 and $5,000.

Originally posted at InjuryBoard by David Mittleman

Drug Overdoses Overshadow Number of Deaths Caused by Auto Accidents in 15 States

David Mittleman — Sun, 04 Oct 2009 10:00:00 GMT

Prescription and non-prescription painkillers have pulled ahead as the leading cause of death in 15 states. Painkillers are easier to find, apparently so simple to obtain that in some states more people die from overdoses than the number that die in auto accidents.

For the past ten years, auto accidents have caused the most injury-related deaths. Overall, they still do: according to the Centers for Disease Control, in 2006 there were 45,000 auto accident related deaths as compared to 39,000 drug overdose deaths. However, 15 states including Michigan, Massachusetts, New Hampshire, Rhode Island, Connecticut, New York, New Jersey, Maryland, Pennsylvania, Ohio, Utah, Nevada, Oregon, Washington, and Illinois, have more drug deaths than auto accident deaths. Specifically, Michigan had 500 more drug related deaths than auto accident related deaths in 2006.

The CDC found that many drug related deaths were caused by abuse of opiate painkillers such as methadone, Oxycontin, and Vicodin. In fact, according to the CDC’s statistics, 1 in 5 adults and 1 in 10 adolescents are prescribed opiate painkillers each year. Back in February, regulators announced that they were stepping up their efforts to combat opiate painkiller abuse. Particularly, they targeted 24 powerful painkillers and sent letters to 16 drug companies to inform them that their drugs were subject to review by the Food and Drug Administration. Specifically, the FDA is concerned about high-potency painkillers, which can cause serious health problems, including death.

Originally posted at InjuryBoard by David Mittleman

Autistic Teen Dies from Fatal Overdose on Fentanyl Patch

David Mittleman — Wed, 30 Sep 2009 10:00:00 GMT

According to the Food and Drug Administration’s website, abuse of the fentanyl patch has risen in recent years. However, the blame does not lie with drug-abusing patients. Instead, the responsibility rests squarely on the shoulders of doctors who have prescribed the pain relief patch inappropriately. For example, the FDA has warned since 2005 that the fentanyl patch was specifically designed for cancer and other seriously ill patients who have developed a tolerance for opium-derived painkillers. However, the FDA continues to receive reports of life-threatening side effects and deaths in patients who were prescribed the patch for mild pain such as headaches or other occasional physical discomfort.

Sadly, 15-year-old Michael Blankenship, an autistic young man who was unable to speak, was prescribed a fentanyl patch following dental work. He was released to his mother’s home the day of the surgery, and went to bed that night with the fentanyl patch affixed to his body. His dentist claims he had never prescribed such a strong fentanyl painkiller. In fact, the patch released 100 micrograms per hour, the maximum dosage available. The next morning, Tammy Jarbo-Blankenship, Michael’s mother, found Michael dead in his bed.

Since the incident, Tammy has created a memorial fund in her son’s name to help other autistic children with life’s obstacles and to generate public awareness of Autism. Moreover, she has filed a lawsuit against Seattle Children’s Hospital, where the dentist prescribed Michael the fentanyl patch. Tammy also stated that the civil suit is the last chance for her to hold Children’s Hospital accountable for her son’s death.

Originally posted at InjuryBoard by David Mittleman

Neocate Infant Formula Recalled for Containing Improper Amount of Protein

David Mittleman — Tue, 29 Sep 2009 14:19:21 GMT

Nutricia North America, Inc. has recalled one lot of its Neocate infant formula product. The recall affects approximately 3,700 individual cans sold between September 1 and September 11, 2009, and does not affect any other Neocate products.

Immediate risk of injury or other health consequences are not a concern at this time because the products are being recalled for containing a lower-than-normal level of protein. The affected lot contains a discrepancy of .05 grams of protein versus the normal amount in Neocate products. However, some infants that are fed the affected Neocate products for an extended period of time may have nutritional deficits and could therefore experience slower growth.

Nutricia North America, Inc. has informed the Food and Drug Administration of the voluntary recall. Parents, caregivers, and healthcare professionals are urged to check their cans of Neocate for lot #P91877, the affected lot. Furthermore, the company also urges consumers to contact Nutricia with any concerns regarding the recall.

Originally posted at InjuryBoard by David Mittleman

FDA and Roche Warn Parents About Dosage Confusion with Children's Swine Flu Medication

David Mittleman — Sun, 27 Sep 2009 10:00:00 GMT

Taminflu Oral Suspension is but one prescription drug to help treat the swine flu. However, the Food and Drug Administration and Roche, the maker of the drug, are warning parents to be careful when administering the medication to their children.

According to a statement issued on Friday, the syringe that comes with the medication is marked at 30, 45, and 60 milligrams. However, the instructions that were included in the packaging of the product, inform parents to give their child three-fourths of a teaspoon twice a day. The confusion over the correct amount of the medication can lead to over- or under-dosing, both of which could be potentially dangerous.

The problem is that milligrams measure weight, while teaspoons measure volume. Simply stated, the instructions and the syringe give dosage instructions in two entirely different measurement systems. This makes it very difficult for a layperson to know what the correct dosage is, without having to do some very complicated math to get it right.

Roche has apparently sent a warning letter to doctors and pharmacists instructing them to prescribe the oral version of the drug in milligrams. If prescriptions come in teaspoon or in milliliters, both doctors and pharmacists are supposed to provide a properly corresponding measuring device in place of the original syringe. If your child is already sick with swine flu, the last thing you want to do is prolong the illness by not giving them enough medication, or similarly, make it worse by giving them too much.

Originally posted at InjuryBoard by David Mittleman

Tylenol Manufacturer Recalls Children's Liquid Products Potentially Contaminated with Bacteria

David Mittleman — Thu, 24 Sep 2009 09:39:10 GMT

McNeil Consumer Healthcare, the manufacturer of Tylenol, is voluntarily recalling more than 20 types of child and infant liquid products. According to their statement, McNeil stated that it had discovered bacteria in an inactive ingredient in the products manufactured between April and June 2008.

After consulting with the Food and Drug Administration, McNeil initiated the recall on “selected lots” of the products. So far, the recall is complete at the warehouse and retail level. McNeil maintains that products that are already on store shelves have “met all specifications” for safety and that no bacteria has been found on the finished products.

The specific type of bacteria is called Burkholderia cepacia, and can cause adverse effects, particularly in already susceptible patients with compromised immune systems. Please visit the Tylenol website for a full listing of recalled products. McNeil urges parents and caregivers to contact their child’s healthcare provider, should they have concerns.

Originally posted at InjuryBoard by David Mittleman