DC Metro Area Medical Malpractice Law Blog

A new study has confirmed that hospital patients given Trasylol (aprotinin), a drug used to reduce bleeding during heart surgery, are 53% more likely to die than patients who are given other anti-bleeding drugs.  The drug's manufacturer, Bayer AG, has informed the U.S. Food and Drug Administration (FDA) that it has begun removing all remaining stock of Trasylol from all pharmacies and health care facilities in the U.S.

The latest Trasylol study was released Wednesday is slated to appear in print in the May 29 issue of the New England Journal of Medicine.

Laser eye surgeries such as LASIK (Laser-Assisted In Situ Keratomileusis) are quickly becoming some of the most common and technologically sophisticated procedures available for correcting relatively minor vision problems.  Generally performed on an out-patient basis with the aid of only anesthetic eye drops, LASIK procedures are usually quick and easy, and the results are often remarkable.  Unfortunately, however, the results can be underwhelming, too -- and occasionally even catastrophic. 

To help clear up some misconceptions and misinformation regarding LASIK procedures, and to help consumers better understand the risks of laser eye surgeries, the U.S. Food and Drug Administration (FDA) has established a web page devoted specifically to patient education.  According to the agency, there are a few categories of people who should think twice before they attempt to resolve their vision problems with LASIK surgery.

The U.S. Food and Drug Administration (FDA) has announced that some flavors of the dietary supplements "Total Body Formula" and "Total Body Mega Formula" have been found to contain dangerously high levels of selenium -- a naturally-occurring mineral that is toxic in high doses.  The sole distributer of the product, Total Body Essential Nutrition, Inc., has issued a voluntary recall. 

New U.S. Food and Drug Administration (FDA) guidelines for oversight of "off-label" drug use -- still in draft form and unfinalized -- could allow pharmaceutical companies to market more drugs for unapproved uses.  The proposed guidelines are a step in the wrong direction according to Dr. Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center.  His concern for patient safety was articulated in a recent edition of the New England Journal of Medicine.

The U.S. Food and Drug Administration (FDA) has announced that it is working with Merck, Inc., the pharmaceutical company, to explore a possible link between the popular asthma and allergy drug Singulair (known generically as montelukast) and behavioral changes, mood changes, and increased rates of suicide among users.  The investigation could take nine months, and although the agency is not yet recommending that anyone stop taking the drug, it is asking health care professionals to monitor Singulair patients for changes in condition that may indicate a suicide risk.

Neupro (rotigotine), the first skin patch approved to treat symptoms of Parkinson's disease in the U.S. in 2007, is being recalled by the FDA.   Physicians have been advised to not start  new patients on the transdermal patch and to begin tapering down patients who are currently using the patch.  After the end of April, Neupro will not be available in the United States.   Neupro is being recalled because of formation of rotigotine crystals that can form on the patches, thus altering the amount of medication that can be absorbed through the skin.  

For further details, please call the company's toll-free information number: 800-477-7877.

Please contact your doctor for further advice regarding Neupro's recall.

Body art (including practices like tattooing and piercing) is a popular form of self-expression.  These permanent markings are typically created by professional artists, but the health and safety regulations they must follow vary according to the city, county or state regulations under which they practice.   Furthermore, certain aspects of body art, such as tattooing, entail unavoidable health risks, such as exposure to inks and dyes that have never been approved by the U.S. Food and Drug Administration (FDA) for use on human skin.  Some of those inks have also been known to react badly when exposed to diagnostic magnetic resonance imaging (MRI) scans.

Spiriva, a pulmonary drug marketed by Pfizer and Boehringer Ingelheim Pharmaceutical, appears to increase the risk of stroke, according to a public warning from the the  U.S. Food and Drug Administration (FDA).  Though a comprehensive assessment of the drug's safety is not yet complete, a potential for adverse events has prompted the agency to issue a warning, to assist patients and physicians in identifying any potential problems immediately.

According to the U.S. Food and Drug Administration (FDA), Baxter Healthcare Corp. has announced that it is recalling all remaining multi-dose vials of their heparin, as well as single-dose vials and Hep-Lock heparin flush products, which prevent blood clots in intravenous (IV) lines.  Baxter widened its initial recall after another manufacturer of multi-dose heparin vials -- APP Pharmaceuticals of Schaumburg, Ill. -- was able to assure the FDA that it could meet the demand for the entire supply of the blood thinner in the United States.  Several U.S. manufacturers produce items similar to Baxter's Hep-Lock.

Some over-the-counter dietary supplements have been found to contain hormonal ingredients that speed up the development of colon cancer and also make important cancer-treating drugs less effective.  The finding is the result of recent research conducted at the University of Texas Southwestern Medical Center and published in a recent edition of Clinical Cancer Research.

Many over-the-counter Icy Hot therapy products have been voluntarily recalled by Chattem, Inc., according to a recent announcement by the U.S. Food and Drug Administration (FDA).  According to the agency, customers suffered first, second and third degree burns, skin irritation and skin removal due to their use of the Icy Hot Heat Therapy Air Activated Heat patch.

The U.S. Food and Drug Administration (FDA) is warning that three products:  Botox, Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B) have been linked to fatal adverse reactions including respiratory failure.  The most severe adverse reactions have occurred in children with cerebral palsy, who rely on the drug for treatment of limb spasticity.  The FDA warns that it has not approved any Botulinum toxins for treatment of spasticity in either children or adults, though it is not advising healthcare professionals to stop prescribing the products at this time. 

Each year more than 7,000 children 11 years of age or younger visit hospital emergency rooms due to incidents involving over-the-counter cough and cold medications.  Two-thirds of those incidents involve kids taking the medications without adult supervision.  The findings are the result of recent research published in the journal Pediatrics, the official journal of the American Academy of Pediatrics.

The FDA recently announced that no OTC cough and cold products are safe for children under the age of two years.   Studies are on-going for children between the ages of two and eleven.   The FDA announcement is reproduced in its entirety below. 

Public Health Advisory

Nonprescription Cough and Cold Medicine Use in Children

FDA Recommends that Over-the-Counter (OTC) Cough and Cold Productsnot be used for Infants and Children under 2 Years of Age

"FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age.  FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.

FDA’s recommendation is based on both the review of the information we received about serious side effects in children and the discussion and recommendations made at the October 18–19, 2007, public advisory committee meeting at which this issue was discussed.  FDA strongly supports the actions taken by many pharmaceutical manufacturers to voluntarily withdraw cough and cold medicines that were being sold for use in this age group. 

FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age.  We are aware of reports of serious side effects from cough and cold medicines in children 2 years of age and older.  FDA is committed to completing its comprehensive and thorough review of the safety of OTC cough and cold medicines in children 2 years of age and older as quickly as possible and expects to communicate our recommendations to the public in the near future. 

Pending completion of FDA’s ongoing review, if parents and caregivers use OTC cough and cold medicines in children 2 years of age and older, FDA recommends:

• Checking the “active ingredients” section of the DRUG FACTS label.  This will help you understand what “active ingredients” are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one “active ingredient” (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
  
  
• Being very careful if you are giving more than one OTC cough and cold medicine to a child.  Many OTC cough and cold medicines have more than one “active ingredient.”  If you use two medicines that have the same or similar “active ingredients” a child could get too much of an ingredient which may hurt your child. For example, do not give a child more than one medicine that has an antihistamine.
  
  
• Carefully following the directions in the DRUG FACTS part of the label.  These directions tell you how much medicine to give and how often you can give it.

• Only using the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.
  
  
• Choosing OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of the reach of children.
  
  
• Understanding that using OTC cough and cold medicines are intended only to treat your child’s symptom(s).  OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick.  They only relieve symptoms and make your child feel more comfortable.
  
  
• Not using these products to sedate your child or make children sleepy.
  
  
• Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older. "
  

Merck & Co., Inc. has announced a voluntary recall of two of its Haemophilus influenza type b (Hib) vaccines, PedvaxHIB® (monovalent Hib vaccine) and COMVAX® (Hib/hepatitis B vaccine), and won't resume distribution until the fourth quarter of 2008.  The U.S. Centers for Disease Control (CDC) is warning that as a result, pharmaceutical manufacturers likely will not be able to provide adequate Hib vaccine to inoculate all children for whom the vaccine is recommended during the following year.

Pharmaceutical companies spend an average of $21 billion per year advertising prescription drugs, and most of that is directed at physicians, physicians-in-training and medical students.  Whether medical schools facilitate or discourage their students' exposure to pharmaceutical advertising significantly impacts the way physicians will later view drug companies, according to a new study published in the Journal Pediatrics, the official journal of the American Academy of Pediatrics (AAP).

Cardiologists are growing increasingly suspicious over the hesitation of drug makers to release the results of clinical trials for the cholesterol-lowering drugs Vytorin and Zetia, according to a recent New York Times article.  The two drugs are prescribed for an estimated 800,000 Americans every week, generating sales of $4 billion in 2007 alone.  Clinical trials of the drugs ended two years ago, but manufacturers Merck and Schering-Plough have yet to release those research results.

According to a safety review by FDA experts, the flu drugs Tamiflu and Relenza should carry a package warning label about possible dangerous psychiatric side effects in children. Tamiflu was approved by the FDA for pediatric use for children under 12 in 2005.  

Safety concerns became evident two years ago after Japanese reports of 25 deaths and 32 incidents of psychiatric problems in children after taking Tamiflu.  Following reports of children experiencing "neuropsychiatric events," to include delirium, delusions, hallucinations, impulsive behavior and self-injury, new studies of the drug were initiated. Tamiflu is available in pill and syrup form, and is used to treat symptoms of seasonal influenza. 

On Tuesday, November 27, 2007, the FDA's Pediatric Advisory Panel will review the data and determine whether to issue new warning labels for Tamiflu and Relenza.  According to the FDA documents, the problems usually occur within 24 hours of first taking the medication, and usually among patients younger than 21.  FDA documents indicate, "In the remaining reports of delirium with impulsive behavior and self-injury, patients were attempting to flee or escape from windows or balconies and were unsuccessful in their efforts. In addition, there were a few patients who became aggressive or violent and/or performed acts that were injurious to themselves (e.g. banging head against wall) or others (e.g. child tried to strangle mother)."

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals recently seized  more than 12,000 tubes of cosmetic eyelash product worth approximately $2 million, because the product contained undeclared bimatoprost -- a prescription drug ingredient used in the treatment of increased eye pressure.

Bayer Schering Pharma, the manufacturer of popular heart surgery drug Trasylol, will suspend all marketing of the drug until a review can be conducted of recent Canadian research which has implicated the drug in a higher risk of death for cardiac patients. 

The U.S. Food and Drug Administration (FDA) and pharmaceutical manufacturer, Cephalon, have notified physicians of a change to the warning which accompanies Provigil -- a drug used in the treatment of narcolepsy and obstructive sleep apnea.  The drug has recently been linked to life-threatening skin infections and other serious hypersensitivity reactions, as well as to adverse psychiatric symptoms, such as anxiety, mania, hallucinations, and suicidal ideation. 

U.S. Marshals recently seized $71,000 worth of dietary supplements at the request of the U.S. Food and Drug Administration (FDA).  The supplements, marketed and distributed by FulLife Natural Options, Inc., of Boca Raton, Florida, had been promoted for the treatment of diabetes, anemia and hypertension, but had never been approved by the FDA, making them unapproved new drugs.  The agency moved to have the supplements seized by federal agents after conducting multiple investigations of FulLife's business practices and issuing warnings regarding the unproven health claims.

A strain of bacteria responsible for ear infections in children has been discovered to be resistant to all eighteen antibiotics approved for pediatric use, according to a recent article in the Journal of the American Medical Association.  Pediatricians discovered the strain by performing a procedure known as tympanocentesis (or an "ear tap"), and analyzing the fluid.  The strain, known by scientists as 19A, can be eradicated only with levofloxacin, an antibiotic approved for use in adults, but which specifically carries a warning against use in children.

The U.S. Food and Drug Administration (FDA) has warned that a type of drug used in heart testing can cause serious cardiopulmonary reactions, and has advised that a Black Box warning should warn against the risk.  Marketed as Definity and Optison, the drugs, classified as micro-bubble ultrasound contrast agents, are used by physicians to get a clearer image of the heart during electrocardiography.  The FDA has warned that these drugs have caused as many as 11 deaths and nearly 200 dangerous adverse reactions, mainly in patients with severe heart conditions.  Adverse reactions typically occur between 1 and 12 hours after administration of the injectable drug.

More than a dozen children's cough and cold medications have been voluntarily recalled by their manufacturers this week in response to mounting safety concerns, according to a Washington Post report.  Fourteen branded, over-the-counter (OTC) cold remedies marketed for use in children under 2 years of age have been pulled from store shelves so far.  The popular drugs have never been approved by the United States Food and Drug Administration (FDA) for use in children.

Fentora, a cancer pain medication, is too frequently misused and improperly prescribed, according to a Public Health Advisory recently issued by the U.S. Food and Drug Administration (FDA).  Manufactured by Cephalon, Inc., Fentora is most commonly prescribed to treat breakthrough pain in terminal cancer patients who have already developed a tolerance to opioid pain medications.  According to the FDA, Fentora-associated deaths have recently occurred in non-cancer patients, and in patients who lacked opioid tolerance, indicating that the drug has been prescribed incorrectly.  Some patients have suffered adverse reactions following a dosage of Fentora that was too high, and some adverse events have occurred after patients took too many doses of the drug.

FDA Medwatch recently reported that some models of the Abbott blood glucose meters that may have been dropped may result in inaccurate or unreadable results.   Patients should perform a meter display check  as instructed in the meter's User Guide.  

Following is the complete MedWatch notification:

"MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Abbott notified users of Precision Xtra, Optium, ReliOn Ultima, Rite Aid, and Kroger blood glucose meters (manufactured after January 31, 2007), to check display screen of the meter to make sure that it is working properly. If meters are dropped onto a hard surface, part of the display can be jarred or disconnected, thereby making it difficult to read the lot number or date information. Additionally, dropping the meter can cause the screen to appear blank, which could result in an inability to view blood glucose test results. The inability to generate blood glucose results may cause a significant risk for hypoglycemia or hyperglycemia.

Users of these meters who note that the display screen is not working properly should immediately stop using their meter. Patients should keep their glucose meters in the wallet provided to offer additional protection for the meter. If the meter is dropped on a hard surface, patients should immediately perform a meter display check. Instructions on how to do this are detailed in the meter's Users Guide. If no problems are encountered during the automatic display check, the meter is ready for use.

Read the complete MedWatch 2007 Safety Summary including a link to Abbott's Press Release at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Glucose

To send a comment or question to the MedWatch program: http://www.fda.gov/medwatch/feedback.htm"

The U.S. Food and Drug Administration (FDA) has warned that children's cold medicines can be deadly if over-used.  According to a recent Public Health Advisory,  serious adverse events recently reported in conjunction with the use of many common, over-the-counter cold remedies appear to be the result of over-medication.  The agency has announced that its Nonprescription Drugs Advisory Committee will meet to discuss the safety and effectiveness of these drugs in October.  In the interim, the agency recommends that parents who administer over-the-counter cold remedies to their children adhere to the following safety guidelines:

Women who are ultra-rapid metabolizers of codeine may inadvertently expose their babies to lethal levels of morphine if they take the drug while breastfeeding.  At least one infant has recently died from a morphine overdose linked to contaminated breast milk -- the mother had been taking codeine for episiotomy pain.  The U.S. Food and Drug Administration (FDA) recently issued a warning related to the potential dangers of the drug for nursing mothers and babies.

Human growth hormone is ineffective at slowing the aging process and may be dangerous, according to a report published earlier this year in the journal Annals of Internal Medicine.  The hormone has been advertised as a revolutionary anti-aging therapy. Initial studies regarding its effectiveness as such seemed to show that it was effective at improving bone density, cholesterol levels and body composition in older adults.  This latest research disproves those claims, however.  Authors of the study are quick to remind that the U.S. Food and Drug Administration has never approved growth hormone for this purpose, and prescribing it as an anti-aging remedy is illegal.

The U.S. Food and Drug Administration (FDA) recently announced its approval of the antipsychotic drug Risperidone (marketed as Risperdal) for the treatment of schizophrenia in adolescents between 13 and 17 years of age, and for the treatment of bipolar I disorder in children and adolescents between the ages of 10 and 17.  It is the first atypical psychiatric drug ever approved to treat these disorders in children, and at least one human interest organization is concerned that the drug's approval came too easily.

Zelnorm (tegaserod maleate), a constipation drug removed from the market earlier this year by the U.S. Food and Drug Administration (FDA) will be made available once again under restricted access guidelines.  Patients and physicians who were left with no alternative treatment options following the agency's ban had appealed to the FDA earlier this year, requesting that it reconsider its position.  The agency banned the marketing and sale of the drug in the U.S. after it was associated with an unacceptably high risk of heart attack, stroke and unstable angina in patients.

The U.S. Food and Drug Administration (FDA) has announced that a black box warning has been placed on the popular diabetes drugs Avandia and Actos (pioglitazone hydrochloride), regarding an increased risk of heart failure among some patients taking the medications.  The drugs treat Type 2 diabetes by decreasing insulin resistance. The warnings will be aimed at physicians who prescribe the drugs, urging them to monitor their patients for dangerous cardiac symptoms.  The drugs had previously been labeled as increasing the risk of heart failure, but a stronger warning label was agreed upon when it became evident that physicians were still prescribing the drug too frequently. 

Safety labels on fifty-four prescription drugs have recently undergone changes that may merit your attention, according to the U.S. Food and Drug Administration (FDA).  Flagged as part of the agency's Safety Information and Adverse Event Reporting Program, the latest labeling changes could alert many patients to health hazards or dangerous situations before they become critical.  The following drugs made changes to the "contraindications" or "warnings" sections of their labeling:

Guidant Heart Defibrillator manufacturer, Boston Scientific, settled about 4,000 patient lawsuits this week for $195 million, according to the New York Times.  Those patients claimed that the corporation neglected to inform them of potential flaws in the heart device -- at least seven people died following malfunctions caused by faulty insulation.  Though Guidant (which was bought by Boston Scientific in 2006), knew that the defibrillators were dangerous, they didn't acknowledge it publicly until 2005, and continued selling the defective products in the interim.  In total, more than 100,000 devices were eventually recalled.  Guidant had held far more than the settlement amount in reserve explicitly to settle lawsuits related to the defibrillator defects.

Previously on the D.C. Metro Area Medical Malpractice Law Blog, we posted an article regarding an earlier Guidant Fraud Settlement.

If you or a family member believes that you have a case involving a defective medical device, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here.

Red yeast rice and red yeast rice supplements are often marketed as cholesterol-lowering alternatives to medication.  The U.S. Food and Drug Administration (FDA) has announced, however, that some red yeast rice products may lower peoples' cholesterol because manufacturers have been illegally lacing them with lovastatin -- the active ingredient in Mevacor, a prescription cholesterol drug.  The FDA has issued warnings related to the following specific red yeast rice products:

• Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively

• Cholestrix, sold by Sunburst Biorganics.

A federal jury in Florida has awarded $5.5 million to the estate of a 28-year-old man who died of an accidental overdose of pain medication because his Duragesic narcotic patches were defective.  The single-use patches which deliver fentanyl, a narcotic, via skin absorption, are manufactured by two Johnson & Johnson subsidiaries.  A jury found the manufacturers guilty of negligence in the manufacture of the patch, and of failing to adequately warn people about its dangers. 

Whole Foods Market has issued a recall of Swiss Dark Chocolate Bars marketed under the 365 Organic Everyday Value label, because they could contain undeclared almonds.  The chocolate bars were sold in stores throughout the U.S., including Maryland, Virginia and the District of Columbia.  According to the U.S. Food and Drug Administration (FDA), the bars affected by the recall have a lot code that begins with the letters "L71423" followed by a time stamp of between the hours of 11:33 and 12:15.  The time stamp can be found on the back of the wrapper.  The recall is only being conducted because the product ingredient label does not include almonds -- a flaw that has been tied to a temporary error in the packaging process.  Customers who purchased the chocolate bars can return them to the store for a full refund, or may call Whole Foods Markets at (512) 542-0656.  According to the Nemours Foundation, sponsor of the popular Kids' Health Organization, some of the earliest signs or symptoms that you're experiencing a nut allergy may include:

A previous recall of Castleberry's Food Company products contaminated with deadly Clostridium botulinum has been expanded significantly to include more than 90 items according to the U.S. Food and Drug Administration.  Many contaminated canned goods are beginning to swell and explode as a result of the bacterial growth.  According to the U.S. Centers for Disease Control (CDC), consumers must be especially careful in handling and disposing of these infected products, preventing any kind of human exposure to their contents.  The agency's website provides the following advice regarding proper disposal:

Several canned products from Castleberry's Food Company may be contaminated with Botulism, and are being voluntarily recalled, according to the U.S. Food and Drug Administration (FDA).  Following is a list of affected products:

• Castleberry's Hot Dog Chili Sauce, 10 oz can (UPC 3030000101)
• Austex Hot Dog Chili Sauce, 10 oz can (UPC 3030099533)
• Kroger Hot Dog Chili Sauce, 10 oz can (UPC 1111083942)
• Morton House Corned Beef Hash, 15 oz can (UPC 7526665830)
• Cattle Drive Chili with Beans, 15 oz can (UPC 3030001515)
• Southern Home Corned Beef Hash, 15 oz can (UPC 0788015360)
• Meijer Corned Beef Hash, 15 oz can (UPC 4125095229)
• Castleberry's Chili with Beans, 15 oz can (UPC 3030001015)
• Castleberry's Barbecue Pork, 10 oz can (UPC 3030000402)
• Bunker Hill Chili No Beans, 10 oz can (UPC 7526604112)
  

The Bayer Ascensia Contour Blood Glucose Monitoring System, Product 7152A, has been recalled by Bayer Healthcare and the U.S. Food and Drug Administration (FDA).  The reason for the recall is that the numeric display reports the wrong units of measure for Canadian users.  According to the recall notice, though the monitors should display results in mmol / L format, they are instead calibrated to display in mg / dL format -- a mistake that could easily lead to mis-management of blood sugar levels, potentially causing hypoglycemia. 

Patients with questions regarding the recall are instructed to call Bayer Healthcare at 1-574-256-3441.

With names like The Mediterranean Diet and The Lemonade Diet among others, "detox diets" -- and their celebrity devotees -- enjoy significant media attention.  Medical and nutrition experts urge caution, however, and advise that detox diets can be particularly dangerous for teens, who need calories and nutrients to support their growth, and for those with diabetes, whose blood glucose levels should remain constant and stable.

Two medical journals this spring have reported that pharmaceutical companies continue to make questionable payments to physicians as incentives to boost drug sales. 

Drugs with identical brand names may contain completely different chemicals -- and treat completely different illnesses -- depending on the country in which they are sold, according to the U.S. Food and Drug Administration (FDA).  The FDA has issued an advisory that although a registry of drug names is maintained in the U.S., and proposed new drug names are compared against it, no organization provides such a safeguard internationally.  As a result, drugs like Flomax, if bought from a U.S. pharmacy, will always treat an enlarged prostate.  Buy Flomax at a pharmacy in Italy, however, and you'll get a pain reliever. 

Ten-ounce bags of Trader Joe's brand diced onions could be contaminated with Listeria monocytogenes, the U.S. Food and Drug Administration has warned.  Gills Onions, LLC is recalling the diced yellow onions after government inspectors detected the organism during a routine inspection.  No illnesses have yet been associated with the onions.   It is thought that shipments of the infected onions were limited to the states of Arizona, California, Nevada, New Mexico, Oregon and Washington. 

Public Citizen, a non-profit public interest organization, has petitioned the U.S. Food and Drug Administration (FDA) to give oral presentations at all advisory committee meetings that involve the presentation of specific products.  According to a recent article published in The Lancet, of the 275 public meetings of the FDA's Human Drug Advisory Committee occurring between 1997 and 2006, 49 included no oral scientific presentation by the agency.  In contrast, drug company representatives made presentations at every meeting but one. 

The U.S. Food and Drug Administration (FDA) has issued a final rule for current good manufacturing processes (CGMPs) for dietary supplements.  The new rule is aimed at ensuring that supplements are free of undeclared active ingredients and impurities.  According to the FDA, if a supplement is now found by inspectors to not contain the exact ingredients claimed by its manufacturer, the agency could officially deem the product adulterated or misbranded, and compel the producer to change its labeling or remove an ingredient.  Alternatively, the agency could seize the product and file a lawsuit, or seek criminal charges against its manufacturer.  The dietary supplement industry has historically faced little regulation.  Some critics maintain that even this new rule doesn't go far enough to protect consumer safety.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.  

Anti-psychotic drugs can be fatal for some elderly patients, according to a new study published in the Annals of Internal Medicine.  The study included more than 27,000 patients over age 66 who suffered from dementia, and revealed that the use of the drugs in these patients contributes to an increased risk of death. 

An advisory issued by the FDA in 2005 warned that patients who suffered from dementia and who also took atypical anti-psychotics such as Zyprexa, Seroquel, Risperdal, suffered a rate of death 1.6 to 1.7 times higher than similar patients who only took a placebo.  Most of those deaths seemed to be heart-related or linked to infections.  The FDA subsequently requested that manufacturers label these anti-psychotic drugs with appropriate warnings and note that they were not approved for the behavioral treatment of elderly patients with dementia.  Many physicians continue to prescribe them, however.  This new study lends more scientific weight to the idea that these drugs are not appropriate for many elderly patients.  The FDA advises that elderly patients taking the drugs for behavioral reasons should have their treatment plans reviewed by health care professionals. 

The Alzheimer’s Association, a nonprofit voluntary organization addressing Alzheimer’s Disease, notes that the range of appropriate behavioral treatments for dementia consists of both non-drug interventions and prescription medications, and the organization recommends that non-drug interventions be tried first.  The group has also designed the internet-based “Alzheimer’s Association Care Finder,” an interactive guide to educate consumers about recognizing quality Alzheimer’s care, choosing the best care options, and advocating for quality care in residential facilities. 

Discount store toothpaste labeled "Colgate" and sold in 5-ounce tubes is being recalled after it was found to contain diethylene glycol, an ingredient used to make anti-freeze, according to a bulletin issued by the U.S. Food and Drug Administration (FDA).  The product was also found not to contain fluoride. 

The Colgate-Palmolive company denies responsibility for the contamination, noting that the affected toothpaste is counterfeit and that the boxes are marked "Manufactured in South Africa," and feature a number of misspelled words.  Colgate does not import its product from South Africa, and is working closely with the FDA to identify the source of the contaminated product. 

If you suspect you have purchased counterfeit Colgate toothpaste, you are urged to call the Colgate-Palmolive at (800) 468-6502.

If you or a family member believes that you have a case involving a dangerous product, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here. 

The FDA has reported that there are no significant problems in the nation's organ harvesting industry.  The report comes less than a year after the formation of the Human Tissue Task Force, a group charged with evaluating the effectiveness of the agency's tissue regulations. 

Over a period of six months, beginning last October, agents from the FDA's Office of Regulatory Affairs (ORA) inspected 153 major tissue recovery businesses, finding no major inaccuracies or deficiencies that would jeopardize the public health. 

Safety problems in the industry have been exposed by a series of recent scandals, the largest involving Biomedical Tissue Services of New Jersey.  The operator of that company has been charged with stealing corpses and unlawfully dissecting them to sell organs.  Many funeral home directors have already plead guilty to crimes involving the company. 

All recent organ harvesting scandals have involved businesses which lacked accreditation by the American Association of Tissue Banks, an organization that imposes more stringent safety standards than the FDA requires.  Membership in the organization is strictly voluntary, however.  The FDA requires no accreditation of tissue handling businesses.

We have posted articles about the lax inspection of transplant organs previously on the DC Metro Medical Malpractice Blog.

If you or a family member believe that you have a case involving inappropriate organ transplantation or medical malpractice, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here.

According to MedWatch - The FDA Safety Information and Adverse Event Reporting Program, Similac Special Care 24 Cal/fl.oz Ready to Feed Premature Infant Formula With Iron has been recalled because the product contains less iron than is stated on the label.  The following alert was distributed by MedWatch on May 29, 2007. 

"Abbott informed consumers and healthcare professionals of a nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital.  The three lots of formula were recalled because they do not contain as much iron as indicated on the label.  The formula was distributed in the United States between November 2006 and May 2007.  Premature infants fed this formula for more than a month after discharge could have an increased risk of developing anemia due to insufficient iron intake.  If parents have concerns about their baby's health, they should contact their baby's doctor or healthcare professional.  No other liquid or powdered Similac Infant formulas were affected. See the attached manufacturer's news release for a list of stock code and lot numbers for formula affected by this recall. "

The complete news release by the manufacturer of Similac products, Abbot's Ross Products Division, is also available at the FDA website.  Ross will replace the recalled product  free of charge to consumers who contact the company at 1-888-899-9182.

Parents with concerns about their baby's health should contact their healthcare professional immediately for alternatives. 

Contact lens wearers should immediately stop using Complete MoisturePlus Multi Purpose Solution and discard all partially-used or unopened bottles.  Reports of a rare and extremely serious eye infection have been linked to the solution.  The infection, Acanthamoeba keratitis, is caused by a parasite and may lead to vision loss with some patients requiring a corneal transplant.  Normally healthy people who wear contact lenses may be affected by the parasite.  During a recent investigation by the Centers for Disease Control (CDC), users of the Complete MoisturePlus Multi Purpose Solution were at least seven times more likely to develop Acanthamoeba keratitis than those who used another brand.

According to an announcement by the director of the Center for Devices and Radiological Health of U.S. Food and Drug Administration(FDA), the manufacturer of the product, Advanced Medical Optics,  "acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health.  FDA and CDC are working closely with the company to collect additional information and we will continue to  alert consumers and advise them as more information becomes available."

Consumers should consult with their doctors about alternative cleansing/disinfecting products.  If they have any symptoms of eye infection, they should seek immediate medical attention.  Early detection is critical for effective treatment of Acanthamoeba keratitis.