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.

The 2008 edition of the schedule of recommended immunizations for people 18 years of age and younger has been posted by the Advisory Committee on Immunization Practices (ACIP) -- a division of the U.S. Centers for Disease Control and Prevention (CDC).  The advisory committee releases new recommendations annually to reflect changes in vaccine formulations and current recommendations for the use of licensed vaccines. 

This summer, don't wait until the last few busy weeks before fall school registration begins to make your child's vaccination appointment -- schedule an appointment now, and enjoy a safer summer. 

Changes from the 2007 immunization schedule are as follows:

Despite the rising costs of fuel this year, millions of Americans will be hitting the nation's roads and airports for a summer vacation -- and for those who suffer from seasonal allergies, summer traveling can pose some unique challenges.  The American Academy of Allergy, Asthma & Immunology (AAAAI), reminds travelers that the climate of your destination, rather than your home, determines the pollens and molds to which you'll be exposed on vacation, and that all seasonal allergy sufferers should take time to plan their clothing and needed medications appropriately. 

The academy offers the following additional allergy management tips for summer vacationers:

New hemoglobin-based artificial blood -- still unapproved for use in the U.S., but heavily studied -- appears to raise a patient's risk of heart attack and death according to an exhaustive review of clinical research data.  This latest research was published in a recent edition of the Journal of the American Medical Association (JAMA).  The findings have spurred critics to allege that the U.S. Food and Drug Administration (FDA) put clinical trial participants in imminent danger by failing to detect or act on research data illustrating significant increases in the rates of heart attack and death reported in trials of these blood substitutes.

The American Heart Association has issued new pediatric recommendations that call for heart fitness screenings prior to stimulant treatment for all children diagnosed with attention-deficit hyperactivity disorder (ADHD).  The new patient safety guidelines were published in a recent issue of the journal Circulation -- official journal of the American Heart Association -- and they address growing fears that stimulant medications can cause serious heart complications in children with underlying, undiagnosed heart disease.

Human Papillomavirus (HPV) -- the sexually-transmitted virus responsible for cervical cancer in thousands of women -- has now been implicated in a rapidly increasing rate of mouth and throat cancers among young men.  Researchers are hoping that a recently-approved HPV vaccine will soon be approved for boys, and tested for its effectiveness in preventing head and neck cancers.  A news article in a recent edition of the Baltimore Sun features Dr. Maura Gillison, an oncologist at Johns Hopkins University's Sidney Kimmel Comprehensive Cancer Center, whose research has been credited with linking the virus and tumors.

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. 

This year's flu season was worse that the previous three, partly because the flu vaccine didn't effectively defend people against the viruses that made them sick, according to the U.S. Centers for Disease Control and Prevention (CDC).  The flu season started slowly this year, peaked in February, and seems to finally be declining.

A Mumps comeback in the U.S. in 2006 was alarming in its severity, and the disease may now take several years to completely eradicate, according to federal public health experts.  Interestingly, the viral outbreak occurred despite the routine administration of a second dose of a mumps vaccine throughout the early 1990s.  These findings were reported in a recent edition of the New England Journal of Medicine (NEJM).  Among other data presented in the article is the fact that 84% of people between 18 and 24 years of age who contracted Mumps during the outbreak had already been given the second recommended dose of MMR vaccine -- a dose that should have protected them from Mumps.

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.

Patient safety errors resulted in 238,337 potentially preventable deaths of U.S. Medicare patients and drove up the cost of the Medicare program by $8.8 billion from 2004 to 2006, according to the 5th Annual Patient Safety in American Hospitals Study.

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.

Adverse drug events affect about 7% of U.S. children in hospitals -- adverse events such as getting the wrong medication, the wrong doses of medication, and dangerous, preventable reactions.  The percentage is much higher than previous estimates, too, underscoring growing concerns about medical errors involving hospitalized children, according to new research published in the journal Pediatrics.

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.

A complex assortment of pharmaceutical drugs has been found in the drinking water supplies of tens of millions of Americans, according to a recent Associated Press investigation.  The contamination affects the drinking water supplies of at least 24 major metropolitan areas across the U.S., including the DC Metro area.

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.

Nearly 10% of U.S. military personnel deployed to Afghanistan are not suitable candidates for mefloquine, an anti-malaria drug commonly administered by the military.  The drug is also known by its trade name Lariam.  The finding is the result of research published in a recent edition of Malaria Journal. 

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.

An industry-wide culture of long hours, speedy service and staffing shortages contributes to millions of potentially serious medication errors in pharmacies across the United States, according to a recent investigative article by USA Today.

A new study conducted at Seattle Children's Hospital indicates that many children hosptalized with influenza have had a recent prior hospitalization that would have provided an opportunity to receive the flu vaccine.  Complete results of the study appear in a recent issue of Pediatrics, the official journal of the American Academy of Pediatrics.

According to a recent article in the Washington Post, an error at the U.S. Food and Drug Administration (FDA) has resulted in the approval of the wrong Chinese drug manufacturing facility.  That error may be partly to blame for approximately 350 adverse reactions and 4 potential fatalities which have been linked to Heparin manufactured by Baxter Healthcare Corporation.  Heparin is a powerful blood thinner.  According to the Post, it now appears that the corporation manufactured its product with pharmaceutical ingredients imported from a Chinese manufacturer that accidentally escaped FDA inspection and approval.

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. 

The pharmaceutical industry has made nurses "soft targets" for drug marketing purposes, but nursing education still does little to teach nurses to recognize and question pharmaceutical industry bias in marketing literature or sales tactics.  The finding is the result of a scientific review of nursing literature recently published in PLoS Medicine, a peer-reviewed medical journal published by the Public Library of Science.

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.

According to a recent study of more than 800,000 seniors, patients receiving care from a geriatrician are much more likely to have safe and positive prescription drug outcomes than those receiving care from non-geriatrician specialists or general practitioners.  The study appears in the latest issue of the journal Medical Care, an official journal of the American Public Health Association.

Approximately 36,000 U.S. deaths are attributed to the flu annually, but seeing your physician at the first signs of flu may not be as beneficial as you think -- last year, thousands of primary care physicians prescribed flu drugs that were known to be ineffective.  Furthermore, 88% of the influenza lab tests ordered last year produced false positive results nearly 30% of the time.  The findings are the result of research recently published in the Morbidity and Mortality Weekly Report (MMWR) -- a publication of the U.S. Centers for Disease Control and Prevention (CDC).

A study examining pharmacists' perceptions of drug dispensing errors and their abilities to communicate critical medication information at drive-through windows indicates that many worry about the safety of window service.  This new study was conducted by researchers at Ohio State University and published in the International Journal for Quality in Health Care.

Hundreds of thousands of children in the U.S. face the prospect of a life-threatening asthma attack at a time when they have no health insurance, according to a new study recently published in the journal Ambulatory Pediatrics.

The Institute for Safe Medication Practices (ISMP), a non-profit patient safety organization, has issued an alert that some medications should never be chewed, cut, crushed, or diluted. The group advises all patients to read medication label instructions carefully and to ask pharmacists or physicians specifically how each drug should be taken. The group reports that unfortunately, not all patients read pharmaceutical directions or receive and follow the advice of health providers.

Black and Hispanic patients who make pain-related ER visits are significantly less likely than white patients to receive strong opiate pain medication, according to new research published in the most recent edition of the Journal of the American Medical Association (JAMA).

More than 3 million U.S. adolescents have used over-the-counter cough and cold medications to get high -- a number comparable to those who have used LSD, and higher than the number who have experimented with methamphetamines.  The finding is the result of recent research sponsored by the U.S. Substance Abuse & Mental Health Services Administration (SAMHSA).

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. "
  

Wonder why drug costs are so high?  Contrary to industry claims, U.S. pharmaceutical companies spend almost twice as much on advertising as they do researching and developing new drugs.  The finding is one result of recent research conducted at York University and published in PLoS Medicine -- the peer-reviewed official journal of the Public Library of Science.

Buckwheat honey appears to give children more relief from the symptoms of upper respiratory infection than does the once-popular over-the-counter medication dextromethorphan (DM), or no treatment at all, according to a recent study published in the Archives of Pediatric & Adolescent Medicine.

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)."

Almost 9% of all U.S. kids between the ages of 8 and 15 fit the diagnostic criteria for Attention Deficit Hyperactivity Disorder (ADHD), according to a study recently published in the Archives of Pediatrics & Adolescent Medicine.  The study was designed, in part, to establish a national baseline for the incidence of ADHD, so that changes or fluctuations in the number of diagnoses would not go unnoticed.

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.

Walking, stretching and simple strength training can significantly reduce the symptoms and improve the functional status of women with fibromyalgia, according to a recent study published in the Archives of Internal Medicine.  The benefits of exercise also seem to be significantly enhanced when paired with disease management education. 

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. 

According to the American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association, 3% - 7% of school-age children suffer from Attention Deficit Hyperactive Disorder (ADHD) -- a disease that often leads to failure in school, difficulty in relationships and employment, and even to alcohol and drug abuse.  Still, finding unbiased, dependable literature regarding ADHD treatment options and medications can be difficult. 

The new ADHD Parents Medication Guide is a free, comprehensive reference and treatment guide published by a network of medical professionals and parent advocacy groups with no pharmaceutical funding or editorial support.  The guide can be downloaded at:  www.ParentsMedGuide.org, and is sponsored in part by each of the following organizations:

There is an abundance of medical information on the Internet, but unfortunately, not all of it is accurate.  Previously on the DC Metro Area Medical Malpractice Law Blog, we've highlighted trustworthy sources of medical information on the web.  Distributors of drugs and dietary supplements sometimes use deliberately misleading marketing ploys to sell their products, though, and in those cases, knowing how to evaluate a website, itself, is a good way to safeguard against fraud.

Most medical errors made by young physicians can be blamed on poor judgment, teamwork breakdown, and / or inadequate technical skill, according to a new study recently published in the Archives of Internal Medicine.  The study involved a comprehensive review of the closed medical malpractice claims of 5 major insurance companies, collected from 1984 to 2004. 

The single best way to prevent the flu, according to the U.S. Centers for Disease Control, is to be vaccinated each year.  For those who wonder just how effective the flu vaccine is, however, the agency offers the following questions and answers related to its effectiveness in preventing the flu:

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. 

The Agency for Healthcare Research and Quality (AHRQ), a division of the U.S. Department of Health and Human Services (HHS), recently issued a 10-item advisory for hospitals and healthcare facilities designed to improve patient safety and reduce medical errors.  Though AHRQ primarily supports research designed to assist health administrators and medical personnel, this knowledge of best practices in patient safety can also benefit the public by enabling patients and their families to advocate for safer medical care.  Following are the 10 recommendations, re-posted in their entirety:

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.

Unlabeled gluten in prescription medications can pose critical health risks for patients with celiac disease, yet many patients and healthcare workers are unaware of the potential for harm.  The National Foundation for Celiac Awareness (NFCA) has partnered with the American Society of Health-System Pharmacists (ASHSP) to raise awareness of the issue within the medical community.  According to the NFCA, an estimated 3 million Americans have celiac disease, but only 100,000 are correctly diagnosed.  Celiac disease is an autoimmune digestive disease and the only treatment is a life-long, gluten-free diet -- one containing no wheat, barley, or rye.

Deadly infections caused by MRSA (methicillin-resistant staphylococcus aureus) are more prevalent than has previously been understood, according to a study recently published in the Journal of the American Medical Association.  The virulent, treatment-resistant bacteria has become the most frequent cause of skin and soft tissue infections among patients who visit U.S. hospital emergency rooms, and infection rates are highest among senior citizens, black people, and men.  Previously associated with hospitals and health care centers, authors of the study note that the bacteria is increasing in prevalence in U.S. prisons and schools.  According to a recent Washington Post article, the following DC-area schools have identified school-based cases of MRSA:

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.

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