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FDA and Biogen Idec Issue Drug Safety Alert Concerning Fatal Reactions to Cancer Drug, Zevalin

Biogen Idec, the world’s fourth largest biopharmaceutical company, has notified healthcare professionals of a significant revision to BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS sections of the Prescribing Information for the cancer drug Zevalin.

The alert and warning revision ( describe severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience.

Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.

Similar events have been associated with Rituxan (rituximab), a component of the Zevalin therapeutic regimen according to the senior director of drug safety and risk management for Biogen Idec, in its advisory letter.

The Zevalin “regimen” combines the anti-CD20 monoclonal antibodies Zevalin (ibritumomab tiuxetan) and Rituxan with indium-111- and yttrium-90 labeled radioisotopes. The regimen is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma (NHL), including patients with follicular B-cell NHL that is refractory to Rituxan.
"Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen," reads a boxed warning in the Zevalin package insert. "These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first rituximab infusion."

In September Biogen Idec changed the Zevalin product labeling to include a black-box warning about post-marketing reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis in patients who received the Zevalin therapeutic regimen. Some of the cases resulted in death.

Onset of the reactions was variable; in some cases occurring within only days of administration, while in other cases the reactions occurred at three to four months.

Serious adverse events associated with the use of Zevalin should be reported to Biogen Idec at 1-877-866-4332 or to the FDA’s MedWatch reporting system (1-800-FDA-1088). 

FDA Warns of Potential Problems with Accuracy of Blood Glucose Meters from Abbott Diabetes Care

The Food and Drug Administration (FDA) is notifying health care providers and patients that blood glucose meters made by Abbott Diabetes Care can be accidentally switched from one unit of measurement to another thereby resulting in an inaccurate blood glucose reading.

An inaccurate reading of the meter can lead patients to take the wrong dose of insulin, which could cause high levels of sugar in the blood, known as hyperglycemia. Hyperglycemia can be life-threatening condition and several cases of hyperglycemia have been reported to FDA.

The meters report blood glucose levels in two different measurements milligrams per deciliter, or mg/dL, the U.S. standard, and millimoles per liter, or mmol/L, the foreign standard.

An unintentional switch in measurement may occur when a patient sets the time and date for the meter, or when it is dropped, or even after the replacement of the battery.

Patients in the U.S., therefore, must make sure their meter reading is displayed in the mg/dL format.

Instead of recalling the products, Abbot has issued a global correction and notification to all healthcare professionals and known users about the problem.

All Abbott glucose meters currently being shipped for distribution are locked with the correct unit of measurement.

The affected glucose meters made by Abbott that are sold in the United States are:

FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense, Sof-Tact, Precision Sof-Tact, MediSense, Optium, Precision Sof-Tact meters, and private label brands ReliOn Ultima, Rite Aid, and Kroger blood glucose meters.

Affected glucose meters sold outside of the United States are: Xceed, Liberty, Boots, Xtra Classic, Easy, and SofTrac.

Physicians and consumers who have experienced a problem with any of the affected glucose meters should report to FDA’s MedWatch program at or 1-800-FDA-1088 (1-800-332-1088), and to Abbott Diabetes Care.

Abbott’s products are distributed primarily through retail and mail order physicians’ offices and pharmacies.

Class-Action Lawsuit Seeks $600 Million in Connection with Outbreak of Legionnaires' Disease in Toronto Nursing Home that Has Already Killed 21

In the aftermath of one of the deadliest outbreaks of legionnaires’ disease ever, a 58-year-old Toronto resident, who contracted the illness, has commenced a $600 million class-action lawsuit according to a report by CTV News.

That report states in part: “Gerald Glover, 58, was infected with legionnaires’ disease earlier this month during the outbreak at the Seven Oaks Home for the Aged in Scarborough. His family is baffled because Glover lives in a building across the parking lot from the home, and they say he hasn’t even been in Seven Oaks.

Glover collapsed on Oct. 5 and was admitted to hospital with kidney failure, pneumonia, and temporary loss of memory and hearing. Glover’s daughter Cheryl Glover told CTV News that the suit is aimed at addressing her family’s suffering.

‘It’s never been about the money,’ she said. ‘We’ve been to the hospital and seen what they go through my dad has been hooked up to IVs in his arms and a huge one in his neck because of kidney failure, his stomach is all bruised up from being a pin cushion, and we still have no answers.’

The Glover family’s lawyer, Glyn Hotz, said he has received phone calls from others interested in joining the class action suit. He said residents should have been better protected.”

According to Hotz: “Toronto Public Health should have taken measures to protect people in the home. They should have had preventative antibiotics and maybe even have moved people. They certainly should have shut the ventilation off, and instead they warned nobody."

After autopsy results confirmed at least three of the deaths at the Seven Oaks Home for the Aged in Toronto were directly linked to legionnaires’ the disease, the search intensified to find the source of the outbreak.

Although health officials had been stressing the fact that all of the dead have been elderly and infirm and that there is no danger to the general public, 30 employees, 26 visitors to the home, one hospital worker, and four people who live or work in the area (including Glover) had also been affected. Including residents of the facility, 127 cases of the disease have been diagnosed.

The search for the source of the disease was conducted by the Public Health Agency of Canada. Plumbing and air conditionaing systems at Seven Oakes were checked and a scan of a one-mile radius around the facility was conducted.

Three scientists and two technicians from the agency’s National Microbiology Laboratory were also sent to Toronto to conduct numerous tests aimed at locating the point of origin of the bacterium known as legionella pneumophilus bacterium. Environmental specialists were also called in to help identify possible sources of the bacteria.

Finally, last Friday, it was announced that the source of the outbreak was traced to the cooling tower on the roof of the nursing home. The bacteria samples from the cooling unit were found to be the same as those taken from the infected residents.

The cooling tower had been shut down on October 6, the day that legionnaires’ disease was identified as the probably cause of the outbreak.

Health officials concluded that an air intake for the home’s ventilation system located next to the cooling tower allowed droplets of water containing the bacteria to be spread through the home by the ventilation system. There was no immediate evidence that the cooling tower had been improperly maintained.

Airborne droplets from the tower were blamed for spreading the illness to the four people in the vicinity of the nursing home who were also infected.

Shortly before Friday’s press conference, the 20th death among the home’s residents was announced. That number has since risen to 21 with the death of an 89-year-old resident of the home. Presently, eight victims of the disease remain hospitalized.

Study Shows Improvement Needed to Reduce Chemotherapy Errors

A study conducted by researchers at Dana-Farber Cancer Institute (DFCI) and Brigham and Women’s Hospital (BWH), and published in the online journal Cancer, evaluated chemotherapy errors that occur during outpatient care.

The researchers report that while the mistakes they found were not life-threatening, error prevention could still be more effective.
Both DFCI and BWHl, which are in the forefront of efforts to provide excellent standards of care and increased patient safety, consented to share drug-order and patient-safety records with investigators.

The research teams at the two institutions evaluated, over 10,000 medication orders from Dana-Farber’s adult and pediatric ambulatory oncology infusion clinics.

Researchers determined that 3% of the orders contained errors, one-third of which were considered serious. 82% of the errors in adults and 60% in children were found to be possibly hazardous.

Pharmacists and nurses, however, caught 45% of these dangerous errors before they reached patients, and none turned out to be detrimental.  

The most common error in both the adult-clinic, which is computerized, and the pediatric clinic, which uses a paper system, was omitted or incorrect dosages and failure to discontinue orders.

The results show that, while safeguards such as computerized order-entry systems — used at both Dana-Farber and Brigham and Women’s — significantly reduce drug-order errors, additional improvements are still possible, and essential.

To address the problem with order errors, DFCI is implementing a series of new policies including the transfer of the pediatric clinic to computer orders.

In the adult clinics, the computer system has been upgraded to incorporate more detailed information. For example, physicians must now order drugs that need to be administered together simultaneously.

Avian Flu Rapid Response Team Formed by the FDA

In response to the possible threat of an avian flu pandemic, the Food and Drug Administration (FDA) has announced the formation of a Rapid Response Team to ensure that an adequate supply of anti-influenza drugs, such as Tamiflu, are available for Americans.

In partnership with the Department of Health and Human Services, Centers for Disease Control and Prevention, National Institutes of Health and Industry, the Rapid Response Team will work to ensure that every necessary measure is taken to provide an adequate and timely supply of avian flu treatments.

They will address roadblocks to increased manufacturing of products that have already been proven effective against avian flu, they will support clinical studies to test new potential treatments for avian influenza, and they will facilitate the development and availability of safe and effective pandemic vaccines.

The FDA is also taking steps to counter the sale of counterfeit or fraudulent avian flu treatments.  They are working with individuals in the U.S. drug distribution system to strengthen the safety and security of the domestic drug supply by:

·    Actively monitoring internet sites and partnering with internet service providers to identify and stop fraudulent activity.
·    Aggressively seeking out and prosecuting those who seek to prey on innocent people in a time of crisis.
·    Encouraging pharmaceutical manufacturers to take advantage of new technologies that provide protective packaging and other features to ensure that products are both authentic and tamperproof.

The FDA Counterfeit Alert Network is ready to help disseminate information in the event of a counterfeit incident.  To minimize the risk of counterfeit or fraudulent flu treatments, the FDA recommends the following:

·    Consumers should buy medicines only from U.S. state-licensed pharmacies.
·    When buying medicines over the Internet, consumers should look for the National Association of Boards of Pharmacy VIPPS seal.  This seal tells consumers that the web site has been certified and it is a legitimate pharmacy.
·    Only use medicine that had been prescribed for you by your doctor and do not rely on websites that will provide you with a prescription for medicines without a true doctor-patient relationship.

Heath Care Cost Discrepancies in the U.S. Tied to Physician Behavior

As new data emerges that health care spending has little relationship to health outcomes, a new study finds a correlation between the behavior of doctors and the total heath care dollars spent.

According to researchers at the VA Outcomes Group in White River Junction, Vermont and Dartmouth Medical School, physicians practicing in regions of the United States where health care spending is high are more likely to order tests, referrals, and treatments for their patients than those in low-spending regions.

Health care spending varies widely across the county and the study sought to determine whether spending discrepancies were due to patients being different (higher illness rates in certain parts of the country) or doctors being different.

The researchers surveyed 5490 primary care physicians, presenting them with clinical scenarios and asking how often they would order a specific test, referral, or treatment for each patient described.  They found that doctors who practiced in areas of high-spending consistently ordered more tests, referrals, and treatments than doctors who practiced in low-spending areas.

For example, when presented with a 35-year old man with prolonged back pain and foot weakness after heavy lifting, physicians in high-spending regions would order an MRI scan 82% of the time.  This compared to 69% of the time for physicians in low-spending regions.

The study’s primary author, Dr. Brenda Sirovich, Staff Physician at the White River Junction VA Medical Center and assistant professor of medicine at Dartmouth Medical School said “The strength of this study is that we were able to isolate the role of physicians in explaining the huge differences that we see in practice and spending across the regions.” 

The authors acknowledge that it is unlikely that physician behavior alone explains higher levels of spending in some regions of the country, and that differences in patient expectations may influence spending as well.  They do suggest that health care in the United States could cost up to 30% less if all regions could safely adopt the more conservative practice patterns of lower-cost regions.

The study appears in the October 24, 2005 issue of Archives of Internal Medicine.

Heart Attack Death Rates Higher in Hospitals that Treat Larger Share of African Americans

A new study finds that there is a direct correlation between the racial composition of a hospital’s patients and their health outcomes.  

Led by researchers at Dartmouth Medical School, the study found that death rates for all patients were significantly higher in hospitals that disproportionately serve African Americans than in hospitals that serve mainly white patients.  The researchers suggest that it is the quality of care, rather than the racial differences, which determines the high death rate.

Led by Jonathan Skinner, Ph.D., of Dartmouth Medical School, the research team analyzed the records of Medicare patients who where treated for heart attacks in U.S. hospitals between January 1997 and September 2001.  More than 1.13 million adults were included in the study.

Skinner and his colleagues classified hospitals that treated Medicare heart attack patients into 10 groups, depending upon the extent to which they served African Americans.  After adjusting for factors such as age, race and sex, the 90-day mortality rate after a heart attack was 20.1% in hospitals serving no African Americans and 23.7% in hospitals with the greatest share of black heart attack patients a 19% higher rate.

The difference in mortality rates was also not explained by factors such as patients’ income, region of the county, or type of hospital ownership.  “We suspected that these differences could have been caused by the higher rates of poverty among the elderly African American population, but this was not the case,” Skinner noted.  He also said the differences could not be attributed to the likelihood of the hospital providing certain post-heart attack surgical interventions, such as coronary artery bypass grafting.  

The study points out that 69% of the African Americans were treated at just 21% of the hospitals.  These hospitals were more likely to be teaching facilities, more likely to be government-run, and less likely to be not-for-profit.

“Our research is consistent with the view that African Americans tend to go to hospitals where everyone gets lower quality care,” Dr. Skinner said.

The study was published in the October 25, 2005 edition of Circulation: Journal of the American Heart Association, and it was funded in part by the National Institute on Aging.

Consumer Products Safety Commission (CPSC) Issues Advisory on Child Strangulation Risk Posed by Older Window Coverings

The CPSC, the Window Covering Safety Council, and independent retailers have joined forces for Window Covering Safety Month to advise consumers on the importance of repairing or replacing window coverings purchased prior to 2001.  

Young children can strangle themselves when they become entangled in the inner or outer cord on older window coverings.  

There have been about 200 reports of strangulation deaths involving cords and chains on window coverings since 1991.  The outer pull cords are typically responsible for these deaths but at least 20 of these deaths were attributed to the inner cords which run through horizontal blinds.

Strangulation deaths from inner-pull cords primarily involve ages 2 months to 20 months while outer cord deaths typically involve children ages 7 months to 6 years.  Some of the youngest victims die as a result of their crib or playpen being within reach of window coverings.  

Redesigned products have been manufactured by the window covering industry in hopes of reducing cord hazards.  Some of the features of the redesigned models are reduced occurrences of hazardous loops and tie-down anchors and built-in chord straps that are permanently attached.

Despite the attempts to repair and redesign window coverings, the risk of strangulation is still prevalent because of long, dangling window cords and chains.  Consumers should avoid tying window blind cords or chains together at all costs because the knot only creates a new hazardous loop.

Throughout the month of October, CSPC is strongly urging consumers to closely inspect the cords and chains of all their window coverings and to think about using cordless coverings and other alternatives wherever possible.  

Any consumers with window coverings purchased prior to 2001 can obtain a free repair kit from the Window Covering Safety Council’s Web site at or by calling (800) 504-4636.  Individuals can also visit to learn more about window covering safety.

These five safety tips are offered by the CPSC:

1.    Move all cribs, beds, furniture, and toys away from windows and window cords, preferably to another wall.
2.    Keep all window cords out of the reach of children.  Make sure that tasseled pull cords are short, and that continuous loop cords are permanently anchored to the floor or wall.
3.    To prevent inner-cord hazards, lock cords into position when lowering horizontal coverings or shades.
4.    Repair window coverings, corded shades, and draperies manufactured before 2001 with retrofit cord-repair devices, or replace them with today’s safer products.
5.    Consider installing cordless window coverings in children’s bedrooms and play areas.

Indiana Nursing Home Investigated in Series of Abuse Incidents

State officials in Indiana (U.S.) have banned the Hanover Nursing Center from admitting any new residents as the result of an investigation into a series of incidents involving the abuse of several elderly inhabitants.  

One such incident involved a 79-year-old woman who was severely beaten and left with a bloody face.

The Indiana Department of Health has released a report indicating that four Hanover residents were physically or verbally abused since August of 2005.  The agency issued an emergency order banning the admission of new residents to the facility. A daily fine of $4,050, which began at the end of August, was also recommended.

Two former Hanover aides are facing charges in relation to the abuse allegations.  One is facing a felony battery charge for an attack on a female Alzheimer’s patient and the other is facing a misdemeanor charge for failing to report the event.  Both aides pleaded not guilty but are now facing trial on January 12, 2006.  

The former aide charged with felony battery is Amy Johnson, who is accused of attacking a female resident in the center’s Alzheimer’s unit on August 30.

According to the state’s report, Johnson, 28, wrapped her left arm around the resident’s neck, punched her in the face, and then asked her "how she liked it." Following the assault, the elderly woman had blackened eyes and blood gushing from her mouth and nose.

Seven other employees were fired because of claims of abuse, including an incident where a male resident was choked "so hard he was turning blue." He also had his thumbs bent back by two aides when he refused to go to bed.

Hanover is managed by Medical Rehabilitation Centers Inc., of Lexington, Kentucky.  Executives of the company have called these abuse claims isolated incidents and said that they are enforcing a zero-tolerance policy on abuse like many other nursing homes. The Hanover nursing home is one of 15 such facilities in Indiana, Illinois, and Wisconsin managed by Medical Rehabilitation Centers.

Medical Rehabilitation Centers claims that the rest of the employees at Hanover are angered and outraged about the alleged abuse.  The company has also established an anonymous abuse hotline.

A state monitor and two consultants are currently working at the nursing home to effect changes designed to prevent such incidents in the future. The Department of Health plans to conduct a follow-up inspection within the next 45 days to determine if remedial measures have been implemented at the center. 

Consumer Products Safety Commission (CPSC) and Dana Innovations Announce Recall of Amplified Volume Controls for Burn or Fire Hazard

The CPSC has announced the voluntarily recall of In-wall amplified volume control keypads manufactured in Taiwan by Dana Innovations, of San Clemente, California. Consumers should stop using the product immediately.

The amplifier in the keypad can overheat, posing a burn or fire hazard. Dana Innovations has received one report of overheating. There are no reports of injury or property damage.

The recalled controls were sold under the brand names Architectural Audio and HomeTech, and were professionally installed as part of whole house audio systems.

The switch plate covers for the recalled systems are white or almond, and “aVc” (amplified volume control) is imprinted above the volume control. They have the following model numbers:

Brand                         Model Numbers
Architectural Audio     20127
Architectural Audio     20128
HomeTech                  10114
HomeTech                  10115

The model number is not visible to the consumer, and consumers are instructed not to remove the keypads from the wall to look for a model number. All serial numbers are included in the recall.

The controls were sold through custom installation dealers and through homebuilders nationwide from May 2003 through June 2005 for about $150.

Consumers should turn off and stop using these amplified volume control keypads immediately, and contact Dana Innovations to arrange for a free replacement. Dana Innovations distributors are directly contacting consumers with the recalled systems.

For further information, call Dana Innovations toll free at (888) 484-6782 between 7 a.m. and 5 p.m. PT Monday through Friday.




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