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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.

http://www.fda.gov/medwatch/safety/2005/safety05.htm#Zevalin

The alert and warning revision (http://www.fda.gov/medwatch/safety/2005/ZevalinPI.pdf) 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.

http://www.fda.gov/medwatch/safety/2005/Zevalin_dearhcp.pdf

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). 

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 http://www.fda.gov/medwatch/ 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.

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.