LifeScan recalls OneTouch VerioIQ blood-glucose meters
MILPITAS, Calif. — LifeScan on Monday initiated a voluntary recall and replacement for all of its OneTouch VerioIQ blood-glucose meters in the United States, effective immediately.
“Our patients’ safety is our number one priority,” stated Michael Pfeifer, LifeScan’s chief medical officer. “When we learn that a product does not fully meet our expected standards, we will voluntarily notify our customers and patients and take corrective action. We regret the inconvenience these actions may cause. However, we will always err on the side of caution and make a decision that is in the best interest of our patients.”
LifeScan is recalling and replacing the meters because at extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning that the blood glucose is extremely high and will shut off, thereby potentially leading to incorrect treatment and delaying proper treatment.
The likelihood of experiencing an extremely high blood glucose level of 1024 mg/dL or higher is remote; however, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention. Because these products do not provide an appropriate warning at glucose levels of 1024 mg/dL or higher, diagnosis and treatment of extreme hyperglycemia may be delayed.
Patients who are using the OneTouch VerioIQ Meter should contact LifeScan Customer Service at (800) 717-0276 to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative. Representatives are available 8 a.m. to 10 p.m. EDT Monday through Sunday. Additional information about this recall is available on www.onetouch.com.
Patients may continue to test with their OneTouch VerioIQ Meters while they wait for their replacement meter to arrive as long as they are aware of this issue, Lifescan stated. However, LifeScan advises that if the meter unexpectedly turns itself off during testing, this could be a sign of extreme hyperglycemia requiring immediate medical attention and the patient should call a healthcare professional.
Notifications are being sent to all registered users, healthcare professionals, pharmacies and distributors wherever these products are sold. LifeScan estimates that there are approximately 90,000 active OneTouch VerioIQ Meter users in the U.S. The company is in the process of implementing an update to the meter to address the issue, however, the timing to resume shipments of OneTouch VerioIQ Meters has not yet been determined.
To date, no adverse events or patient injuries related to this specific issue have been reported for the OneTouch VerioIQ Meter. All other OneTouch blood glucose brands sold in the U.S., including OneTouch Ultra Meters, OneTouch Select Meters and OneTouch Verio Test Strips, are not affected by this recall.
Like this story? Find us on Facebook for more insight, analysis and the latest in drug store news. Join the conversation.
CDC: Of the 105 flu-related pediatric deaths this season, 9-in-10 did not get a flu shot
ATLANTA — An early look at this season’s reports indicates that about 90% of flu-related pediatric deaths occurred in children who had not received a flu vaccination this season, the Centers for Disease Control and Prevention reported Friday.
The number of influenza-associated pediatric deaths reported to the CDC during the current season surpassed 100 as an additional 6 deaths were reported in FluView last week. To date, this brings the total number of influenza-associated pediatric deaths reported to the CDC to 105 for the 2012-2013 season.
The review also indicated that 60% of deaths occurred in children who were at high risk of developing serious flu-related complications. The proportions of pediatric deaths occurring in children who were unvaccinated and those who had high-risk conditions are consistent with what has been seen in previous seasons.
According to CDC survey data, only about 40% of children had received a 2012-2013 influenza vaccine by mid-November of 2012. The final estimated vaccination rate among children during the 2011-2012 season was 52%.
Across all age groups, this season’s vaccine was found to be about 60% effective in preventing medically attended influenza illness. This number was lower among people 65 and older, but flu vaccination reduced a child’s risk of having to go to the doctor because of flu by more than 60%.
CDC recommends annual flu vaccination as the first and best step in preventing influenza. CDC recommends antiviral drugs as a second line of defense against flu for those people who are seriously ill and those who are at high risk of flu complications, even if they have been vaccinated.
Boiron owner publishes homeopathy desktop reference
NEWTOWN SQUARE, Pa. — Boiron owner Michèle Boiron recently published a book on homeopathy for healthcare professionals titled "Homeopathy and Pharmaceutical Care," the company announced. In April 2013, she and co-author François Roux will host lectures in Philadelphia and New York.
"As patient and healthcare professional interest in homeopathic medicines grow, this concise desk reference fills the gap between advanced technical references for prescribers and book on self-treatable conditions for lay people," the homeopathic company stated.
A brief introduction covers homeopathic pharmacology basics and provides guidelines for dosage, storage and general use of these medicines. Afterward, the therapeutic section lists the protocols that can be used for more than 56 conditions where homeopathic medicines can be simply and reliably recommended. Each section begins with a short physio-pathological synopsis. Symptoms are listed next along with corresponding medicines and dosages for an easy assessment of the treatment. The authors clearly indicate the conditions that require physician intervention, thus remaining in the safe scope of consulting.
Purchasers of this book will be given the option to and instructions on creating a free online account to access updates. Protocols in the book will be hyperlinked to a summarized version of The Materia Medica and drug facts for branded medicines. Prescribers can therefore easily toggle between the information. Additionally, prescribers can create a customized recommendation template with their business information and print it as a convenient take-away for patients.