US Food and Drug Administration Issues Warning About Lymphoma Drug Brentximab

The US Food and Drug Administration (FDA) has issued a warning about the lymphoma drug brentuximab (Adcetris, Seattle Genetics).

This warning comes after two new cases of progressive multifocal leukoencephalopathy a rare but serious brain infection.

A new Boxed Warning highlighting this risk has been added to the drug label.

In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of lung toxicity.

Brentuximab was approved by the FDA in August 2011 for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma.

Healthcare professionals should suspend brentuximab dosing if PML is suspected, and discontinue the drug therapy if a diagnosis of PML is confirmed, according to the FDA.

Source: FDA site

IHEalth Announces iHealth Smart Glucometer

iHealth Labs has announced the iHealth Smart GlucoMeter, a blood glucose system that can be connected to with dongle to iPad, iPhone, iPod Touch with an attached dongle.
Almost similar to Sanofi/AgaMatrix’s iBGStar, it consists of a test strip reader that gets attached the devices mentioned above and the process of glucose testing can be carried with standard strips.
There is also an application along with which can store the data and create charts up of previous 30 days.
iGLucometer from ihealth labs
All the announced products will also use iHealth’s iHealth Cloud Service to instantly and securely back-up and store their results in the cloud.

Image Credit: Engadget

Immune Modulation By Stem Cells May Lead To Reversal of Diabetes Type I

Immune regulation by healthy cord blood stem cells can enabling the pancreas to produce insulin by educating T cells, the study by Yong Zhao from University of Illinois at Chicago reported.

The study has been published online January 10, 2012, in BMC Medicine

The authors mention that inability to control autoimmunity is the primary barrier to developing a cure for type 1 diabetes.

For the study Yong Zhao and colleagues develop a stem cell educator therapy in which a patient’s blood is circulated through a closed-loop syserapyhtem that separate lymphocytes from the whole blood and briefly co-cultures them with adherent cord blood stem cells before returning them to the patient’s circulation.

In an open-label trial, 15 patients between age 15-41 years and median history of diabetes received one treatment with the Stem Cell Educator.

The therapy was well tolerated in all participants and persons who received therapy displayed betterment.

In six patients with some residual beta cell functions the therapy markedly improved C-peptide levels, reduced the median glycated hemoglobin A1C (HbA1C) values, and decreased the median daily dose of insulin
In six patients with no residual pancreatic islet beta cell function, the treatment also produced an increase in basal and glucose-stimulated C-peptide levels through 40 weeks.

However, participants in the Control Group (n = 3) did not exhibit significant change at any follow-up.

All individuals who received Stem Cell Educator therapy exhibited increased expression of costimulating molecules like CD28 and ICOS, increases in the number of CD4+CD25+Foxp3+ regulatory T cells, and restoration of Th1/Th2/Th3 cytokine balance.

Authors concluded that stem cell educator therapy is safe, and in individuals with moderate or severe T1D, a single treatment produces lasting improvement in metabolic control. The authos also hinted that immune modulation by cord blood stem cells and the resulting clinical improvement in patient status may have important implications for other autoimmune and inflammation-related diseases.

Source: BMC Medicine 2012, 10:3 doi:10.1186/1741-7015-10-3, Abstract

Language Skills In Deaf Children – Bilateral Cochlear Implants Show An Improvement Than Single

Deaf children with profound deafness have shown better spoken language skills than those with a single implant. This has been reported in a study published this month in Archives of Pediatrics & Adolescent Medicine.

The study was carried out by Tinne Boons, at the Katholieke Universiteit Leuven, Belgium, and colleagues. They measured comprehension and expression of spoken language in 25 children with one cochlear implant and in 25 closely matched children with two implants, selected from among 288 patients from two Belgian and three Dutch cochlear implantation centers.

All the children received their implants (manufactured either by Cochlear Ltd or Advanced Bionics LLC) before age two, none had multiple other disabilities, and all had monolingual parents with normal hearing. They were also matched on sex and cause of deafness.

On the Reynell Developmental Language Scales the mean score was 85.6 in the bilateral group versus 76.2 in the unilateral group.

Similarly, for expressive language, the corresponding mean scores for word development on a standardized test were 86.1 versus 70.4, respectively, and 86.8 versus 77.0 for sentence development.

The interval between bilateral implants influenced language performance. Children who received both implants at the same time had better word development scores than those who had sequential dual implants.

SOURCE: Arch Pediatr Adolesc Med 2012;166:28-34.

Helicobacter Pylori May Be Protective Against Some Diarrhoeal Diseases

H pylori infections in stomach  an increased risk of stomach cancer and related diseases but a recent study has suggested that Helicobacter pylori may be protective against diarrhoeal diseases.

The study by Dr. Dani Cohen and colleagues from Tel Aviv University in Israel carried a study in 595 male Israeli soldiers aged 18–21 years, serving in field units and followed up for diarrheal diseases.

177 were grouped as case patients. They were those who visited the base clinic because diarrhea and were positive for either Shigella sonnei (66), enterotoxigenic Escherichia coli  (n = 31) . 80were  negative for bacterial pathogens and were classified into diarrhea of unknown etiology. [Read more...]

Red Meat Intake Has Been Linked To Kidney Cancer

A large US based study has reported that people who eat a lot of red meat are at higher risk of kidney cancer red meat may have a higher risk of some types of kidney cancer namely renal cell carcinoma.

The study has been reported in January edition of the American Journal of Clinical Nutrition.

The study has been done by Carrie Daniel from the National Cancer Institute in Rockville, Maryland, and her colleagues.

Hither to , the evidence of the meat intake and renal cell carcinoma  risk was inconsistent, report the authors. Therefore they we prospectively investigated intake of meat and meat-related compounds in relation to risk of renal cell carcinoma, as well as clear cell and papillary RCC histologic subtypes.

A total of 492,186 participants were surveyed for their dietary habits and were followed fro nine years. 1814 cases of renal cell carcinoma were diagnosed during this period.

Participants with the highest consumption of red meat [ four ounces per day] were 19 percent more likely to be diagnosed with kidney cancer than those who ate the smallest amount[ <one ounce per day]. [Read more...]

Natalizumab

Natalizumab is a humanized monoclonal antibody against the cellular adhesion molecule α4-integrin used in the treatment of multiple sclerosis and Crohn’s disease.

Natalizumab is administered by intravenous infusion every 28 days. The drug is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood-brain barrier.

Natalizumab has been found to be effective in treating the symptoms in both Crohn’s disease and multiple sclerosis. In multiple sclerosis, it also is effective in preventing relapse, vision loss, cognitive decline and significantly improving quality of life in people. [Read more...]

FDA Approves Bupivacaine Extended-Release Liposome Injection (Exparel) for Postoperative Pain

New long-acting nonopioid anesthetic/analgesic for postsurgical pain by US Food and Drug Administration. The drug is bupivacaine extended-release liposome injection (Exparel, Pacira Pharmaceuticals).

Exparel consists of bupivacaine encapsulated in the multivesicular liposome DepoFoam [Pacira Pharmaceutical's extended drug-delivery technology].

The new product is designed to extend the duration of analgesia provided by bupivacaine. Exparel provides continuous and extended postsurgical analgesia for up to 72 hours compared with bupivacaine’s analgesic time of 7 hours.

The new drug is expected to reduce the dependence on opioid use in the postoperative setting.

VoyantLink – Cloud Based Software For Image Sharing And Clinical Planning Announced By Brainlab

Brainlab has announced the VoyantLink, a cloud-based image sharing platform for clinicians, hospitals, and imaging centers.

The above software platform can also be used for patient exaination, planning and templating and other clinical applications.

The software enables users to send, receive, share, and save images. Furthermore, it also offers live collaboration and data enrichment. In planning applications digital templating, mobile applications, workflow automation, dose review, dose planning, and image fusion can be achieved. [Read more...]

H1N1/MRSA Coinfection Increases The Death Risk in Children

An n 8-fold increased mortality rate among children with coinfection by methicillin-resistant Staphylococcus aureus and H1N1 has been observed in a study published online October 17 in Pediatrics.

The possible explanation is the viral assault compromising immunity and the bacterial infection destroying lung tissue.

A significant number of previously healthy children developed severe pneumonia and respiratory failure when infected with H1N1 influenza during the 2009 pandemic.

It is of concern because community-acquired MRSA in children is becoming more prevalent and H1N1 is still in circulation. [Read more...]