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 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.

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 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

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.

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.

Controls (n = 418) were subjects who did not suffer from a diarrheal disease during the follow-up. They were matched to case patients by training unit and period.

Serum samples were obtained from participants at the beginning of their field training and were tested for anti–H. pylori immunoglobulin (Ig) G and preexisting Shigella sonnei lipopolysaccharide IgG and IgA antibodies using enzyme-linked immunosorbent assay.

Results. The proportion of H. pylori infected subjects was significantly lower among case patients with infection of unknown etiology (36.3%) than among controls (56.0%).

Same finding was noted for  H. pylori–infected subjects among case patients with S. sonnei shigellosis

The authors have concluded that H. pylori has active protective role against diarrheal diseases.

Source: Clin Infect Dis. (2011) doi: 10.1093/cid/cir916

First published online: December 9, 2011 .

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].

The association between red meat and cancer was stronger for papillary carcinoma than clear-cell carcinoma.

People who ate the most well-done grilled and barbecued meat had an extra risk of kidney cancer.

The authors recommended to limit intake of red and processed meats and advised better preparation of meat by cooking methods such as baking and broiling.”

Source: American Journal of Clinical Nutrition, January 2012.

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.

It is effective in increasing rates of remission and preventing relapse in Crohn’s disease.

Mechanism of Action

Natalizumab is a humanized monoclonal antibody against alpha-4 (α4) integrin, which is required for white blood cells to move into organs. Thus natalizumab’s mechanism of action is believed to be the inhibition these immune cells from crossing blood vessel walls to reach affected organs.

Multiple Sclerosis

In multiple sclerosis, symptoms are believed to be caused when inflammatory cells such as T-lymphocytes pass through the blood-brain barrier through interaction with receptors on the endothelial cells.

Natalizumab appears to reduce the transmission of immune cells by interfering with the α4β1-integrin receptor molecules on the surfaces of cells.

The effect appears to occur on endothelial cells expressing the VCAM-1 gene, and in parenchymal cells expressing the osteopontin gene. I

Crohn’s disease

The interaction of the α4β7 integrin and the addressin  endothelial cell receptor is believed to contribute to the chronic bowel inflammation that causes Crohn’s disease. Addressin is primarily expressed in the endothelium of venules in the small intestine and are critical in guiding T-lymphocytes to lymphatic tissues in Peyer’s patches.

Patients with Croh’s disease have increased expression of addressin. Natalizumab is thought to block interaction between the α4β7 integrin and addressin at sites of inflammation.

Adverse Effects

• Fatigue
• Allergic reactions
• Exacerbation of Crohn’s disease in a minority of patients
• Liver injury
• Progressive ultifocal leukoencephalopathy [an opportunistic infection caused by the JC virus]

  Interactions

Drug has only been linked to Progressive ultifocal leukoencephalopathy when combined with other immune-modulating drugs.

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.

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.

Working of Voyantlink - The Cloud Based Clinical Software

The software can be integrated with Brainlab’s existing portfolio of software for control of patient data throughout the treatment cycle.

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.

The study was conducted by Members of the Pediatric Acute Lung Injury and Sepsis Investigator’s Network. A data from 838 children, with median age 6 years, treated at 35 US pediatric intensive care units for probable H1N1 influenza from April 2009 to April 2010.

Most patients were in respiratory failure. About sixty eight percent required mechanical ventilation and 3.9% received extracorporeal membrane oxygenation.

Despite aggressive treatment 8.9% of the children [75] died.

Overall, 71 (8.5%) of the patients had presumed diagnosis of early S aureus infection of the lung, with 48% of those apparently being MRSA.

Of the 838 children, 587 had 1 or more chronic health conditions, including asthma, compromised immune deficiency, or a neurological disorder.

Among the 251 previously healthy children, the only shared risk factor for those who died was MRSA lung infection.

26 of 251 previously healthy children had S aureus lung infection. Eight out of 18 hildren who died also had Staph aureus infection[ Six were confirmed to have had MRSA.

Most of the children receiving vancomycin did not survive.

Because of the speed with which either or both infections develop, the researchers advise immediately treating children presenting with severe lower respiratory tract diseases during influenza season with antivirals such as oseltamivir, as well as antibiotics, without waiting for laboratory confirmation of the infections.

Influenza vaccination is the most effective approach for minimizing morbidity and mortality in coinfected children, authors note.

Limitations of the study

• Confirmation of H1N1 in only 65% of cases
• Lack of systematic detection of additional respiratory pathogens
• Bacterial infections masked by use of broad-spectrum antibiotics
• Restricted sampling [Only large pediatric facilities sampled]

Pediatrics. Published online October 17, 2011. Abstract