Dietary Reference Intakes for Calcium and Vitamin D, A New Report

The report “Dietary Reference Intakes for Calcium and Vitamin D” will be released to the public on November 30, 2010 at 10 am Eastern. The report release will be broadcast via live video webcast. 
If you like to watch the webcast, you need to register and that could be done by following this link, 'Register for this Meeting' The webcast will also be made available for viewing online about a week after the release.
At the time of the release, it will be possible to view the report online at www.iom.edu/vitamind or by linking to the website of the National Academies Press (www.nap.edu).  The report will also be available for purchase as hardcopy or as a PDF from the National Academies Press.
The last recommended level for those two nutrients was made in 1997 and since then various studies have found many benefits of Vitamin D and also have linked the deficiency of it to higher risk of cancer, cardiovascular disease, depression, infectious disease and other ailments.
With the push from various quarters like supplement makers, it is possible that the Institute of Medicine will raise the “dietary reference intake’’ for vitamin D. The current recommendations are 200 international units for people 50 and younger; 400 I.U. for those aged 51 to 70; and 600 I.U. for those 71 and above.
Then why is Calcium there? It is because one of the main roles of vitamin D is to help maintain the right levels of calcium in our bodies, therefor both of them are often considered together.
Institute of Medicine via NYT

Xanodyne Pharmaceuticals, Inc. Pulls Darvon® and Darvocet-N® Products

Xanodyne Pharmaceuticals Inc., the manufacturer of Darvon and Darvocet-N, widely used painkillers in the U.S. taking the products off the market because of a new study linking the active ingredient in the drugs to serious and sometimes fatal heart rhythm abnormalities.
The drug maker initiated the ban at the request of the Food and Drug Administration, which also asked makers of generic versions of the drugs' core compound, propoxyphene, to stop selling it in the U.S.
Following is the press release;

NEWPORT, Kentucky -- Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon®, Darvon-N®, and Darvocet-N® products from the U.S. market in consultation with the U.S. Food and Drug Administration (FDA).
This withdrawal is part of a market-wide withdrawal applying to all propoxyphene-containing products, affecting branded and generic pharmaceutical companies and a number of products on the market. 
Propoxyphene is a mild opiate used for the treatment of mild-to-moderate pain and has been on the U.S. market for the last 50 years.
On January 30, 2009, a meeting of the FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened to review the efficacy and safety of propoxyphene-containing products.  Following that meeting, Xanodyne agreed to work together with the FDA, and took a number of steps including developing a patient medication guide, strengthening several of the warnings in the product labeling, and conducting a clinical study to assess the maximum tolerated dose and effects of propoxyphene on cardiac conduction.
As a result of the availability and ongoing analysis of drug safety surveillance data and developing clinical information about the effects of propoxyphene on cardiac conduction, the FDA has determined that the benefits of propoxyphene-containing products no longer outweigh the potential risks.  Patients should consult their physicians for instructions on how to safely transition to appropriate alternatives.  For further information, patients can call Xanodyne’s medical information line in the United States at 1 (877) 773 7793 or visit www.xanodyne.com.
Contact:

Josh Galper
Orrick, Herrington & Sutcliffe LLP
202 339 8468
Jgalper@orrick.com

Cardinal Health to buy NY pharma distributor Kinray for $1.3 Billion

DUBLIN, Ohio, Nov. 18, 2010 /PRNewswire-FirstCall/ -- Cardinal Health (NYSE: CAH) today announced plans to acquire Kinray, Inc., a leading pharmaceutical distributor serving the New York metropolitan area, for $1.3 billion in an all-cash transaction that will significantly expand its ability to serve retail independent pharmacies in the northeastern United States.
Cardinal Health expects the transaction to be neutral to slightly accretive to non-GAAP earnings in fiscal 2011, depending on the timing of the closing. The company estimates accretion in fiscal 2012 of at least $0.12 in non-GAAP earnings per share from continuing operations(1), including the impact of amortization of intangibles. This estimate is dependent on the timing of the closing and final valuation of intangibles.
"Adding Kinray to the Cardinal Health Pharmaceutical Segment portfolio will enable us to build on our increasing presence in community pharmacy and accelerate our growth in this important channel," said George Barrett, chairman and chief executive officer of Cardinal Health. "We are excited to have the Kinray employees join the Cardinal Health family, and we look forward to their contributions. Kinray has a long-standing service tradition with its customers. We intend to continue that tradition, utilizing its customer expertise and Whitestone distribution facility, while creating additional value for its customers through branded pharmaceutical programs, inventory and pharmacy management tools and Cardinal Health's extensive generic drug program."
With annual sales in excess of $3.5 billion, Kinray currently serves more than 2,000 retail independent pharmacy customers as a distributor of both branded and generic pharmaceuticals. The company primarily serves the New York metropolitan area and will establish a stronger platform for Cardinal Health in the northeastern U.S. The addition of Kinray will continue to diversify and broaden Cardinal Health's customer mix by increasing the company's retail independent pharmacy base by 40 percent to approximately 7,000 total customers. Subject to customary closing conditions and regulatory approvals, Cardinal Health plans to complete the transaction by the end of the calendar year or early in 2011.
"Joining forces with Cardinal Health supports Kinray's mission to help retail independent pharmacies serve as an integral provider of care for our evolving health care system," said Stewart Rahr, president and chief executive officer of Kinray. "The combination of Kinray's distribution model with the benefits of the value-added services offered by Cardinal Health will benefit our customers, making them even more efficient and successful in caring for their patients. It also provides our people with the opportunity to join one of the world's premier health care companies – one that understands the value we bring to the retail independent pharmacies we serve."
After the transaction is complete, Kinray customers will be able to tap into a leading line of service offerings from Cardinal Health including its SOURCE(SM) Generics program and additional tools that help improve the back office efficiency of retail pharmacies, including inventory management tools, reimbursement services, managed care contracting services, Specialized Care Centers and local store marketing programs.
Cardinal Health

Medicare Open Enrollment Open Now.

Medicare Open Enrollment opens up in every fall, this fall is no difference. Follow the link to see a video and resource links for help with Medicare Open Enrollment, which will be open from November 15 to December 31.

Oncowikia Blog: Medicare Open Enrollment Open From November 15 To December 31 2010

National Diabetes Month, November! Do Something To Stop, Prevent Diabetes.

November is the American Diabetes Month, even though everyone should be aware of the decease that affects many a people all over the world. It is preventable, or could be delayed with right amount of work. The Diabetes.org is carrying out a campaign to make people aware of diabetes and ways and means to prevent it.
In series of articles and bloggings and may other activities, we too can let as many people know about this decease.
Here is an interview by Dayle with celebrity Bret Michaels,who also suffer from type 1 diabetes;

You’ve had a very busy and extremely successful year so far – what inspired you to add representing American Diabetes Month as the Face of Diabetes to everything else?
This cause is so important to me. Being diagnosed with type 1 diabetes at such a young age had a profound impact on me – it’s a huge part of who I am, so of course this is something I feel incredibly passionate about.

Diabetes doesn’t have to derail your dreams.  I’m so proud to be the “Face of Diabetes;” if my work can remind other people who are struggling with the disease that it is possible to manage diabetes and still live an amazing life, then I’m happy.
What’s your daily diabetes routine look like?
Every day is a battle. You have to wake up and say to yourself, ‘I accept that I have diabetes, and I’m not going to let it run my entire life.’ It’s a fine line, a catch-22, a balancing act. I work to enjoy my life like a regular human being and at the same time keep my blood sugar levels as decent as possible.

Do you find it harder to maintain when you’re on tour?

For sure, being on the road for months on end can mess with my routine. I test my blood sugar about six to eight times a day and eat smaller meals all day long to keep my blood sugar even.
Did you ever struggle with how diabetes fits into your identity?  If so, how did you overcome this?

This is disease is something I’ve been struggling with for more than four decades.  Diabetes is undeniably a huge part of who I am and it is definitely something I’ve worked hard to come to grips with. At the same time, I’ve never let it limit me or hold me back. All I can do is take it one day at a time and be thankful for every day I handle successfully.
You were diagnosed at a young age – what do you remember?
I was six years old when I was diagnosed with diabetes; I remember I was in between kindergarten and first grade. It came on really quickly and I will never forget how extremely sick and dehydrated I was. Everything I drank or ate immediately came out of me. At  two or three in the morning my mom and dad took me to the Harrisburg hospital (in Harrisburg, PA) – the doctors in the emergency room knew what the problem was right off the bat; they recognized that it was type 1 diabetes immediately.
What do you wish someone had told you when you were first diagnosed? What would you say to kids who have just been diagnosed?
When I was first diagnosed I had no idea what was happening to me or going on inside my body. Before my parents took me to the hospital, my stomach was bloated and I was literally drinking almost a gallon of water at a time. Because my parents didn’t know what diabetes was, they were giving me soda to drink, which was not only dehydrating me more, but making my blood sugar go up twice as much. Learning more about the disease and how to keep your blood sugar stable is hugely important in living with the disease, so I would tell kids who have been diagnosed to definitely accumulate as much knowledge as possible about diabetes, just be aware and arm yourself with as much information as you can.
We just celebrated Halloween a few weeks ago, which can be tricky for kids with diabetes.  What was that like for you as a kid?  And, because we’re curious – what did you dress up as? (I’m secretly hoping David Cassidy is an answer here…)
I love Halloween now with my daughters, and I loved it as a kid, too. Even without all the candy. Just dressing up and having a good time going out with all of my friends – for me that was what the holiday was all about.  And you know, I never dressed up as David Cassidy as a kid but maybe I should borrow your idea for next year, it might make a good costume…
Thanks so much for taking the time to share a little about you with us. We hope you have a very happy American Diabetes Month! Do you have any special activities planned for November to celebrate/acknowledge this?
This being American Diabetes Month, I’m trying to speak out about the disease as much as possible.  I really want to be a positive role model for others in the diabetes community who are suffering, so I’m going to stick to my daily routine, keep my blood sugar stable, serve as a positive role model, and take every opportunity to spread awareness about the disease.
Sounds like a great plan! If you could tell the world one thing about diabetes, what would it be?
Diabetes is a disease, yes, but it’s manageable one. You can have diabetes and still accomplish all kinds of unbelievable things. If I can help remind people of that, then I’m incredibly honored. If anything, diabetes is just a challenge to overcome – a prompt to be mindful of and grateful for my health, and a cue to dream bigger and do more.
Diabetes.org

Terbinafine and Amitriptyline - Dry mouth, dizziness, and cardiac toxicity caused by prolonged increase in amitriptyline and nortriptyline (Pamelor) levels

Terbinafine and Amitriptyline

Affecting Drug 

D01BA02  Terbinafine

Effect

Augments

Affected Drug

N06AA09  Amitriptyline

Details

Dry mouth, dizziness, and cardiac toxicity caused by prolonged increase in amitriptyline and nortriptyline (Pamelor) levels

Evidence

Good

Cytochrome P450 enzymes are essential for the metabolism of many medications. Although this class has more than 50 enzymes, six of them metabolize 90 percent of drugs, with the two most significant enzymes being CYP3A4 and CYP2D6. Genetic variability (polymorphism) in these enzymes may influence a patient's response to commonly prescribed drug classes, including beta blockers and antidepressants. Cytochrome P450 enzymes can be inhibited or induced by drugs, resulting in clinically significant drug-drug interactions that can cause unanticipated adverse reactions or therapeutic failures. Interactions with warfarin, antidepressants, antiepileptic drugs, and statins often involve the cytochrome P450 enzymes. Knowledge of the most important drugs metabolized by cytochrome P450 enzymes, as well as the most potent inhibiting and inducing drugs, can help minimize the possibility of adverse drug reactions and interactions. Although genotype tests can determine if a patient has a specific enzyme polymorphism, it has not been determined if routine use of these tests will improve outcomes. 

Reference

http://www.aafp.org/afp/2007/0801/p391.html

oncowikia : Researchers Find A signaling pathway that, when blocked, significantly decreases the spread of pediatric bone cancer.

oncowikia Blog: Pathway That Drives Spread of Pediatric Bone Cance...: "Researchers have identified an important signaling pathway that, when blocked, significantly decreases the spread of pediatric bone cancer...."

FDA Approves Avanir's NUDEXTA, For Treating PSEUDOBULBAR AFFECT

*NUEDEXTA IS FIRST AND ONLY FDA-APPROVED TREATMENT FOR PSEUDOBULBAR AFFECT*

*AVANIR TO HOST CONFERENCE CALL ON NOVEMBER 1, 2010 AT 8:15 AM EASTERN TIME*

ALISO VIEJO, Calif., Oct. 29 /PRNewswire-FirstCall/ -- AVANIR Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA™ (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated neurological conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient's underlying emotional state.
"The FDA approval of NUEDEXTA marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition," said Keith Katkin, president and chief executive officer of Avanir. "The approval of NUEDEXTA also marks AVANIR's transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA. We expect that NUEDEXTA will be available by prescription during the first quarter of 2011."
"This FDA approval represents a significant step forward for people who live with the debilitating effects of PBA," said Dr. Nicholas LaRocca, Vice President of Healthcare Delivery and Policy Research at the National MS Society. "For people who experience unexplained bouts of inappropriate laughing or crying, this new therapy has the potential to substantially help both them and their families."
"Today's approval of NUEDEXTA is a testament to the conviction of the patients and researchers who participated in our studies and represents over 10 years of research and development by our dedicated employees," said Randall Kaye, MD, Chief Medical Officer, AVANIR Pharmaceuticals. "We are very pleased to bring the first proven treatment option to the many patients in the U.S. living with PBA. I would like to thank FDA for working closely with us to make NUEDEXTA available."
"PBA is a disabling neurologic condition commonly found in patients with underlying neurologic diseases or injuries. These patients frequently experience embarrassment due to their unpredictable emotional outbursts, leading to disruption of their interpersonal relationships and social isolation," said Erik P. Pioro, MD, PhD, FRCPC, Director of the Section for ALS and Related Disorders at the Cleveland Clinic in Cleveland, Ohio and an investigator in clinical studies evaluating NUEDEXTA. "As a physician who has cared for many patients with PBA, I am pleased that there is now a safe and effective treatment option for PBA that may help these patients regain more control over their daily lives and live with dignity."
NUEDEXTA is a first-in-class medication that acts on sigma-1 and NMDA receptors in the brain, although the exact mechanism by which NUEDEXTA exerts therapeutic effects in patients with PBA is unknown. Studies to support the effectiveness of NUEDEXTA were performed in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA has not been shown to be safe and effective in other types of emotional lability that can commonly occur, for example, in Alzheimer's disease and other dementias.
The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.
Conference Call
AVANIR will hold a conference call and audio webcast on November 1, 2010 at 8:15 a.m. Eastern time. To participate in the conference call, please dial 877-558-3407 (domestic) or 706-679-1941 (international) and reference the access code 22130601. A live audio webcast of the conference call will be available by visiting AVANIR's website at www.avanir.com. To listen to the live presentation, please go to AVANIR's website prior to the start of the presentation to register, download and install the necessary software. An archive of the conference call will be available on the Company's website for 30 days.

Hi-Tech Life Styles Like Games, Texting Are Affecting Childrens Sleep, Health, Study Finds.

With the new hi-tech toys available in every home and every bedroom, children are playing games, watch TV, Texting and emailing long after bedtime according to a new study. These children develop dyslexic learning problems the following morning due to lack of sleep..
The study covered 40 students sent, on average, 33.5 texts or emails per school night after bedtime -- from 10 minutes to four hours after ''lights out,"  says researcher  Peter G. Polos, MD, attending  physician at the JFK Medical Center sleep laboratory in Edison, N.J.
He is due to present his findings this week at CHEST 2010, the annual meeting of the American College of Chest Physicians in Vancouver, British Columbia.
''It reaffirms my suspicion that the availability of these media to children can or will have a significant impact on their quality and quantity of sleep, Most of the 40 students reported either learning, behavioral, or cognitive issues. This [emailing and texting] is more stimulatory than television, I think," Polos told WebMD.

Dr. Polos and his colleagues surveyed the students, ages 8 to 22, with an average age of 14.5, who had come to the sleep clinic on their sleep habits. More than 77% of the students had persistent problems getting to sleep, he says. The team found boys are more likely to surf the Internet and play games online after bedtime, while girls are more likely to use their cell phone or send text messages.
The 33.5 emails and texts were sent to about four people during a school night.
The average number of awakenings per night due to media was one.
The average number  of  texts sent per month including weekend nights after bedtime was 3,404 per person.
The older the student, the more time he or she was likely to spend texting and emailing after bedtime.
Polos found. “That number reflects a portion of children who were excessively using the media.”
 
The pilot study, Polos says, suggests that bedtime media use "may have an adverse impact on sleep hygiene and daytime function which may be significant." The study didn't prove cause and effect between late-night texting and emailing and impairments in daytime functioning, Polos says. But, he says, a student with a learning disability, for instance, who is also sleepy probably won't be performing at school at his best.
So make kids bedrooms a electronic free zone and make the healthy.

Make the bedroom a technology-free zone, with no TVs, cellphones, iPods, computers or video games

Turn off electronic devices at least half an hour before bed