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FDA tightens Opiod Labeling to stress the dangers of its long term use!

opioidsThe FDA has ordered a class-wide label change for long-acting opioids such as OxyContin (oxycodone) aimed at limiting use of these drugs to patients with severe, refractory pain.

The move, announced at press briefing Tuesday, is part of a handful of changes that the agency hopes will curb an ongoing prescription painkiller epidemic, including a label clarification about the risks of abuse and death with the drugs, a requirement for additional postmarketing studies, and a boxed warning about the risks of neonatal opioid withdrawal syndrome.

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Michigan Brain is Pleased to Offer Artificial Disc Replacement

LDR-Mobi-CAUSTIN, TX (August 28,  2013) – LDR, a privately held medical device company offering exclusive spinal implant technologies for both non-fusion and fusion applications, today announced that it has received a letter of approval from the U.S. Food and Drug Administration (FDA) allowing the commercial sale and distribution of the Mobi-C Cervical Disc (Mobi-C) for two-level indications, making it the first and only cervical disc in the United States approved to treat more than one level of the cervical spine.  LDR previously received a letter of approval on August 7, 2013 from the FDA allowing the commercial sale and distribution of the Mobi-C for one-level use.

“We are very pleased that the FDA, after an intensive review of our submissions, has determined that Mobi-C is safe and effective for both one and two-level indications in the United States, and superior to fusion for two-level cervical disc replacement, based on the results of our prospective, concurrently controlled and randomized, multi-center clinical trials,” said Christophe Lavigne, president and CEO of LDR.   “We are proud that LDR is first to offer an on-label, arthroplasty solution for the significant number of patients suffering from two-level cervical disc disease.  It is very gratifying to know that spine surgeons can now offer this new, evidence-based treatment option to their two-level surgical candidates.”

Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications.  In addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique as compared to other, commercially available devices, all of which are approved for one-level use only.

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Migraine May Change Structure of Brain

headache-disordersMigraine was linked to structural brain changes, particularly in the presence of aura, a meta-analysis showed.

White matter brain lesions appeared 68% more often in migraineurs with aura than in those without migraine; a trend for 34% elevated risk of white matter in migraine patients without aura didn’t reach significance, Messoud Ashina, MD, PhD, of the Danish Headache Center at Glostrup Hospital in Copenhagen, and colleagues found.

Clinically-silent infarct-like abnormalities and brain volume changes also correlated with migraine, they reported online in Neurology.

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Where are we with medical marijuana?

medical-marijuanaLegalization of Medical Marijuana

Medical marijuana is legal in 20 states and the District of Columbia, with pending legislation to legalize the drug for medical purposes in 4 others.[1] Although still illegal in 30 states, millions of patients are undoubtably using marijuana for medicinal purposes in these jurisdictions.

Much has been written about politics trumping science with respect to rescheduling marijuana from a Schedule I drug,[2-5] as its medical benefits become progressively more accepted by the mainstream medical community as well as the general public.[6] The Veterans Administration, which is becoming a leader in pain care in the United States, has even approved of its physicians authorizing medical marijuana in states in which it is legal.

Earlier this year, Kondrad and Reid[8]published a large-scale survey-based study of family physicians’ attitudes toward medical marijuana in Colorado — a state in which medical marijuana has been legal since 2000. The results of their investigation were both startling and disturbing. They found that only 19% of respondents believed that physicians should recommend medical marijuana to their patients. However, they also found that 80% of respondents believed that education about medical marijuana should be incorporated into medical school curricula, 82% believed that such education should be included in family practice residency training, and 92% agreed that continuing medical education on medical marijuana should be made available to them. Opposition to recommending medical marijuana as a result of concerns about legal liability or licensure was reported by 23% of respondents, whereas only 13% cited a lack of medical evidence as their reason for opposition. These figures indicate that science is clearly not the primary issue of concern.

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New Hope to Improve Resection of Malignant Brain Tumors: Raman Technology

brain-tumorsAn optical technology for discriminating brain tumors from normal brain may eventually help surgeons in the operating room. Also this week: keeping neuronal growth on the straight and narrow.

New Light on Brain Tumors

When patients with brain tumors undergo surgery, it’s hard for surgeons to tell where tumor ends and normal brain starts, which often means cancerous tissue is left behind. But generous margins may compromise brain function.

Now, a technique known as stimulated Raman scattering microscopy has shown better discrimination in preclinical studies, said investigators led by Sunney Xie, PhD, of Harvard University, who hope to develop the technology into a handheld probe to be used in the operating room.

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Treat atrial fibrillation AF to prevent stroke

pradaxaPRADAXA 150 mg twice daily provided an additional 35% risk reduction of stroke/systemic embolism vs warfarin

  • Superior reduction of ischemic and hemorrhagic stroke vs warfarin
  • Similar rate of major bleeds‡ with PRADAXA vs warfarin
  • PRADAXA is the ONLY anticoagulant to demonstrate superior reduction of ischemic stroke vs warfarin
  • PRADAXA also demonstrated a lower rate of intracranial bleeding vs warfarin

Additional 35% risk reduction of stroke/systemic embolism vs warfarin. Protect the brain by reducing the risk of ischemic stroke.

Learn more at pradaxapro.com

How we can protect from cell phones?

phoneRealistically, most people reading this article will not be decommissioning their iPhones or androids anytime soon. These devices enable us to stay closely connected to our loved ones, as well as to connect to the global brain which is the internet. But what this research does implore us to do is to exercise caution. Here are a few steps to take to reduce exposure:

  • Wear a headset or earphones to keep the device as far away from your head and/or other vital organs as possible.
  • Turn the device off whenever it is not being used.

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Useful Headache Guidelines

headache-disordersDiagnosis and treatment of headache

Major Recommendations and Clinical Highlights

  • Headache is diagnosed by history and physical examination with limited need for imaging or laboratory tests.

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Delaying Retirement May Reduce Risk for Dementia

dementiaAn older age at retirement may be associated with a significantly decreased risk of dementia, according to research presented at the 2013 Alzheimer’s Association International Conference. In a study of 429,803 retired French workers, Carole Dufouil, PhD, and colleagues found that the hazard ratio of dementia was 0.968 for each extra year of age at retirement.

“Our results highlight the importance of maintaining high levels of cognitive and social stimulation throughout work and retiree life and emphasize the need for interventions and policies to help older individuals achieve such cognitive and social engagement,” stated Dr. Dufouil, Director of Research in Neuroepidemiology at INSERM in Paris.

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Sleep Helps Our Memory

sleeping-womanEvery night, while we lie asleep, blind, dumb and almost paralyzed, our brains are hard at work. Neurons in the sleeping brain fire nearly as often as they do in a waking state, and they consume almost as much energy. What is the point of this unceasing activity at a time when we are supposedly resting? Why does the conscious mind disconnect so completely from the external environment while the brain keeps nattering on?

The brain’s activity during rest likely serves some essential function. The evidence for this importance starts with sleep’s ubiquity. All animals apparently sleep even though being unconscious and unresponsive greatly raises the risk of becoming another creature’s lunch. Birds do it, bees do it, iguanas and cockroaches do it, even fruit flies do it, as we and others demonstrated more than a decade ago.

Sleep must serve some vital function because all animals do it. Evidence suggests that sleep weakens the connections among nerve cells, which is a surprising effect, considering that strengthening of those connections during wakefulness supports learning and memory. But by weakening synapses, sleep may keep brain cells from becoming oversaturated with daily experience and from consuming too much energy.

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