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Wyeth Recalls Several Robitussin Products From US Shelves

October 31, 2007

Robitussin DimetappWyeth Consumer Healthcare, a division of Wyeth, today announced it has initiated a voluntary recall and replacement program for all U.S. retail outlets that sell several Robitussin(R) products and Children’s Dimetapp
Cold & Chest Congestion.

The program involves removal of existing products
with a dosage cup that does not have a half-teaspoon mark, which is the
recommended dose for children age two to under six. This action is specific
to the dosage cup and not related to the medication itself. For children
age two to under six, the Company is advising consumers not to use these
medicines until the replacement products with the new cup are available.

The replacement products with the new dosage cup are expected to be
available beginning in early November 2007. Packaging for the replacement
products will be marked to indicate that the new dosage cup is included.

The recall and replacement program for these products does not affect
other Robitussin and Dimetapp cough and cold products.
    Products Being Recalled & Replaced:
     — Robitussin(R) Cough DM
     — Robitussin(R) Cough & Cold CF
     — Robitussin(R) Cough & Congestion
     — Robitussin(R) Chest Congestion
     — Robitussin(R) Head & Chest Congestion PE
     — Robitussin(R) Cough Sugar Free DM
     — Children’s Dimetapp(R) Cold & Chest Congestion
    Important Instructions for Parents and Caregivers
    We recommend that parents and caregivers of children age two to under
six do the following:
    — Do not use these medicines in children age two to under six because
    the dosage cup does not have a half-teaspoon mark, which is the dose
    on the label of these products for this age group.
    — Consult their healthcare professional concerning the most
appropriate
    way to treat cough and cold symptoms for children age two to under
    six.
    — Call 1-800-762-4675 for more information.
    More information on these Robitussin products or Children’s Dimetapp
Cold & Chest Congestion can be found at Dimetapp.com or Robitussin.com or
by calling 800-762-4675.

Source: Wyeth

Study Shows No Connection Between Vitamin D And Reduced Overall Cancer Deaths

October 31, 2007

Vitamin D

No relationship was found between vitamin D levels and the overall risk of dying from cancer, according to a study published online October 30 in the Journal of the National Cancer Institute. However, higher vitamin D levels were associated with a decreased risk of colorectal cancer death.

Several epidemiological studies have supported the hypothesis that that vitamin D can reduce cancer mortality by decreasing cancer incidence or improving survival. Animal and cell studies suggest that vitamin D may reduce tumor growth and induce cancer cell death. Diet and exposure to sunlight are the major sources of vitamin D.

D. Michal Freedman, Ph.D., of the National Cancer Institute in Bethesda, Md., and colleagues analyzed data from the third national Health and Nutrition Examination Survey to examine the relationship between levels of circulating vitamin D in the blood and cancer mortality in a group of 16,818 participants aged 17 and older.

After about a decade of follow-up, 536 participants had died of cancer. Cancer mortality was not related to the level of circulating vitamin D for the overall group, nor was it related when the researchers looked at the data by sex, race, or age. But higher levels of vitamin D (80 nmol/L or more) were associated with a 72 percent reduced risk of colorectal cancer mortality, compared with lower levels (less than 50 nmol/L).

“To our knowledge, this study is the first to examine the relationship between measured serum vitamin D levels and cancer mortality for selected site and for all sites combined,” the authors write.

In an accompanying editorial, Cindy Davis, Ph.D., and Johanna Dwyer, D.Sc. of the National Institutes of Health in Bethesda, Md., discuss the complicated relationship between nutrients, like vitamin D, and cancer. They suggest that not enough is known about the benefits and limitations of vitamin D to use it for the prevention of disease or death.

“These findings must be put into the context of total diet and lifestyle. There are many risk factors other than diet for colorectal cancer, and there are many possible dietary risk factors other than vitamin D that have been linked to cancer risk,” the editorialists write.

Source: Journal of the National Cancer Institute

Study Shows Link Between Sleep Deprivation And Psychiatric Disorders

October 24, 2007

sleep deprivation neurological basis

It has long been assumed that sleep deprivation can play havoc with our emotions.

This is notably apparent in soldiers in combat zones, medical residents and even new parents. Now there’s a neurological basis for this theory, according to new research from the University of California, Berkeley, and Harvard Medical School.

In the first neural investigation into what happens to the emotional brain without sleep, results from a brain imaging study suggest that while a good night’s rest can regulate your mood and help you cope with the next day’s emotional challenges, sleep deprivation does the opposite by excessively boosting the part of the brain most closely connected to depression, anxiety and other psychiatric disorders.

“It’s almost as though, without sleep, the brain had reverted back to more primitive patterns of activity, in that it was unable to put emotional experiences into context and produce controlled, appropriate responses,” said Matthew Walker, director of UC Berkeley’s Sleep and Neuroimaging Laboratory and senior author of the study, which will be published Oct. 22 in the journal Current Biology.

“Emotionally, you’re not on a level playing field,” Walker added.

That’s because the amygdala, the region of the brain that alerts the body to protect itself in times of danger, goes into overdrive on no sleep, according to the study. This consequently shuts down the prefrontal cortex, which commands logical reasoning, and thus prevents the release of chemicals needed to calm down the fight-or-flight reflex.

If, for example, the amygdala reacts strongly to a violent movie, the prefrontal cortex lets the brain know that the scene is make-believe and to settle down. But instead of connecting to the prefrontal cortex, the brain on no sleep connects to the locus coeruleus, the oldest part of the brain which releases noradrenalin to ward off imminent threats to survival, posing a volatile mix, according to the study.

The study’s findings lay the groundwork for further investigation into the relationship between sleep and psychiatric illnesses. Clinical evidence has shown that some form of sleep disruption is present in almost all psychiatric disorders.

“This is the first set of experiments that demonstrate that even healthy people’s brains mimic certain pathological psychiatric patterns when deprived of sleep,” Walker said. “Before, it was difficult to separate out the effect of sleep versus the disease itself. Now we’re closer to being able to look into whether the person has a psychiatric disease or a sleep disorder.”

Using functioning Magnetic Resonance Imaging (fMRI), Walker and his team found that the amygdala, which is also a key to processing emotions, became hyperactive in response to negative visual stimuli - mutilated bodies, children with tumors and other gory images - in study participants who stayed awake for 35 hours straight. Conversely, brain scans of those who got a full night’s sleep in their own beds showed normal activity in the amygdala.

“The emotional centers of the brain were over 60 percent more reactive under conditions of sleep deprivation than in subjects who had obtained a normal night of sleep,” Walker said.

The team studied 26 healthy participants aged 18 to 30, breaking them into two groups of equal numbers of males and females. The sleep-deprived group stayed awake during day 1, night 1 and day 2, while the sleep-control group stayed awake both days and slept normally during the night. During the fMRI brain scanning, which was performed at the end of day 2, each was shown 100 images that ranged from neutral to very negative. Using this emotional gradient, the researchers were able to compare the increase in brain response to the increasingly negative pictures.

Since 1998, Walker, an assistant professor of psychology at UC Berkeley and a former sleep researcher at Harvard Medical School, has been studying sleep’s impact on memory, learning and brain plasticity.

During his research, he was struck with the consistency of how graduate students in his studies would turn from affable, rational beings into what he called “emotional JELL-O” after a night without sleep. He and his assistants searched for research that would explain the effect of sleep deprivation on the emotional brain and found none, although there is countless anecdotal evidence that lack of sleep causes emotional swings.

“You can see it in the reaction of a military combatant soldier dealing with a civilian, a tired mother to a meddlesome toddler, the medical resident to a pushy patient. It’s these everyday scenarios that tell us people don’t get enough sleep.” Walker said.

The body alternates between two different phases of sleep during the night: Rapid Eye Movement (REM), when body and brain activity promote dreams, and Non-Rapid Eye Movement (NREM), when the muscles and brain rest.

“All signs point to sleep doing something for emotional regulation and emotional processing,” Walker said. “My job now is to figure out what kind of sleep.”

Source: University of California - Berkeley

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