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Wednesday, July 09, 2008
Fluoroquinolone Antimicrobial Drugs Carry Risk Of Developing Tendinitis And Tendon Rupture In Patients Taking Fluoroquinolones For Systemic Use.
[Posted 07/08/2008] FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.
[July 08, 2008 - Drug Information Page - FDA]
[July 08, 2008 - Information for Healthcare Professionals - FDA]
[July 08, 2008 - News Release - FDA]
Friday, July 04, 2008
Thursday, July 03, 2008
Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
- Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
- Audience: Orthopedic surgeons, neurosurgeons, hospital risk managers, surgical service staff
[Posted 07/02/2008] FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.
[July 01, 2008 - Public Health Notification - FDA]
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Products Marketed as Dietary Supplements, Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Recalled By Jack Distribution, LLC.
ack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that these lots of Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Recallr: Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Recalled By Jack Distribution, LLC.
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Recallr: Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Recalled By Jack Distribution, LLC.
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Wednesday, July 02, 2008
Get Smart Or Stay Smart By Selecting Right Food.
Get smart about what you eat and you might actually improve your intelligence
MIT researchers offer tantalizing evidence on how to make people smarter, naturally
New research findings published online in The FASEB Journal provide more evidence that if we get smart about what we eat, our intelligence can improve. According to MIT scientists, dietary nutrients found in a wide range of foods from infant formula to eggs increase brain synapses and improve cognitive abilities."I hope human brains will, like those of experimental animals, respond to this kind of treatment by making more brain synapses and thus restoring cognitive abilities," said Richard Wurtman, MD, senior researcher on the project.
In the study, gerbils were given various combinations of three compounds needed for healthy brain membranes: choline, found in eggs; uridine monophosphate (UMP) found in beets; and docosahexaenoic acid (DHA), found in fish oils. Other gerbils were given none of these to serve as a baseline. Then they were checked for cognitive changes four weeks later. The scientists found that the gerbils given choline with UMP and/or DHA showed cognitive improvements in tasks thought to be relevant to gerbils, such as navigating mazes. After these tests were concluded, the researchers dissected the mouse brains for a biological cause for the improvement. They found biochemical evidence that there was more than the usual amount of brain synapse activity, which was consistent with behaviors indicating higher intelligence.
"Now that we know how to make gerbils smarter," said Gerald Weissmann, MD, Editor-in-Chief of The FASEB Journal, "it's not too far a stretch to hope that people's intelligence can also be improved. Quite frankly, this can't happen soon enough, as every environmentalist, advocate of evolution and war opponent will attest."
Contact: Cody Mooneyhan
cmooneyhan@faseb.org
301-634-7104
Federation of American Societies for Experimental Biology
Tuesday, July 01, 2008
Employer-Based Weight Loss Programs Are Helpful
CINCINNATI—A new review of studies from UC shows that a little shove from the workplace may actually be the ticket to dropping weight.
According to Michael Benedict, MD, and colleagues at UC, employer-based programs for weight loss are modestly effective at helping workers take off extra pounds.
“Worksite-based programs do tend to result in weight loss for the people that participate in them,” says Benedict, co-author of the study and researcher in the department of internal medicine.
The review appears in the July-August issue of the American Journal of Health Promotion.
Benedict and colleagues looked at 11 studies published since 1994 to determine their results.
Most of the programs involved education and counseling designed to improve diet and increase physical activity and lasted anywhere from two to 18 months. Forty-six percent of the studies involved low-intensity interventions, 18 percent were moderate intensity and 36 percent were high intensity.
Benedict says that intensity may be an important factor when it comes to weight loss. He added that programs incorporating face-to-face contact with subjects more than once a month appeared to be more effective than other programs.
In comparison, participants in higher intensity programs lost an average of 2.2 pounds to almost 14 pounds, while non-participants ranged from a loss of 1.5 pounds to a gain of 1.1 pounds.
“Most employed adults in the U.S. spend nearly half of their waking hours at their place of employment,” Benedict says. “Worksite based programs have great potential to positively impact our current obesity epidemic.
However, Benedict says it was difficult to draw conclusions about weight-loss maintenance.
“Participants in these programs may lose weight, but it is unclear what happens after the fact, as weight maintenance has not been studied,” he says.
There is also minimal data to show how much money employers could save if they start worksite weight-loss programs. Benedict says many employers want to know that implementing these programs will lead to a positive return on investment.
Studies have shown that other worksite health interventions targeting high risk employees, like smokers and people with hypertension, may benefit employers financially within only a few years.
“These programs have the potential to have a tremendous public health impact,” he says. “However, more high quality research is needed.”
Michael Benedict, MD,
Media Contact: Katie Pence, (513) 558-4561
According to Michael Benedict, MD, and colleagues at UC, employer-based programs for weight loss are modestly effective at helping workers take off extra pounds.
“Worksite-based programs do tend to result in weight loss for the people that participate in them,” says Benedict, co-author of the study and researcher in the department of internal medicine.
The review appears in the July-August issue of the American Journal of Health Promotion.
Benedict and colleagues looked at 11 studies published since 1994 to determine their results.
Most of the programs involved education and counseling designed to improve diet and increase physical activity and lasted anywhere from two to 18 months. Forty-six percent of the studies involved low-intensity interventions, 18 percent were moderate intensity and 36 percent were high intensity.
Benedict says that intensity may be an important factor when it comes to weight loss. He added that programs incorporating face-to-face contact with subjects more than once a month appeared to be more effective than other programs.
In comparison, participants in higher intensity programs lost an average of 2.2 pounds to almost 14 pounds, while non-participants ranged from a loss of 1.5 pounds to a gain of 1.1 pounds.
“Most employed adults in the U.S. spend nearly half of their waking hours at their place of employment,” Benedict says. “Worksite based programs have great potential to positively impact our current obesity epidemic.
However, Benedict says it was difficult to draw conclusions about weight-loss maintenance.
“Participants in these programs may lose weight, but it is unclear what happens after the fact, as weight maintenance has not been studied,” he says.
There is also minimal data to show how much money employers could save if they start worksite weight-loss programs. Benedict says many employers want to know that implementing these programs will lead to a positive return on investment.
Studies have shown that other worksite health interventions targeting high risk employees, like smokers and people with hypertension, may benefit employers financially within only a few years.
“These programs have the potential to have a tremendous public health impact,” he says. “However, more high quality research is needed.”
Michael Benedict, MD,
Media Contact: Katie Pence, (513) 558-4561
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Does Your Weight Loss Programme Slow DOwn During Weekends?
June 30, 2008 -- Saturday can be the worst enemy for our waistlines, according to researchers at Washington University School of Medicine in St. Louis.
They found that study subjects on strict diet and exercise programs tend to lose weight more slowly than expected because they eat more on weekends than during the week. The investigators report their findings in the advance online publication of the journal Obesity.
Past research had confirmed that people tend to gain weight during the holidays, particularly between Thanksgiving and New Year's, but this is the first study to carefully monitor daily body weight, calorie intake and calorie expenditure for several weeks throughout a year, and to demonstrate that increased caloric intake isn't just a problem during the holidays. It also happens on most weekends.
"We thought weekends would present a problem for some people attempting to lose weight, but the consistency of our finding before and during the interventions was surprising," says first author Susan B. Racette, Ph.D., assistant professor of physical therapy and of medicine. "Subjects in the diet group lost weight during the week, but over the weekend, they stopped losing weight because they were eating more."
Racette's team followed 48 adults between the ages of 50 and 60 who took part in the CALERIE (Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy) study. Body mass index (BMI) ranked subjects as overweight or healthy weight when the study began. None were classified as obese.
Following earlier studies demonstrating that mice and rats live longer, healthier lives when on a calorie restricted diet, the CALERIE study is designed to determine whether taking in fewer calories over a long time period will slow down or reverse some of the common markers of aging and disease.
"But rats don't have weekends the way people do," Racette says. "On weekends, human lifestyle patterns can be very different. People have social events, parties to attend, and if they have children who play sports, they might be at fields all day long, relying on concession stands for food."
Study participants were divided into three groups: the first lowered their daily calorie intake by 20 percent, a second increased daily physical activity by 20 percent, and a third, control group did not change diet or activity levels. All three groups were monitored for one year. They kept food diaries, tracked exercise with accelerometers and were weighed regularly. Racette says people in the study didn't always realize they were eating significantly more food on weekends.
"It was surprising how consistent the findings were," she says. "We also were surprised by the dramatic way in which weekends continued to slow weight loss throughout the course of the study."
Before the interventions began, the researchers established "baselines" for each study participant's exercise and eating habits. This pre-intervention data determined that participants consumed the most calories on Saturdays. An average of 36 percent of their total calories came from fat on Saturdays, but less than 35 percent came from fat during the rest of the week. The typical weekend weight gain before the diet and exercise interventions began would have led to an average increase of 9 pounds a year.
When study participants were asked either to cut calories by 20 percent or to increase activity by a like amount, the pattern remained the same. Those in the calorie restriction group took in more energy on Saturday. Those in the exercise group ate more on both Saturday and Sunday. As a result, people in the calorie restriction group stopped losing weight on weekends, and those in the exercise group actually gained weight on weekends.
"People on diets often don't lose as much weight as we would expect, and this finding helps to explain why," she says.
As the researchers move into the second phase of the CALERIE study, looking at more subjects over a longer period of time, they now recommend that participants weigh themselves daily in order to be more aware of their patterns of weight loss and weight gain, particularly on weekends. For those not in a research study, she recommends moderation and careful planning to avoid weekend pitfalls.
"Planning ahead can't be emphasized enough," Racette says. She recommends packing healthy food if you're running errands, eating a little something so you aren't starving when you arrive at a party, even packing a light lunch before going to the kids' ballgames so that you have a choice other than junk food at a concession stand.
"In addition, she says, "paying closer attention to portion sizes can enable a person to enjoy the weekend without sabotaging weight-control efforts."
Racette SB, Weiss EP, Schechtman KB, Steger-May K, Villareal DT, Obert KA, Holloszy JO, and the Washington University School of Medicine CALERIE Team. Influence of weekend lifestyle patterns on body weight. Obesity, advance online publication doi: 10.1038/oby.2008.320
This study was supported by the National Institutes of Health.
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They found that study subjects on strict diet and exercise programs tend to lose weight more slowly than expected because they eat more on weekends than during the week. The investigators report their findings in the advance online publication of the journal Obesity.
Past research had confirmed that people tend to gain weight during the holidays, particularly between Thanksgiving and New Year's, but this is the first study to carefully monitor daily body weight, calorie intake and calorie expenditure for several weeks throughout a year, and to demonstrate that increased caloric intake isn't just a problem during the holidays. It also happens on most weekends.
"We thought weekends would present a problem for some people attempting to lose weight, but the consistency of our finding before and during the interventions was surprising," says first author Susan B. Racette, Ph.D., assistant professor of physical therapy and of medicine. "Subjects in the diet group lost weight during the week, but over the weekend, they stopped losing weight because they were eating more."
Racette's team followed 48 adults between the ages of 50 and 60 who took part in the CALERIE (Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy) study. Body mass index (BMI) ranked subjects as overweight or healthy weight when the study began. None were classified as obese.
Following earlier studies demonstrating that mice and rats live longer, healthier lives when on a calorie restricted diet, the CALERIE study is designed to determine whether taking in fewer calories over a long time period will slow down or reverse some of the common markers of aging and disease.
"But rats don't have weekends the way people do," Racette says. "On weekends, human lifestyle patterns can be very different. People have social events, parties to attend, and if they have children who play sports, they might be at fields all day long, relying on concession stands for food."
Study participants were divided into three groups: the first lowered their daily calorie intake by 20 percent, a second increased daily physical activity by 20 percent, and a third, control group did not change diet or activity levels. All three groups were monitored for one year. They kept food diaries, tracked exercise with accelerometers and were weighed regularly. Racette says people in the study didn't always realize they were eating significantly more food on weekends.
"It was surprising how consistent the findings were," she says. "We also were surprised by the dramatic way in which weekends continued to slow weight loss throughout the course of the study."
Before the interventions began, the researchers established "baselines" for each study participant's exercise and eating habits. This pre-intervention data determined that participants consumed the most calories on Saturdays. An average of 36 percent of their total calories came from fat on Saturdays, but less than 35 percent came from fat during the rest of the week. The typical weekend weight gain before the diet and exercise interventions began would have led to an average increase of 9 pounds a year.
When study participants were asked either to cut calories by 20 percent or to increase activity by a like amount, the pattern remained the same. Those in the calorie restriction group took in more energy on Saturday. Those in the exercise group ate more on both Saturday and Sunday. As a result, people in the calorie restriction group stopped losing weight on weekends, and those in the exercise group actually gained weight on weekends.
"People on diets often don't lose as much weight as we would expect, and this finding helps to explain why," she says.
As the researchers move into the second phase of the CALERIE study, looking at more subjects over a longer period of time, they now recommend that participants weigh themselves daily in order to be more aware of their patterns of weight loss and weight gain, particularly on weekends. For those not in a research study, she recommends moderation and careful planning to avoid weekend pitfalls.
"Planning ahead can't be emphasized enough," Racette says. She recommends packing healthy food if you're running errands, eating a little something so you aren't starving when you arrive at a party, even packing a light lunch before going to the kids' ballgames so that you have a choice other than junk food at a concession stand.
"In addition, she says, "paying closer attention to portion sizes can enable a person to enjoy the weekend without sabotaging weight-control efforts."
Racette SB, Weiss EP, Schechtman KB, Steger-May K, Villareal DT, Obert KA, Holloszy JO, and the Washington University School of Medicine CALERIE Team. Influence of weekend lifestyle patterns on body weight. Obesity, advance online publication doi: 10.1038/oby.2008.320
This study was supported by the National Institutes of Health.
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