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New “Fractional Laser” Reduces Wrinkles, Acne Scarring, Removes Tattoos

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Plastic surgeons at UT Southwestern Medical Center are using a new kind of laser that penetrates deeper into the skin to reduce wrinkles, treat pigmentation differences, and tighten surface structures.

The FDA approved the laser for only two U.S. Centers to test for general patient use, of which UT Southwestern was one. Testing has been completed by UT plastic surgeons who are now using the new carbon dioxide-based fractional laser. It combines minute focused columns of laser-induced injury with heat disposition, which reduces skin damage and aids quicker recovery tme.

"Fractional lasers are like aerating your lawn, where you have a bunch of holes in your lawn, but you have normal lawn in between. This allows for more rapid healing because intact, normal skin bridges the gap between the laser-induced injured skin," said Dr. Jeffrey Kenkel, vice chairman of plastic surgery whose research involves the effects of lasers on tissue.

Dr. Kenkel, director of the Clinical Center for Cosmetic Laser Treatment and chief of plastic surgery at the Veterans Administration Medical Center at Dallas, said the technology potentially could be one of the last decade’s biggest advancements in the laser world.

"What’s appealing about carbon dioxide lasers is that not only can you get surface and deeper skin changes, but you get heat that’s deposited into the skin resulting in improvement in wrinkles and skin tightening," said Dr. Kenkel. "We evaluate the laser on tissue that has either been removed from patients or that we plan on removing so we can determine what effect it’s going to have before we start treating patients clinically."

This latest laser was made by Lumenis Device Technologies. It has a larg arm and two heads an can be used on a wide range of conitions—wrinkle removal, acne scarring, alleviating dark pigmentation, and other conditions. UT Southwestern has more than 200 lasers available, and is a world leader in offering patients laser treatment options.

The new laser treatments are office-based procedures done on an out-patient basis, but may require some local or regional anesthetic, with recovery time related to the type of procedure. In most instances recovery is between three and five days. Depending on what’s required, procedure costs can range from $500 to $3,000 and are usually considered cosmetic.

"There are a lot of patients who would rather not have surgery and who are looking for things to improve their appearance without surgical down time," Dr. Kenkel said. "In addition, there’s a whole group of younger patients who are looking for improvement who are not necessarily in need of surgery but perhaps would benefit from some of the lesser invasive procedures that we have to offer."

Americans spent more than $12 billion last year on cosmetic procedures, involving 11.5 million surgical and nonsurgical procedures, according to the American Society for Aesthetic Plastic Surgery. Nonsurgical procedures, which include laser treatments, accounted for about 83 percent of those procedures.

Source: UT Southwestern Medical Center

Probiotics Reduces Respiratory Illness Rates in Athletes, Says Study

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A study in the British Journal of Sports Medicine finds that the rate and length of respiratory illness in distance runners is substantially cut by the probiotic Lactobacillus. The normal immune response to colds and flu can be suppressed by heavy exercise, which can leave some athletes vulnerable to them.

Twenty elite athletes took three freeze-dried capsules twice daily of the probiotic Lactobacillus fermentum or a placebo, during four months of winter training. Lactobacillus is a lactic acid bacteria that has been used in the treatment of gut infections. Treatments lasted four weeks each, interspersed by a month of nothing, so that by the end of the period all athletes had taken both the probiotic and placebo.

Respiratory tract infections were assessed, together with treadmill performance, immune response. While there was no difference in performance between between athletes taking the probiotic and placebo, athletes taking the probiotic had less that half the number of days of symptoms of the athletes taking the placebo. Specifically, respiratory symptoms while taking Lactobacillus lasted 30 days compared with 72 days for those taking the placebo. Levels of interferon gamma were doubled by the probiotic, an important element of the body’s immune response.

"Probiotics seem to increase systemic immunity, possibly by boosting the activity of T cells", say the researchers. "The potential of this probiotic to be used as a treatment to ward off illness merits further investigation", they say.

"An improvement in resistance to common illnesses constitutes an important benefit to elite athletes undertaking high level training in preparation for national and international competitions," they conclude.

Source: British Journal of Sports Medicine (First Br J Sports Med 2008; doi 10.1136/bjsm.2007.044628)

7 Simple Tips for a Good Night’s Sleep

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Studies show that your brain has to work harder to do the same amount of thinking when you’re tired as when you’re rested. "When you’re tired, thinking requires a lot more resources and you get fatigued more quickly as a result," says Dr. Philip Gehrman PhD, assistant professor of psychology at University of the Sciences in Philadelphia.

Pointing to the dangers of sleep deprivation, Dr. Gerhman mentions disasters like Three-Mile Island, Chernobyl, and the Exxon-Valdez oil spill. "A lot of the major industrial accidents of the last 100 years are at least partly attributable to people being sleep deprived," he said. Additionally, insufficient sleep can make people very irritable.

Dr. Gehrman has provided the following sleep hygiene tips:

  • Avoid caffeine after lunch. Caffeine can linger in your system for 10-12 hours.
  • Alcohol may help you fall asleep, but it keeps you at a light stage of sleep with poor quality. Even if you sleep for a while, you may not feel well rested the next day.
  • Have a wind-down period 30-60 minutes before going to bed. Do relaxing things that don’t require a lot of mental energy.
  • Your bed should not be your living room. If you make a habit of watching TV or reading in bed, your brain won’t know what is supposed to happen when you lay down to go to sleep.
  • Avoid napping excessively. Napping a lot can make it difficult to fall asleep at night.
  • Keep a consistent schedule for going to bed and waking up. This allows your body to develop a natural rhythm and can improve the quality of your sleep.
  • If you can’t fall asleep, don’t linger in bed. If you’ve been trying to fall asleep for about 15-20 minutes, whether it’s the beginning or middle of the night, you should get out of bed and do something relaxing. Then come back to bed when you feel ready to sleep.

"Another reason for getting a good night’s sleep", says Dr. Gehrman, "is that when people are sleep deprived, or only getting about six hours a night, their bodies actually enter a pre-diabetic state, meaning they’re bodies aren’t regulating its hormones in an efficient manner. So not only do you process food differently when you’re tired, in a way that is more likely to store food as fat, but you actually crave higher-fat food at the same time, so it’s kind of a double whammy."

Typically adults need between 7 and 9 hours sleep a night. Non-REM sleep enables our bodies to reenergize and restore themselves, while REM sleep is necessary for learning. "If you go to bed too late, you may miss the opportunity to have REM sleep," he said. "So if you’re not sleeping on a consistent schedule and at regular hours, then you can miss out on one or the other type of sleep."

FDA Warns of Potential Dangers of Botox and Botox Cosmetic

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The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on the FDA’s ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.

The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

The FDA is not advising health care professionals to discontinue prescribing these products. The agency is currently reviewing safety data from clinical studies submitted by the drugs’ manufacturers, as well as post-marketing adverse event reports and medical literature. After completing a review of the data, the FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions.

Early Communication from the FDA About Botox

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S.

These serious systemic adverse reactions occurred following treatment of a variety of conditions using a wide range of botulinum toxin doses. FDA is currently reviewing safety data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic and Myobloc, as well as post-marketing adverse event reports and the medical literature.

Botox (botulinum toxin type A) is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, also botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines.

Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children have not been established.

FDA is aware of the body of literature describing the use of botulinum toxins to treat limb spasticity in children and adults. The safety, efficacy and dosage of botulinum toxins have not been established for the treatment of limb spasticity of cerebral palsy or for use in any condition in children less than 12 years of age.

The current prescribing information (labeling) for Botox, Botox Cosmetic and Myobloc describes adverse reactions occurring in regions near the site of injection for each product’s approved uses, such as dysphagia (difficulty swallowing) after injections to treat cervical dystonia, or ptosis (drooping eye lids) after injections for glabellar frown lines or for strabismus and blepharospasm.

The Warnings sections of the labeling for both botulinum toxin products note that important systemic adverse effects, including severe difficulty swallowing and difficulty breathing have occurred in patients with neuromuscular disorders after local injection of typical doses of botulinum toxin. FDA now has evidence that similar, potentially life-threatening systemic toxicity from the use of botulinum toxin products can also result after local injection in patients with other underlying conditions such as those with cerebral palsy associated limb spasticity. Systemic toxicity has been reported in children, several of whom required feeding tubes and/or ventilation (breathing) support.

Until such time that FDA has completed its review, healthcare professionals who use medicinal botulinum toxins should:

  • Understand that potency determinations expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not comparable from one botulinum product to the next
  • Be alert to the potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress
  • Understand that these effects have been reported as early as one day and as late as several weeks after treatment
  • Provide patients and caregivers with the information they need to be able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin
  • Tell patients they should receive immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness

What does FDA know now about these data?

The FDA has reviewed post-marketing cases from its Adverse Event Reporting System (AERS) database and from the medical literature of pediatric and adult patients diagnosed with botulism following a local injection with a marketed botulinum toxin product.

The pediatric botulism cases occurred in patients less than 16 years old, with reported symptoms ranging from dysphagia to respiratory insufficiency requiring gastric feeding tubes and ventilatory support. Serious outcomes included hospitalization and death. The most commonly reported use of botulinum toxin among these cases was treatment of limb muscle spasticity associated with cerebral palsy. For Botox, doses ranged from 6.25 to 32 Units/kilogram (U/kg) in these cases. For Myobloc, reported doses were from 388 to 625 U/kg.

The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis. Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities. Among the adult cases that were serious, including hospitalization, none required intubation or ventilatory support. No deaths were reported. The doses for Botox ranged from 100 to 700 Units and for Myobloc from 10,000 to 20,000 U.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will communicate to the public its conclusions, resulting recommendations, and any regulatory actions after the review of the data are completed.

Report serious adverse events to FDA’s MedWatch reporting system by completing a form on line at http://www.fda.gov/medwatch/report/hcp.htm, by faxing (1-800-FDA-0178), by mail using the postage-paid address form provided online (5600 Fishers Lane, Rockville, MD 20853-9787),
or by telephone (1-800-FDA-1088)

Source: U.S. Food and Drug Administration (FDA)

Generic Fosamax Approved for Osteoporosis Treatment

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The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of a person’s bones.

Teva Pharmaceuticals USA, North Wales, Pa., was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths (5 milligrams, 10 milligrams, and 40 milligrams) and two once-weekly dosing strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., Montvale, N.J., was approved to manufacture a 70 milligrams once-weekly dose of the drug.

"The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA’s Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."

Fosamax is among the top 100 most frequently dispensed drugs in the United States, according to the trade magazine Drug Topics.

Generic drug manufacturers must demonstrate that a generic drug has the same active ingredient, dosage form, strength, route of administration, quality and performance characteristics, among other things, as the approved brand-name drug.

The labeling of the generic alendronate sodium tablets may differ from that of Fosamax because some portions of the labeling are protected by patents and exclusivity.

Source: FDA, February 6, 2008

Study Suggests Folate Deficiency Increases Dementia Risk Three-Fold

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Recent research suggests that the risk of dementia in elderly people is increased three times by a lack of folate.

518 people were monitored for the development of dementia during the years 2001 through 2003. All subjects were aged 65 and over and lived in either a rural or urban community in the southern part of the country. Tests were carried out at the beginning and end of the 2-year period to check for any dementing illnesses. Blood tests were also conducted to measure levels of folate, vitamin B12, and the protein homocysteine, and how these changed over time. High levels of homocysteine have been associated with cardiovascular disease.

At the beginning of 2001, almost 20% of people monitored hd high levels of homocysteine, 3.5% were folate deficient, and 17% had low vitamin B12 levels.The higher the beginning levels of folate, the higher were vitamin B12 levels, and the lower were those of homocysteine.

By the end of 2003, 45 people had developed dementia, and of these 34 had Alzheimer’s disease, 7 had vascular dementia and 4 had other types of dementia. It was observed that dementia was more probable in the older, poorly educated and inactive subjects, and among those who had deposits of th protein ApoE.

People whose folate levels fell during the 2-year period were significantly more likely to develop dementia, while their homocysteine levels rose. People who were folate deficient to begin with, were almost 3.5 times more likely to develop dementia.

The research was published in the Journal of Neurology Neurosurgery and Psychiatry.

Source: J Neurol Neurosurg Psychiatry 2008; doi 10.1136/jnnp.2007.131482

Industry Standards Needed for Children’s Flu Vaccine, Says Report

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Evaluating and establishing industry standards for flu vaccines for hospitalized children could help prevent additional hospitalizations and complications from influenza, according to a study published in a recent issue of Pediatrics.

A research team led by Danielle M. Zerr, MD, MPH, medical director of infection control at Seattle Children’s Hospital and associate professor of Pediatrics at the University of Washington School of Medicine (UWSOM), monitored the number of times children with influenza had been hospitalized, and summarized their findings in an article entitled "Hospital-Based Influenza Vaccination of Children: An Opportunity to Prevent Subsequent Hospitalization."

It was found that 23% of the children admitted to hospital with influenza had a previous hospitalization during the most recent flu season. This suggests that providing in-hospital vaccinations when the children were at highest risk for influenza could reduce the rates of childrens’ influenza during the flu season.

Approximately 14,000 children were hospitalized with influenza—and 170,000 were hospitalized with influenza or a respiratory illness—during a 5-year period (2001–2006) when discharge data provided by the Pediatric Health Information System (PHIS) database was analyzed. The data was checked to see how many children had a previous hospitalization during the most recent flu season.

Researchers found approximately 16% of those hospitalized with influenza and 23% of those hospitalized with influenza and another underlying condition had previous hospital admissions during the vaccination season.

"This information will help pediatricians recognize hospitalization as an important opportunity to vaccinate the highest-risk children, and may hopefully prompt the development of hospital-based flu vaccine programs," said Zerr.

The study looked at five years of hospital discharge data from the Pediatric Health Information System (PHIS) database from 2001 through 2006 to determine how many children hospitalized with influenza or respiratory illness had a previous hospitalization during the most recent flu-vaccine season. PHIS is an administrative database developed by the Child Health Corporation of America (CHCA), used by 42 free-standing pediatric hospitals. Subjects included newborns through age 18. A previous hospitalization during flu vaccination season was considered if it occurred in the two weeks to six months prior to the influenza admission and between September 1 and March 1. Approximately 14,000 cases of children hospitalized with influenza and 170,000 hospitalized with influenza or a respiratory illness were reviewed.

Source: Pediatrics, February, 2008

Lung Cancer Patient Response to Treatment May Be Predicted by Biomarkers

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Researchers at UCLA’s Jonsson Center, led by Dr. Steven Dubinett, have discovered biomarkers capable of predicting the response to a combination treatment by Celebrex and Tarceva by patients with advanced non-small cell lung cancer.

It is believed that these findings may help oncologists avoid prescribing conventional treatments that don’t work, in favor of drugs to which they know patients will respond.

In 2008 more than 213,000 Americans will be diagnosed with lung cancer, and of these some 160,000 will die. If further studies confirm the findings of this first study, said Dr. Steven Dubinett, a professor of pulmonary and critical care medicine and senior author, this personalized drug therapy would offer a much-needed alternative therapy. "We need good predictors of response to targeted therapy in lung cancer so individual patients receive the specific therapy that targets the particular molecular abnormalities of their tumors," he said.

The Phase 1 dose-escalation study of the drug combination surveyed a group of patients for whom all other treatments had been unsuccessful. The tumors in 50% of the patients decreased by more than 30%, or had tumors that did not grow—described as stable disease.

When the UCLA team analyzed tumor, blood and urine samples to find out why some patients did so well, they found several biomarkers that could help identify patients likely to respond to the combination Celebrex and Tarceva therapy. The answer appeared to be in the levels of certain proteins in the patients’ blood: Dubinett said that changes in these proteins may help explain the potential benefit of Celebrex in making the tumor cells more vulnerable to Tarceva.

Cycloxygenase-2 (COX-2) is an enzyme that makes cancer cells resistant to death, and causes resistance to drugs like Tarceva, allowing the cancer to grow.

Dr. Dubinett and his team found that if they inhibited the COX-2 pathway, they could restore the sensitivity of lung cancer tumor cells to Tarceva. The samples from Phase 1 patients showed that patients with low levels of MMP9 before treatment responded best to the combination therapy.

If these findings are confirmed in larger studies, in the future that protein biomarker could be used to place patients into groups with patients having low blood levels of MMP9 receiving the Celebrex and Tarceva therapy and responding. A larger, multi-site Phase 11 study of 10 patients is now under way, to confirm if there is a connection between tumors that express the proteins named in the Phase 1 study and a response to combination treatment.

"This study cold determine whether these biomarkers can be used in the future before treatment to select the patients likely to respond," said Dr. Dubinett.

The findings of the study were published in the February 1, 2008 issue of the Journal of Thoracic Oncology.

Source: University of California Los Angeles (UCLA), Health Sciences

FDA Warns of Possible Neuropsychiatric Side Effects to Pfizer’s Anti-Smoking Drug, Chantix (varenicline)

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The U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Prfizer’s anti-smoking drug, Chantix (varenicline). The FDA’s "Early Communication" advises that the agency is evaluating adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

As the agency’s review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products’ lifecycles to keep health care professionals and patients informed of new and emerging safety data.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said Bob Rappaport, M.D., director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. "While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug."

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug’s approval.

Health care professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor.

Vivid, unusual, or strange dreams may occur while taking Chantix.

Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA’s continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency’s continuing reviews and conclusions warrant.

Source: FDA, February 1, 2008

Diabetes On Increase Among Older Americans

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The number of Americans aged 65 and older diagnosed with diabetes increased by 23% between 1994-1995 and, and 2003-2004.

"The prevalence of diabetes mellitus is increasing, in part because of population aging, but also in younger persons," the report notes. The high rate of existing diabetes also contributes to a high rate of diabetes-related complications and premature death. According to the authors, "awareness of the importance of active monitoring and management of diabetes has become more widespread; however, adherence to recommended practices remains low."

Medicare data for patients diagnosed with diabetes during 1964 (33,164), 1999 (931,722) and 2003 (40,058) was analyzed by Dr. Frank A. Sloan, Ph.D., and colleagues at the Duke University Medical Center, Durham, North Carolina. A comparison of this data was run with that of two control groups made up of people without diabetes but of similar race and ethnicity to those with the disease. Death and complications associated with diabetes such as cardiovascular, cerebrovascular, ophthalmic, renal, and lower extremities were recorded.

"The annual incidence of diabetes increased by 23 percent between 1994 to 1995 and 2003 to 2004, and prevalence increased by 62 percent," the authors write. The death rate after diagnosis decreased by 8.3% compared with people who did not have the disease.

"Complication rates among persons diagnosed as having diabetes generally increased or stayed the same compared with those in the control groups during 1994 to 2004 except for ophthalmic diseases associated with diabetes," the authors note. "In some cases, most notably renal events, including the most serious complications, there were increases in prevalence in both the diabetes and control groups."

The authors emphasized that diabetes created a 90% adverse outcome, with coronary heart failure, heart attack, and stroke prevalent, concluding that the problem of providing medical care for people over 65 with diagnosed diabets and paying for it, is growing rapidly.

Source: Archives of Internal Medicine, January 29, 2008