You shouldn't use the oral or rectal routes to measure the temperature of children aged 0-5 years
In children aged 4 weeks to 5 years, you should measure body temperature by one of the following methods:
Electronic thermometer in the axilla
Chemical dot thermometer in the axilla
Infrared tympanic thermometer.
Children in the following categories are in a high risk group for serious illness:
Children younger than 3 months of age with a temperature of 38ºC or higher
Children aged 3-6 months with a temperature of 39ºC or higher
Antipyretic agents do not prevent febrile convulsions and should not be used specifically for this purpose
2: Summary table for symptoms and signs suggestive of specific diseases
Diagnosis to be considered Symptoms and signs in conjunction with fever
Meningococcal disease Non-blanching rash, particularly with one or more of the following:
An ill looking child
Lesions larger than 2 mm in diameter (purpura)
A capillary refill time of ≥3 seconds
Neck stiffness.
Meningitis One or more of the following:
Neck stiffness
Bulging fontanelle
Decreased level of consciousness
Convulsive status epilepticus.
Herpes simplex encephalitis Herpes simplex encephalitis should be considered in children with fever and any of the following features:
Focal neurological signs
Focal seizures
Decreased level of consciousness
Pneumonia You should consider pneumonia in children with fever and any of the following signs:
Tachypnoea
(RR > 60 breaths per minute Age 0-5 months,
RR > 50 breaths per minute Age 6-12 months;
RR > 40 breaths per minute Age >12 months)
Crackles
Nasal flaring
Chest indrawing
Cyanosis
Oxygen saturation ≤95% on air.
Urinary tract infection You should think of a urinary tract infection in a child aged 3 months and older with fever and one or more of the following:
Vomiting
Poor feeding
Lethargy
Irritability
Abdominal pain or tenderness
Urinary frequency or dysuria
Offensive urine or haematuria.
Septic arthritis Septic arthritis/osteomyelitis should be considered in children with fever and any of the following signs:
Swelling of a limb or joint
Not using an extremity
Non-weight bearing.
Kawasaki disease Fever for more than five days and at least four of the following:
Bilateral conjunctival injection
Change in mucous membranes (for example, injected pharynx, dry cracked lips, or strawberry tongue)
Change in the extremities (for example, oedema, erythema, or desquamation)
Polymorphous rash
Cervical lymphadenopathy.
Healthcare professionals should be aware that, in rare cases, incomplete/atypical Kawasaki disease may be diagnosed with fewer features
Monday, December 13, 2010
Friday, December 10, 2010
Antipsychotics Increase Risks for Sudden Cardiac Death
Antipsychotic drugs — both typical and atypical — carry significant risks for sudden cardiac death, and their use in some patients should be sharply reduced, according to a study and editorial in the New England Journal of Medicine.
Using 16 years of Tennessee Medicaid data, researchers retrospectively examined rates of sudden cardiac death occurring in the community in the following groups: patients currently taking typical antipsychotic drugs, patients taking atypical antipsychotics, and controls.
The principal findings were:
Current users of both typical and atypical antipsychotics showed a doubling in risk for sudden death relative to controls.
Risk increased with increasing dose among current users.
Former users showed no increased risk relative to controls.
Editorialists conclude that, especially among children and demented elderly patients for whom there is little evidence of the drugs' efficacy, their use "should be reduced sharply."
Using 16 years of Tennessee Medicaid data, researchers retrospectively examined rates of sudden cardiac death occurring in the community in the following groups: patients currently taking typical antipsychotic drugs, patients taking atypical antipsychotics, and controls.
The principal findings were:
Current users of both typical and atypical antipsychotics showed a doubling in risk for sudden death relative to controls.
Risk increased with increasing dose among current users.
Former users showed no increased risk relative to controls.
Editorialists conclude that, especially among children and demented elderly patients for whom there is little evidence of the drugs' efficacy, their use "should be reduced sharply."
Patients with Alzheimer Disease on Antipsychotics Show Increased Mortality
Patients with Alzheimer disease who take antipsychotic drugs may be at increased long-term risk for death, according to a study published online in Lancet Neurology.
Some 170 patients with Alzheimer disease who lived in long-term care facilities were randomized to either continue treatment on antipsychotics (most commonly risperidone and haloperidol) or switch to a placebo for 12 months. The group continuing antipsychotics had a significantly lower survival rate over 54 months' follow-up, compared with the placebo group (hazard ratio, 0.58). (In June 2008, the FDA mandated that antipsychotics carry boxed warnings alerting physicians to the mortality risk.)
The authors conclude: "The accumulating safety concerns, including the substantial increase in long-term mortality, emphasize the urgent need to put an end to unnecessary and prolonged prescribing."
An accompanying commentary suggests that if antipsychotics are necessary, they should be given in low doses for short durations, with regular attempts at discontinuation.
Some 170 patients with Alzheimer disease who lived in long-term care facilities were randomized to either continue treatment on antipsychotics (most commonly risperidone and haloperidol) or switch to a placebo for 12 months. The group continuing antipsychotics had a significantly lower survival rate over 54 months' follow-up, compared with the placebo group (hazard ratio, 0.58). (In June 2008, the FDA mandated that antipsychotics carry boxed warnings alerting physicians to the mortality risk.)
The authors conclude: "The accumulating safety concerns, including the substantial increase in long-term mortality, emphasize the urgent need to put an end to unnecessary and prolonged prescribing."
An accompanying commentary suggests that if antipsychotics are necessary, they should be given in low doses for short durations, with regular attempts at discontinuation.
Tuesday, December 7, 2010
American College of Preventive Medicine Does Not Recommend Prostate Cancer Screening With DRE, PSA
February 5, 2008 — Information is not adequate to recommend screening men for prostate cancer with digital rectal examination or measurement of prostate-specific antigen (PSA), according to a position statement by the American College of Preventive Medicine (ACPM) published in the February issue of the American Journal of Preventive Medicine.
"Prostate cancer is the leading cancer in U.S. men, and the third leading cause of cancer deaths," write Lionel S. Lim, MD, MPH, FACP, from the Griffin Hospital (Lim) in Derby, Connecticut, and colleagues from the ACPM Prevention Practice Committee. "Principal screening tests for detection of asymptomatic prostate cancer include digital rectal examination (DRE) and measurement of the serum tumor marker, prostate-specific antigen (PSA). There are risks and benefits associated with prostate cancer screening."
Although randomized controlled trials (RCTs) of screening for prostate cancer with digital rectal examination and PSA are limited to 2 previously published studies, 2 additional large-scale RCTs are currently ongoing. This review evaluated the efficacy of digital rectal examination and PSA for prostate cancer screening based on medical literature published before July 2007.
In clinical practice, applications of PSA screening tests include (1) a PSA cutoff value of 4 ng/mL, (2) age-specific PSA, (3) PSA velocity, (4) PSA density, and (5) percent free PSA.
Although prostate cancer screening can diagnose the disease in its early stages, thereby potentially decreasing morbidity and mortality, the benefits of prostate cancer screening remain unproved, pending findings from RCTs currently in progress. At present, no conclusive data demonstrate that early screening, detection, and treatment reduce mortality.
Other suggested potential benefits of screening include reassurance of being at low risk for prostate cancer and the fact that PSA can be easily obtained with a simple blood test and is widely available.
Potential harms of screening for prostate cancer include potential adverse health effects associated with false-positive and negative results and adverse effects of treatment. Other limitations of screening are that a survival benefit from prostate cancer screening has not been proved in rigorous trials.
A false-positive result from prostate cancer screening could lead to increased anxiety, as well as the discomfort and possible complications of biopsy, such as pain, hematospermia, hematuria, or infection. Conversely, false reassurance from a false-negative test could delay the diagnosis of prostate cancer.
Even for true-positive screening results, there may be harms because prostate cancer may be slow growing, never advancing, or progress to cause significant disease or death and because of short-term and long-term adverse effects of treatment, such as pain, urinary incontinence, and impotence.
"The American College of Preventive Medicine concludes that there is insufficient evidence to recommend routine population screening with DRE or PSA," the review authors write. "Clinicians caring for men, especially African-American men and those with positive family histories, should provide information about potential benefits and risks of prostate cancer screening, and the limitations of current evidence for screening, in order to maximize informed decision making."
The ACPM agrees with the American College of Physicians that informed discussion about screening should take place annually, during the routine periodic examination, or in response to a request by the patient.
The American Urological Association recommends that men who are 50 years and older and who have an estimated life expectancy of more than 10 years should be offered PSA screening. The American Cancer Society recommends that men who are 50 years and older and who have a life expectancy of more than 10 years should be offered both DRE and PSA screening. The Canadian Task Force on Preventive Health Care recommends against routine screening with PSA.
"The effectiveness of prostate cancer screening is questionable in elderly men with competing comorbidities and men with life expectancies of less than 10 years," the review authors note. "Ultimately, a man should be allowed to make his own choice about screening, in consultation with his physician, taking into consideration personal preferences and life expectancy. If the patient prefers to defer to the clinician or is unable to make a decision regarding screening, then testing should not be offered as long as the patient understands the benefits, potential limitations, and adverse effects associated with screening."
In men at average risk for prostate cancer, the usual age for screening is between 50 and 70 years. However, those who are at high risk might benefit from earlier screening starting at age 45 years, and higher-risk men with 2 or more first-degree relatives with prostate cancer before age 65 years might begin screening at age 40 years.
"Granted that prostate cancer is more likely to be found in high-risk men, issues pertaining to tumor grade have yet to be resolved (that is, optimal grade of tumor that a screening test should detect to confer a benefit in survival or morbidity), and there is still no evidence establishing effectiveness of screening in high-risk men," the review authors conclude. "In the meantime, further studies are needed to establish the efficacy and optimal age at which prostate cancer screening should be initiated in these high-risk population groups."
According to the American Cancer Society, no major scientific or medical organization supports routine testing for prostate cancer at this time.
The review authors have disclosed no relevant financial relationships.
Am J Prev Med. 2008;34:164-170.
"Prostate cancer is the leading cancer in U.S. men, and the third leading cause of cancer deaths," write Lionel S. Lim, MD, MPH, FACP, from the Griffin Hospital (Lim) in Derby, Connecticut, and colleagues from the ACPM Prevention Practice Committee. "Principal screening tests for detection of asymptomatic prostate cancer include digital rectal examination (DRE) and measurement of the serum tumor marker, prostate-specific antigen (PSA). There are risks and benefits associated with prostate cancer screening."
Although randomized controlled trials (RCTs) of screening for prostate cancer with digital rectal examination and PSA are limited to 2 previously published studies, 2 additional large-scale RCTs are currently ongoing. This review evaluated the efficacy of digital rectal examination and PSA for prostate cancer screening based on medical literature published before July 2007.
In clinical practice, applications of PSA screening tests include (1) a PSA cutoff value of 4 ng/mL, (2) age-specific PSA, (3) PSA velocity, (4) PSA density, and (5) percent free PSA.
Although prostate cancer screening can diagnose the disease in its early stages, thereby potentially decreasing morbidity and mortality, the benefits of prostate cancer screening remain unproved, pending findings from RCTs currently in progress. At present, no conclusive data demonstrate that early screening, detection, and treatment reduce mortality.
Other suggested potential benefits of screening include reassurance of being at low risk for prostate cancer and the fact that PSA can be easily obtained with a simple blood test and is widely available.
Potential harms of screening for prostate cancer include potential adverse health effects associated with false-positive and negative results and adverse effects of treatment. Other limitations of screening are that a survival benefit from prostate cancer screening has not been proved in rigorous trials.
A false-positive result from prostate cancer screening could lead to increased anxiety, as well as the discomfort and possible complications of biopsy, such as pain, hematospermia, hematuria, or infection. Conversely, false reassurance from a false-negative test could delay the diagnosis of prostate cancer.
Even for true-positive screening results, there may be harms because prostate cancer may be slow growing, never advancing, or progress to cause significant disease or death and because of short-term and long-term adverse effects of treatment, such as pain, urinary incontinence, and impotence.
"The American College of Preventive Medicine concludes that there is insufficient evidence to recommend routine population screening with DRE or PSA," the review authors write. "Clinicians caring for men, especially African-American men and those with positive family histories, should provide information about potential benefits and risks of prostate cancer screening, and the limitations of current evidence for screening, in order to maximize informed decision making."
The ACPM agrees with the American College of Physicians that informed discussion about screening should take place annually, during the routine periodic examination, or in response to a request by the patient.
The American Urological Association recommends that men who are 50 years and older and who have an estimated life expectancy of more than 10 years should be offered PSA screening. The American Cancer Society recommends that men who are 50 years and older and who have a life expectancy of more than 10 years should be offered both DRE and PSA screening. The Canadian Task Force on Preventive Health Care recommends against routine screening with PSA.
"The effectiveness of prostate cancer screening is questionable in elderly men with competing comorbidities and men with life expectancies of less than 10 years," the review authors note. "Ultimately, a man should be allowed to make his own choice about screening, in consultation with his physician, taking into consideration personal preferences and life expectancy. If the patient prefers to defer to the clinician or is unable to make a decision regarding screening, then testing should not be offered as long as the patient understands the benefits, potential limitations, and adverse effects associated with screening."
In men at average risk for prostate cancer, the usual age for screening is between 50 and 70 years. However, those who are at high risk might benefit from earlier screening starting at age 45 years, and higher-risk men with 2 or more first-degree relatives with prostate cancer before age 65 years might begin screening at age 40 years.
"Granted that prostate cancer is more likely to be found in high-risk men, issues pertaining to tumor grade have yet to be resolved (that is, optimal grade of tumor that a screening test should detect to confer a benefit in survival or morbidity), and there is still no evidence establishing effectiveness of screening in high-risk men," the review authors conclude. "In the meantime, further studies are needed to establish the efficacy and optimal age at which prostate cancer screening should be initiated in these high-risk population groups."
According to the American Cancer Society, no major scientific or medical organization supports routine testing for prostate cancer at this time.
The review authors have disclosed no relevant financial relationships.
Am J Prev Med. 2008;34:164-170.
Vitamin D Deficiency Associated with Increased MI Risk in Men
Low levels of vitamin D in men are associated with double the risk for myocardial infarction, reports Archives of Internal Medicine.
Researchers assessed plasma 25-hydroxyvitamin D concentrations in some 18,000 men aged 40 to 75. After 10 years, roughly 450 men had had a nonfatal MI or fatal coronary artery disease. This group was matched to a control group (from among the participants) free of cardiovascular disease.
Men who had deficient vitamin D levels (15 ng/mL or less) were at significantly higher risk for MI by follow-up, compared with men whose levels were at least 30 ng/mL (relative risk, 2.4). The results remained significant after adjustment for cardiovascular risk factors and lipid levels.
The authors propose several possible mechanisms for the association — among them, vitamin D's effects on vascular smooth muscle cell growth, vascular calcification, inflammation, and blood pressure (through the renin-angiotensin system).
Researchers assessed plasma 25-hydroxyvitamin D concentrations in some 18,000 men aged 40 to 75. After 10 years, roughly 450 men had had a nonfatal MI or fatal coronary artery disease. This group was matched to a control group (from among the participants) free of cardiovascular disease.
Men who had deficient vitamin D levels (15 ng/mL or less) were at significantly higher risk for MI by follow-up, compared with men whose levels were at least 30 ng/mL (relative risk, 2.4). The results remained significant after adjustment for cardiovascular risk factors and lipid levels.
The authors propose several possible mechanisms for the association — among them, vitamin D's effects on vascular smooth muscle cell growth, vascular calcification, inflammation, and blood pressure (through the renin-angiotensin system).
Prednisolone, Naproxen Equivalent Against Gout
Corticosteroids are just as effective against acute gout as naproxen, according to a Lancet study.
Dutch researchers randomized 120 patients with monoarticular gout to either naproxen or prednisolone for 5 days. (Gout was confirmed in all patients by the presence of monosodium urate crystals.) After 90 hours' treatment, pain and general disability scores as measured on a visual analogue scale were reduced to a similar extent in both groups.
The authors say their study "provides a strong argument to consider prednisolone as a first treatment option in patients with gout."
Dutch researchers randomized 120 patients with monoarticular gout to either naproxen or prednisolone for 5 days. (Gout was confirmed in all patients by the presence of monosodium urate crystals.) After 90 hours' treatment, pain and general disability scores as measured on a visual analogue scale were reduced to a similar extent in both groups.
The authors say their study "provides a strong argument to consider prednisolone as a first treatment option in patients with gout."
Alpha-Blocker Does Not Ease Symptoms of Chronic Prostatitis
Alfuzosin, an alpha-adrenergic–receptor blocker, does not improve symptoms in men with chronic prostatitis–chronic pelvic pain syndrome, according to a New England Journal of Medicine study.
Some 270 men who were diagnosed with the condition within the preceding 2 years and had never used an alpha-blocker were randomized to receive alfuzosin or a placebo daily for 12 weeks. By the end of treatment, approximately half of the men in each group had achieved clinically significant reductions in a symptom score measuring pain, voiding problems, and quality of life. Similarly, there were no significant differences between the groups in secondary outcomes, such as anxiety and depression.
The authors note that several meta-analyses have led some researchers to recommend alpha-blockers for chronic prostatitis. They conclude: "Our trial does not support these recommendations and should prompt reconsideration of the choice of initial therapy for these patients
Some 270 men who were diagnosed with the condition within the preceding 2 years and had never used an alpha-blocker were randomized to receive alfuzosin or a placebo daily for 12 weeks. By the end of treatment, approximately half of the men in each group had achieved clinically significant reductions in a symptom score measuring pain, voiding problems, and quality of life. Similarly, there were no significant differences between the groups in secondary outcomes, such as anxiety and depression.
The authors note that several meta-analyses have led some researchers to recommend alpha-blockers for chronic prostatitis. They conclude: "Our trial does not support these recommendations and should prompt reconsideration of the choice of initial therapy for these patients
Vapor Rub May Help Relieve Kids' Cold Symptoms
NEW YORK (Reuters Health) Nov 08 - Vapor rub may relieve a kid's nighttime cough and nasal congestion, suggests a new study funded by Vick's, the makers of the old-fashioned topical treatment.
Most children suffer between six and 10 colds every year, according to the National Institutes of Allergy and Infectious Diseases. And parents try lots of different remedies.
"There is no evidence to support the effectiveness of any of the oral over-the-counter cough and cold medicines for kids, even though they are used by one in 10 each week," Dr. Ian M. Paul of Penn State College of Medicine, in Hershey, Pennsylvania, told Reuters Health. "The American Academy of Pediatrics has been pretty clear and consistent on this."
Evidence supporting the use of vapor rub -- a commonly used concoction containing camphor, menthol and eucalyptus oils -- has also been lacking, added Dr. Paul.
After his team's previous research concluded that common cough suppressants and antihistamines (dextromethorphan and diphenhydramine) were no more effective than placebo or honey, Dr. Paul recalled frequent queries from people curious about vapor rub:
So he and his colleagues enrolled 138 children, averaging 6 years old, and randomly assigned each kid to receive petroleum-based Vick's VapoRub, or petroleum jelly without any active ingredients, or no treatment.
Parents in the two topical treatment groups applied vapor rub under their own noses before treating their kids. This way, with parents inhaling the characteristic smell of vapor rub, they wouldn't be able to tell what treatment the child was receiving.
Parents completed surveys at enrollment in the study and within 30 minutes of waking after the one night of study treatment. Results showed that kids receiving vapor rub experienced noticeably less cough, congestion and more restful sleep than kids in the other two groups.
Parents of the vapor-rubbed kids also reported improved sleep themselves, the authors said in their paper, published online today in Pediatrics.
"Kids and their parents slept better, and sleep is such an important thing for everyone, especially for kids that have to go to school the next day and parents who have to work," said Dr. Paul.
The rub didn't seem to relieve runny noses, and it caused mild irritation in nearly half of kids. On the other hand, more serious side effects have been associated with oral over-the-counter cold medicines, ranging from tachycardia to death.
Vicks VapoRub costs about $5 for 1.75 oz. There are also generic versions available.
How the concoction relieves cold symptoms is not entirely clear. The researchers suggest that the cooling sensation of menthol triggers the perception of improved airflow. But they aren't certain just how that might translate into improved symptoms.
"Parents want to give something. Pediatricians want to recommend something," Dr. Paul said.
"I think we've given them something to try, and evidence that it works," he added. "For kids ages 2 and up vapor rub is a generally safe and effective therapy."
The entire article is available online at no charge, at the URL listed below.
Pediatrics. Posted online November 8, 2010. Abstract
Most children suffer between six and 10 colds every year, according to the National Institutes of Allergy and Infectious Diseases. And parents try lots of different remedies.
"There is no evidence to support the effectiveness of any of the oral over-the-counter cough and cold medicines for kids, even though they are used by one in 10 each week," Dr. Ian M. Paul of Penn State College of Medicine, in Hershey, Pennsylvania, told Reuters Health. "The American Academy of Pediatrics has been pretty clear and consistent on this."
Evidence supporting the use of vapor rub -- a commonly used concoction containing camphor, menthol and eucalyptus oils -- has also been lacking, added Dr. Paul.
After his team's previous research concluded that common cough suppressants and antihistamines (dextromethorphan and diphenhydramine) were no more effective than placebo or honey, Dr. Paul recalled frequent queries from people curious about vapor rub:
So he and his colleagues enrolled 138 children, averaging 6 years old, and randomly assigned each kid to receive petroleum-based Vick's VapoRub, or petroleum jelly without any active ingredients, or no treatment.
Parents in the two topical treatment groups applied vapor rub under their own noses before treating their kids. This way, with parents inhaling the characteristic smell of vapor rub, they wouldn't be able to tell what treatment the child was receiving.
Parents completed surveys at enrollment in the study and within 30 minutes of waking after the one night of study treatment. Results showed that kids receiving vapor rub experienced noticeably less cough, congestion and more restful sleep than kids in the other two groups.
Parents of the vapor-rubbed kids also reported improved sleep themselves, the authors said in their paper, published online today in Pediatrics.
"Kids and their parents slept better, and sleep is such an important thing for everyone, especially for kids that have to go to school the next day and parents who have to work," said Dr. Paul.
The rub didn't seem to relieve runny noses, and it caused mild irritation in nearly half of kids. On the other hand, more serious side effects have been associated with oral over-the-counter cold medicines, ranging from tachycardia to death.
Vicks VapoRub costs about $5 for 1.75 oz. There are also generic versions available.
How the concoction relieves cold symptoms is not entirely clear. The researchers suggest that the cooling sensation of menthol triggers the perception of improved airflow. But they aren't certain just how that might translate into improved symptoms.
"Parents want to give something. Pediatricians want to recommend something," Dr. Paul said.
"I think we've given them something to try, and evidence that it works," he added. "For kids ages 2 and up vapor rub is a generally safe and effective therapy."
The entire article is available online at no charge, at the URL listed below.
Pediatrics. Posted online November 8, 2010. Abstract
Vicks VapoRub May Cause Respiratory Distress in Infants, Animal Study Suggests
Parents may ask about a Chest study suggesting that Vicks VapoRub may act as an airway irritant in very young children.
When an 18-month-old child was brought to an emergency room in severe respiratory distress after a grandparent applied Vicks VapoRub directly under her nose, clinicians investigated whether the ointment — a mixture of camphor, menthol, and eucalyptus oil — was at fault. (The product is not recommended for application to the nostril or for children under age 2 years.)
Their studies in healthy ferrets, which have an airway anatomy similar to humans, showed that mucus secretion increased and ciliary activity decreased in the presence of the ointment.
The authors conclude that the effect "may be of little physiologic consequence in older children and adults, but in infants and small children this potentially can lead to respiratory distress."
When an 18-month-old child was brought to an emergency room in severe respiratory distress after a grandparent applied Vicks VapoRub directly under her nose, clinicians investigated whether the ointment — a mixture of camphor, menthol, and eucalyptus oil — was at fault. (The product is not recommended for application to the nostril or for children under age 2 years.)
Their studies in healthy ferrets, which have an airway anatomy similar to humans, showed that mucus secretion increased and ciliary activity decreased in the presence of the ointment.
The authors conclude that the effect "may be of little physiologic consequence in older children and adults, but in infants and small children this potentially can lead to respiratory distress."
FDA Issues Alert on Topical Anesthetics
An FDA public health advisory reminds patients and physicians of potentially serious side effects from the improper use of topical anesthetics, including lidocaine, tetracaine, benzocaine, and prilocaine.
The latest advisory was prompted by a small study that tested whether lidocaine reduced discomfort during breast mammography. No serious adverse events were noted. However, the FDA remains concerned about the potential for seizures, irregular heartbeat, and breathing problems when topical anesthetics are applied over a large area or are covered by plastic wrap or a heating pad. Two deaths were previously reported in women using the anesthetics before laser hair removal.
The FDA urges patients to use the products sparingly in the weakest effective formulations
The latest advisory was prompted by a small study that tested whether lidocaine reduced discomfort during breast mammography. No serious adverse events were noted. However, the FDA remains concerned about the potential for seizures, irregular heartbeat, and breathing problems when topical anesthetics are applied over a large area or are covered by plastic wrap or a heating pad. Two deaths were previously reported in women using the anesthetics before laser hair removal.
The FDA urges patients to use the products sparingly in the weakest effective formulations
Escitalopram and Sertraline Top Comparison of 12 Newer Antidepressants
Escitalopram and sertraline seem the best choices in starting treatment for major depression, according to a meta-analysis published online in Lancet.
Researchers analyzed 117 randomized trials — comprising some 26,000 patients — of 12 new-generation antidepressants. The drugs were evaluated for efficacy and patient acceptability at the 8-week mark.
Among the conclusions:
Escitalopram, mirtazapine, sertraline, and venlafaxine were the most efficacious.
Escitalopram and sertraline showed the "best possible balance between efficacy and acceptability."
Given cost considerations, sertraline seemed the better of the two.
An editorialist, noting that the study protocol and data set are free online, writes: "A new gold standard of reliable information has been compiled for patients to review
Researchers analyzed 117 randomized trials — comprising some 26,000 patients — of 12 new-generation antidepressants. The drugs were evaluated for efficacy and patient acceptability at the 8-week mark.
Among the conclusions:
Escitalopram, mirtazapine, sertraline, and venlafaxine were the most efficacious.
Escitalopram and sertraline showed the "best possible balance between efficacy and acceptability."
Given cost considerations, sertraline seemed the better of the two.
An editorialist, noting that the study protocol and data set are free online, writes: "A new gold standard of reliable information has been compiled for patients to review
no mortality benefit from PSA testing meta analysis
BMJ has published two studies suggesting that less routine use of prostate-specific antigen (PSA) testing for cancer screening may be beneficial.
One study — a meta-analysis of six randomized controlled trials comprising almost 400,000 participants — finds no mortality benefit from PSA testing, with or without digital rectal exam.
The other study, using blood samples from nearly 1200 Swedish men at age 60 in 1981, finds that PSA levels at age 60 correlate very closely with the risk for metastatic cancer or death from prostate cancer by age 85. In fact, levels under 1 ng/mL were associated with a low likelihood of suffering prostate cancer metastases (0.5%).
An editorialist says that "elderly men and those with low risk of disease could be tested less often, if at all."
One study — a meta-analysis of six randomized controlled trials comprising almost 400,000 participants — finds no mortality benefit from PSA testing, with or without digital rectal exam.
The other study, using blood samples from nearly 1200 Swedish men at age 60 in 1981, finds that PSA levels at age 60 correlate very closely with the risk for metastatic cancer or death from prostate cancer by age 85. In fact, levels under 1 ng/mL were associated with a low likelihood of suffering prostate cancer metastases (0.5%).
An editorialist says that "elderly men and those with low risk of disease could be tested less often, if at all."
Two Testosterone Gels Get Boxed Warning
The FDA is requiring that two prescription testosterone gels — AndroGel 1% and Testim 1% — carry boxed warnings after reports of adverse events in children who had secondary exposure to the gels.
Eight children (aged 9 months to 5 years) were inadvertently exposed to the gels through skin-to-skin contact with people using the products, which are approved for men who produce low levels of testosterone. The adverse events in children included inappropriate genital enlargement, early pubic hair growth, advanced bone age, increased libido, and aggressive behavior. Usually, these symptoms regressed when the children were no longer exposed.
To minimize the risk for secondary exposure, the FDA recommends that adults using the gels:
wash their hands after every use;
cover the application area with clothing after the gel has dried;
wash the area when skin-to-skin contact with another person is expected.
In addition, other people should not touch the application area
Eight children (aged 9 months to 5 years) were inadvertently exposed to the gels through skin-to-skin contact with people using the products, which are approved for men who produce low levels of testosterone. The adverse events in children included inappropriate genital enlargement, early pubic hair growth, advanced bone age, increased libido, and aggressive behavior. Usually, these symptoms regressed when the children were no longer exposed.
To minimize the risk for secondary exposure, the FDA recommends that adults using the gels:
wash their hands after every use;
cover the application area with clothing after the gel has dried;
wash the area when skin-to-skin contact with another person is expected.
In addition, other people should not touch the application area
False Positives Common During Cancer Screenings
Cancer screening frequently yields false positives — with resulting invasive procedures — reports Annals of Family Medicine.
Researchers studied nearly 68,500 adults, aged 55 to 74, who underwent up to 14 screenings over 3 years in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Tests included digital rectal examination plus prostate-specific antigen measurement; chest x-ray; flexible sigmoidoscopy; and cancer antigen 125 testing plus transvaginal ultrasound.
Among the findings:
The risk for having one false positive after four tests was 37% among men and 26% among women; after 14 tests, risks rose to 60% and 49%, respectively.
The risk for undergoing a false-positive–prompted invasive procedure after four tests was 17% among men and 12% among women; after 14 tests, risks were 28% and 22%, respectively.
Sigmoidoscopy accounted for the most false positives and related procedures.
The researchers conclude that providers "should educate patients about the likelihood of false positives and resulting diagnostic interventions when counseling about cancer screening."
Researchers studied nearly 68,500 adults, aged 55 to 74, who underwent up to 14 screenings over 3 years in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Tests included digital rectal examination plus prostate-specific antigen measurement; chest x-ray; flexible sigmoidoscopy; and cancer antigen 125 testing plus transvaginal ultrasound.
Among the findings:
The risk for having one false positive after four tests was 37% among men and 26% among women; after 14 tests, risks rose to 60% and 49%, respectively.
The risk for undergoing a false-positive–prompted invasive procedure after four tests was 17% among men and 12% among women; after 14 tests, risks were 28% and 22%, respectively.
Sigmoidoscopy accounted for the most false positives and related procedures.
The researchers conclude that providers "should educate patients about the likelihood of false positives and resulting diagnostic interventions when counseling about cancer screening."
Flomax Associated with Complications After Ophthalmologic Surgery
Men taking tamsulosin (Flomax) for benign prostatic hypertrophy face higher risks for intraoperative floppy iris syndrome and its complications (retinal detachment, lost lens or fragments, or endophthalmitis), according to a retrospective study in JAMA.
Researchers used Ontario health databases to examine a possible association between exposure to tamsulosin or other alpha-blocking drugs in men aged 66 or older before cataract surgery and adverse outcomes within 2 weeks after the operation. They found that men who experienced complications were more than twice as likely to have been exposed to tamsulosin (but not the other drugs) in the 2 weeks before surgery, compared with those without adverse events.
The authors calculate a number needed to harm of 255.
Tamsulosin selectively targets sites common to both bladder and iris relaxation, and the authors speculate this may be the reason for the adverse effects. An editorialist suggests that tamsulosin may require a black-box warning to caution both patients and surgeons
Researchers used Ontario health databases to examine a possible association between exposure to tamsulosin or other alpha-blocking drugs in men aged 66 or older before cataract surgery and adverse outcomes within 2 weeks after the operation. They found that men who experienced complications were more than twice as likely to have been exposed to tamsulosin (but not the other drugs) in the 2 weeks before surgery, compared with those without adverse events.
The authors calculate a number needed to harm of 255.
Tamsulosin selectively targets sites common to both bladder and iris relaxation, and the authors speculate this may be the reason for the adverse effects. An editorialist suggests that tamsulosin may require a black-box warning to caution both patients and surgeons
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Daily aspirin use confers a reduction in risk for death from several common cancers, in addition to its known benefit on colorectal cancer risk, according to a Lancet meta-analysis.
Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)
Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).
In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation
Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)
Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).
In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation
Sunday, December 5, 2010
Antidepressants Linked to Increased Risk for Death, Stroke in Postmenopausal Women
December 22, 2009 — Postmenopausal women taking either a tricyclic antidepressant (TCA) or a selective serotonin-reuptake inhibitor (SSRI) appear to be at increased risk for all-cause mortality, and SSRI users seem to be at increased risk for hemorrhagic and fatal stroke, although the absolute event risks are low, according to an analysis from the Women's Health Initiative (WHI) study.
In an article published in the December issue of the Archives of Internal Medicine, Jordan Smoller, MD, from Massachusetts General Hospital, Boston, and colleagues report that new use of either a TCA or an SSRI during a mean follow-up of 5.9 years was not significantly associated with an increased risk for coronary heart disease (CHD) in this large prospective cohort of postmenopausal women.
In contrast, compared with women who did not use antidepressants, "those using SSRIs had a 45% increased relative risk of incidence stroke and a 32% increased risk of death in models stratified on propensity and adjusted for multiple covariates," the investigators report. TCA use in turn was associated with a 67% higher relative risk for all-cause death (hazard ratio [HR], 1.67; 95% confidence interval [CI], 1.33 - 2.09). The TCAs also increase stroke risk, but not significantly so.
In an article published in the December issue of the Archives of Internal Medicine, Jordan Smoller, MD, from Massachusetts General Hospital, Boston, and colleagues report that new use of either a TCA or an SSRI during a mean follow-up of 5.9 years was not significantly associated with an increased risk for coronary heart disease (CHD) in this large prospective cohort of postmenopausal women.
In contrast, compared with women who did not use antidepressants, "those using SSRIs had a 45% increased relative risk of incidence stroke and a 32% increased risk of death in models stratified on propensity and adjusted for multiple covariates," the investigators report. TCA use in turn was associated with a 67% higher relative risk for all-cause death (hazard ratio [HR], 1.67; 95% confidence interval [CI], 1.33 - 2.09). The TCAs also increase stroke risk, but not significantly so.
Friday, December 3, 2010
Glycated Hemoglobin Better Than Fasting Glucose for Predicting Cardiovascular Risk
Glycated hemoglobin levels, especially above 6.0%, are better than fasting glucose for predicting long-term cardiovascular risk, the New England Journal of Medicine reports.
Researchers measured glycated hemoglobin and fasting glucose in some 11,000 adults without diabetes or cardiovascular disease and followed them for a median of 14 years. Compared with hemoglobin levels of 5.0% to 5.5%, higher values — especially above 6% — were associated with significantly increased risks for diabetes, coronary heart disease, and stroke. Associations between hemoglobin and all-cause mortality were also significant, but formed a J-shaped curve, with the lowest and highest levels being predictive of death.
These findings held true even after adjustment for fasting glucose.
The authors say their findings "may add to the evidence supporting the use of glycated hemoglobin as a diagnostic test for diabetes."
Researchers measured glycated hemoglobin and fasting glucose in some 11,000 adults without diabetes or cardiovascular disease and followed them for a median of 14 years. Compared with hemoglobin levels of 5.0% to 5.5%, higher values — especially above 6% — were associated with significantly increased risks for diabetes, coronary heart disease, and stroke. Associations between hemoglobin and all-cause mortality were also significant, but formed a J-shaped curve, with the lowest and highest levels being predictive of death.
These findings held true even after adjustment for fasting glucose.
The authors say their findings "may add to the evidence supporting the use of glycated hemoglobin as a diagnostic test for diabetes."
Association Found Between Vitamin E Supplements and Hemorrhagic Stroke
Vitamin E supplements have no effect on overall stroke incidence, but when stroke type is examined, the supplements significantly increase risk for hemorrhagic stroke, according to a BMJ meta-analysis.
Researchers examined data from nine trials encompassing some 120,000 subjects who'd been randomized to receive vitamin E or placebo and were followed for more than 1 year. Rates of stroke overall did not differ between groups. However, when the type of stroke was examined, ischemic strokes were significantly fewer among the vitamin recipients, while hemorrhagic strokes were significantly increased — by some 20%.
The authors say that the contrasting effects have tended to obscure vitamin E's hemorrhagic risks. They write that the mechanism behind the effect is unknown and that it may stem from vitamin E's interference with a vitamin-K-dependent clotting factor. They conclude that "indiscriminate widespread use of vitamin E should be cautioned against."
Researchers examined data from nine trials encompassing some 120,000 subjects who'd been randomized to receive vitamin E or placebo and were followed for more than 1 year. Rates of stroke overall did not differ between groups. However, when the type of stroke was examined, ischemic strokes were significantly fewer among the vitamin recipients, while hemorrhagic strokes were significantly increased — by some 20%.
The authors say that the contrasting effects have tended to obscure vitamin E's hemorrhagic risks. They write that the mechanism behind the effect is unknown and that it may stem from vitamin E's interference with a vitamin-K-dependent clotting factor. They conclude that "indiscriminate widespread use of vitamin E should be cautioned against."
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