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
Tuesday, December 7, 2010
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
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