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
Tuesday, December 7, 2010
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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