Mostrando las entradas con la etiqueta canada. Mostrar todas las entradas
Mostrando las entradas con la etiqueta canada. Mostrar todas las entradas

30 junio, 2013

Concurrent Macrolide Antibiotic Associated With Statin Toxicity

266
266 (Photo credit: Wikipedia)



Ann. Intern. Med. 2013 Jun 01;158(12)869-876, AM Patel, S Shariff, DG Bailey, DN Juurlink, S Gandhi, M Mamdani, T Gomes, J Fleet, YJ Hwang, AX Garg


TAKE-HOME MESSAGE

A retrospective population-based cohort study of statin users > 65 years found that concurrent clarithromycin or erythromycin use with statins increases the risk of rhabdomyolysis, acute kidney injury, and all-cause mortality. Clinicians should consider prescribing alternative macrolides, or other antibiotic classes, when patients are taking statins.


SUMMARY
PracticeUpdate Editorial Team
Background: Clarithromycin and erythromycin, but not azithromycin, inhibit cytochrome P450 isoenzyme 3A4 (CYP3A4), and inhibition increases blood concentrations of statins that are metabolized by CYP3A4.
Objective: To measure the frequency of statin toxicity after coprescription of a statin with clarithromycin or erythromycin.
Design: Population-based cohort study.
Setting: Ontario, Canada, from 2003 to 2010.
Patients: Continuous statin users older than 65 years who were prescribed clarithromycin (n = 72 591) or erythromycin (n = 3267) compared with those prescribed azithromycin (n = 68 478).
Measurements: The primary outcome was hospitalization with rhabdomyolysis within 30 days of the antibiotic prescription.
Results: Atorvastatin was the most commonly prescribed statin (73%) followed by simvastatin and lovastatin. Compared with azithromycin, coprescription of a statin with clarithromycin or erythromycin was associated with a higher risk for hospitalization with rhabdomyolysis (absolute risk increase, 0.02% [95% CI, 0.01% to 0.03%]; relative risk [RR], 2.17 [CI, 1.04 to 4.53]) or with acute kidney injury (absolute risk increase, 1.26% [CI, 0.58% to 1.95%]; RR, 1.78 [CI, 1.49 to 2.14]) and for all-cause mortality (absolute risk increase, 0.25% [CI, 0.17% to 0.33%]; RR, 1.56 [CI, 1.36 to 1.80]).
Limitations: Only older adults were included in the study. The absolute risk increase for rhabdomyolysis may be underestimated because the codes used to identify it were insensitive.

Annals of Internal Medicine
Statin Toxicity From Macrolide Antibiotic Coprescription: A Population-Based Cohort Study
Ann. Intern. Med. 2013 Jun 01;158(12)869-876, AM Patel, S Shariff, DG Bailey, DN Juurlink, S Gandhi, M Mamdani, T Gomes, J Fleet, YJ Hwang, AX Garg
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12 junio, 2013

Atomoxetina y afecciones cardiovasculares

Strattera atomoxetin
Strattera atomoxetin (Photo credit: Wikipedia)

Eli Lilly Canada Inc., en colaboración con Health Canada, está notificando a los profesionales sanitarios y pacientes nuevos datos de seguridad importantes provenientes de  estudios clínicos, en relación al riesgo de
aumento de la presión arterial y del ritmo cardíaco asociados con el uso de atomoxetina (Strattera),  que es un inhibidor selectivo de la recaptación de noradrenalina indicado para el tratamiento de síndrome de déficit de atención / hiperactividad (TDAH) en niños y adultos.
La atomoxetina puede aumentar la frecuencia cardíaca y presión arterial. Tener en cuenta las siguientes recomendaciones:
a.. La atomoxetina está contraindicada en pacientes  con enfermedad cardiovasculares sintomática, hipertensión moderada a severa o alteraciones cardiovasculares graves cuya condición se espera que se deteriore si se
experimentaron aumentos en la presión arterial o del ritmo cardíaco que pueden ser clínicamente importantes.

 b.. Atomoxetina debe usarse con precaución en pacientes cuya patología subyacente podría empeorar por el aumento de la presión arterial o de la frecuencia cardiaca, como pacientes con hipertensión, taquicardia o
enfermedad cardiovascular o cerebrovascular.

 c.. Atomoxetina debe usarse con precaución en pacientes con síndrome de QT largo congénita o adquirida, o un historial familiar de prolongación del intervalo QT.

 d.. Antes de iniciar el tratamiento con atomoxetina y durante el seguimiento del curso del tratamiento, los pacientes deben ser evaluados para investigar la existencia de alteraciones cardiovasculares o cerebrovasculares pre-existentes o subyacentes.

 e.. Se recomienda medir  la frecuencia cardiaca y presión arterial  en todos los pacientes antes del inicio del tratamiento con atomoxetina, después de aumentar la dosis, y periódicamente durante el tratamiento para
detectar posibles aumentos clínicamente importantes, en particular durante los primeros meses de la terapia.

Un reciente análisis de datos combinados de ensayos clínicos controlados y no controlados, patrocinados por Eli Lilly han indicado que, aproximadamente el 25% de los 8417 los pacientes pediátricos tratados con atomoxetina,
experimentó un aumento de la presión arterial de 10 mmHg y 5,8% un aumento de 20 mmHg, mientras que se registro un aumento de la frecuencia de 10 latidos por minuto (lpm) en el 33% de los pacientes y de 20 lpm en el 12% de los pacientes. Estos  aumentos podrían representar un riesgo para algunos pacientes. En  pacientes adultos con TDAH se ha observado aumento de la presión arterial y del ritmo cardíaco  en una proporción similar

La monografía del producto canadiense de Stratteraha sido revisada.



Fuente: Martin Cañas. Lista Drugs in spanish
recientemente para incluir estos nuevos hallazgos importantes de seguridad.
Una copia de la monografía de producto más actualizada se puede encontrar
en: http://webprod3.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp


Fuente:
Health Canada. STRATTERA (atomoxetine) - Association with Increased Blood
Pressure and Increased Heart Rate - For Health Professionals. October 21,
2011
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/strattera_2_hpc-cps-eng.php

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27 mayo, 2013

A call to challenge the “Selling of Sickness”

BMJ
BMJ (Photo credit: Wikipedia)
  Source: Editorial in BMJ

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2809 (Published 14 May 2013)
Cite this as: BMJ 2013;346:f2809
  1. Leonore Tiefer, convenor, New View Campaign1,
  2. Kim Witczak, co-founder, WoodyMatters2,
  3. Iona Heath, immediate past president3
Author Affiliations
  1. ltiefer@mindspring.com
A partnership model for a new social health movement
The sense that medicine is out of control is generating a rising tide of concern that includes the BMJ’s Too Much Medicine campaign.1 Throughout history, unscrupulous people have preyed on our universal fears of suffering and death and made money by selling dubious remedies. The hope that the growing scientific foundation for medical practice would consign such activity to historical oblivion has proved to be a vain one. Indeed, contemporary enthusiasm for the commercialization and marketing of healthcare seems to offer ever wider opportunities to sell medical treatments. The results of medical research are often distorted or suppressed for commercial gain, and systems that attempt to control clinicians’ behaviour through payment by results drive overdiagnosis and overtreatment.2 3 Patients experience well documented harms as more and more often financial imperatives are allowed to trump clinical judgment.4 Harm is also caused by well meaning doctors trying to save lives by diagnosing serious conditions earlier,5 which inevitably drives up overdiagnosis and overtreatment. Well meaning doctors, patients, politicians, and journalists consistently overestimate the benefits and underestimate the harms of most medical treatments.
These problems have been increasingly aired and analysed on websites, in editorials, and in dozens of recent books by investigative journalists, crusading physicians, earnest advocates, and academic reformers.6 Proposed solutions include greater regulation of the medical and scientific communities to improve accountability and to expose conflicts of interest, greater transparency in publishing and education, much greater patient involvement in decision making, and higher standards of professional integrity. Yet the fundamental problems remain and the situation seems to get worse each year.
A comprehensive social health movement that combines the perspectives and resources of healthcare professionals, patient representatives, and consumer advocates in a partnership that aims to counter overdiagnosis and overtreatment is well overdue. A partnership model that affirms themes of mutual respect and collaboration can enable questions and concerns to be raised in different voices for different audiences; can foster wider dissemination of key messages to enlarge collective action; and can generate diverse strategies to promote public awareness and policy change.
A recent international conference (www.sellingsickness.com) held in Washington, DC, brought together many different stakeholders in healthcare, including professionals and consumer advocates, to discuss how to end disease mongering and how to challenge the undue commercial influences that distort so many aspects of healthcare research and practice. This self funded grassroots conference deliberately sought to model the possibility of a new social health movement with equal representation of professional and advocate perspectives and extended time for discussion.
A “Call to Action on Selling Sickness” was developed by a diverse group over a period of months, uploaded on to the Selling Sickness conference website for preview, and opened for signatures from the final day of the conference. Among its list of concerns were the problems of biased science, hidden data, inflated diagnostic categories, unnecessary screening and treatment, and the widespread neglect of social factors when treating illness. Its recommendations included a call for a new movement of alliances and actions to “ensure a firewall between commercial influences and medical guidelines.” The campaign aims to bring an end to direct-to-consumer advertising of diagnostics and drugs, ensure appropriate testing of new drugs and devices, put forward reform of the patent system, and promote responsible health journalism. Although there was no systematic effort to obtain signatures from the more than 240 conference attendees, 35 people signed the call for action by the end of the conference. They represented nonprofit organizations, university research groups, clinical enterprises, the Public Library of Science journals, and law offices to name a few, and came from Canada, the United Kingdom, Germany, Russia, the Netherlands, New Zealand, and the United States. The call to action on Selling Sickness is now online (www.sellingsickness.com/final-statement) and open for individual and organizational endorsement.
Using professional-advocate collaborations to tackle the problem of medical overtreatment is not a new idea. In a recent project, “Choosing Wisely,” designed by the American Board of Internal Medicine together with Consumer Reports,7 medical specialty organizations identify practices prone to overuse in their specialties and partner with Consumer Reports to disseminate consumer friendly educational materials. The list of participating specialty organizations continues to grow (www.choosingwisely.com). The alltrials.net movement has used social media to stimulate publicity and now has thousands of signatures on its petition for open access to all clinical trial data (www.alltrials.net/). The Selling Sickness call to action, promoted by an emerging advocate-professional partnership, will add strength to the new social movement for healthcare reform that may prove crucial to global health in the 21st century.

Notes

Cite this as: BMJ 2013;346:f2809

Footnotes

  • Competing interests: We have read and understood the BMJ Group policy on declaration of interests and declare the following interests: None.
  • Provenance and peer review: Commissioned; not externally peer reviewed.

References

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27 abril, 2013

Safety Information and Adverse Event Reporting Program Eba Multivitamin Supplement By Saratoga Therapeutics LLC


MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Eba Multivitamin Supplement By Saratoga Therapeutics LLC: Recall - Allergy Alert On Undeclared Milk Components

AUDIENCE: Consumer, Patient, Health Professional
ISSUE: Saratoga Therapeutics, LLC of North Wales, PA recalled 900 bottles of ebA Multivitamin Supplement because they may contain undeclared milk components – milk protein(s) and lactose. The label lists the product as being free of milk components. People with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction and people who have lactose intolerance run the risk of gastrointestinal symptoms if they consume ebA Multivitamin Supplement.
Affected lot numbers include #0912164 expiration date 12/12 and #1110354 expiration date 10/14.
BACKGROUND: ebA Multivitamin Supplement was distributed nationwide and in Australia, Canada, Costa Rica, England, Finland, Ireland, Malaysia, Switzerland, and Tasmania. and reached consumers by mail order, fax order, internet sales and doctors' office sales. The vitamins are packaged in a white plastic bottle with white, green and blue labeling. The expiration date is listed beneath the Warning section on the label.

 Recall - Allergy Alert On Undeclared Milk Components

AUDIENCE: Consumer, Patient, Health Professional
ISSUE: Saratoga Therapeutics, LLC of North Wales, PA recalled 900 bottles of ebA Multivitamin Supplement because they may contain undeclared milk components – milk protein(s) and lactose. The label lists the product as being free of milk components. People with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction and people who have lactose intolerance run the risk of gastrointestinal symptoms if they consume ebA Multivitamin Supplement.
Affected lot numbers include #0912164 expiration date 12/12 and #1110354 expiration date 10/14.
BACKGROUND: ebA Multivitamin Supplement was distributed nationwide and in Australia, Canada, Costa Rica, England, Finland, Ireland, Malaysia, Switzerland, and Tasmania. and reached consumers by mail order, fax order, internet sales and doctors' office sales. The vitamins are packaged in a white plastic bottle with white, green and blue labeling. The expiration date is listed beneath the Warning section on the label.

22 abril, 2013

Preeclampsia as a Risk Factor for Diabetes: A Population-Based Cohort Study

Belly of a woman in her 34th week of pregnancy.
Belly of a woman in her 34th week of pregnancy. (Photo credit: Wikipedia)
See original in PLoS

Background

Women with preeclampsia (PEC) and gestational hypertension (GH) exhibit insulin resistance during pregnancy, independent of obesity and glucose intolerance. Our aim was to determine whether women with PEC or GH during pregnancy have an increased risk of developing diabetes after pregnancy, and whether the presence of PEC/GH in addition to gestational diabetes (GDM) increases the risk of future (postpartum) diabetes.

Methods and Findings

We performed a population-based, retrospective cohort study for 1,010,068 pregnant women who delivered in Ontario, Canada between April 1994 and March 2008. Women were categorized as having PEC alone (n = 22,933), GH alone (n = 27,605), GDM alone (n = 30,852), GDM+PEC (n = 1,476), GDM+GH (n = 2,100), or none of these conditions (n = 925,102). Our main outcome was a new diagnosis of diabetes postpartum in the following years, up until March 2011, based on new records in the Ontario Diabetes Database. The incidence rate of diabetes per 1,000 person-years was 6.47 for women with PEC and 5.26 for GH compared with 2.81 in women with neither of these conditions. In the multivariable analysis, both PEC alone (hazard ratio [HR] = 2.08; 95% CI 1.97–2.19) and GH alone (HR = 1.95; 95% CI 1.83–2.07) were risk factors for subsequent diabetes. Women with GDM alone were at elevated risk of developing diabetes postpartum (HR = 12.77; 95% CI 12.44–13.10); however, the co–presence of PEC or GH in addition to GDM further elevated this risk (HR = 15.75; 95% CI 14.52–17.07, and HR = 18.49; 95% CI 17.12–19.96, respectively). Data on obesity were not available.

Conclusions

Women with PEC/GH have a 2-fold increased risk of developing diabetes when followed up to 16.5 years after pregnancy, even in the absence of GDM. The presence of PEC/GH in the setting of GDM also raised the risk of diabetes significantly beyond that seen with GDM alone. A history of PEC/GH during pregnancy should alert clinicians to the need for preventative counseling and more vigilant screening for diabetes.