http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4442240
http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4442085
You can read the complete MedWatch Safety Alert that includes recommendations at: https://go.usa.gov/xQPtf
Source: World health statistics 2018: monitoring health for the SDGs, sustainable development goals. Geneva: World Health Organization; 2018. CC BY-NC-SA 3.0 IGO.
ISBN: 978-92-4-156558-5
Published online: May 2018
The World Health Statistics series is WHO’s annual snapshot of the state of the world’s health. This 2018 edition contains the latest available data for 36 health-related Sustainable Development Goal (SDG) indicators. It also links to the three SDG-aligned strategic priorities of the WHO’s 13th General Programme of Work: achieving universal health coverage, addressing health emergencies and promoting healthier populations.
The latest data show that:
:: Less than half the people in the world today get all of the essential health services they need.
:: In 2010, almost 100 million people were pushed into extreme poverty because they had to pay for health services out of their own pockets.
:: 13 million people die every year before the age of 70 from cardiovascular disease, chronic respiratory disease, diabetes and cancer – most in low and middle-income countries.
:: Every day in 2016, 15 000 children died before reaching their fifth birthday.
:: 303 000 women died due to complications of pregnancy or childbirth in 2015. Almost all of these deaths occurred in low- and middle-income countries (99%). Reducing maternal mortality crucially depends upon ensuring that women have access to quality care before, during and after childbirth.
For details and additional information / Más información y material adicional click here.
Full report / Informe completo click here.
La Agencia Nacional de Vigilancia Sanitaria del Brasil (Anvisa) certificó por primera vez en Buenas Prácticas de Manufactura (BPM) a dos laboratorios colombianos fabricantes de medicamentos sin necesidad de visita, es decir basándose únicamente en las actas de inspección del Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima).
Los laboratorios que lograron certificarse son: Procaps S.A. (Barranquilla) y Eurofarma Colombia S.A.S. (Bogotá).
Esta importante conquista se logra gracias al reconocimiento de Invima como Autoridad Reguladora Nacional de Referencia Regional ARNr de nivel IV ante la Organización Panamericana de la Salud (OPS) que indica que la agencia cuenta con metodologías uniformes y transparentes para el cumplimiento de sus funciones de control y fiscalización, garantizando la eficacia, seguridad y calidad de los medicamentos. De igual forma, ANVISA também es reconhecida como una de das ocho ARNr.
Health care professionals and patients can access the patient Medication Guides according to the GBCA drug name* on the Medication Guides webpage, or the latest prescribing information by searching in Drugs@FDA.
All MRI centers should provide a Medication Guide the first time an outpatient receives a GBCA injection or when the information is substantially changed. In general, hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it. A health care professional who determines that it is not in a patient’s best interest to receive a Medication Guide because of significant concerns about its effects may direct that it not be provided to that patient; however, the Medication Guide should be provided to any patient who requests the information.†
*The brand names of the GBCAs can be found in Table 1 below.
†For more information on distribution of Medication Guides, see the Guidance Document, the Drug Info Rounds Video, or the Code of Federal Regulations at 21 CFR 208.26.
(…)
For more information go to https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm
Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66830a-eng.php
http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4430169
Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly. To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. We are investigating this new safety issue and will update the public when we have more information.
