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Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall – Due to a Lack of Adequate Controls

Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608254.htm

 
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FDA MedWatch – Keytruda (pembrolizumab) or Tecentriq (atezolizumab): Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy

MedWatch – The FDA Safety Information and Adverse Event Reporting Program
A new MedWatch Safety Alert: Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement – Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy  intended for: Oncology, Pharmacy, Risk Manager was just added to the FDA MedWatch Webpage.

You can read the complete MedWatch Safety Alert that includes recommendations at: https://go.usa.gov/xQPtf

 
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FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings

05-16-2018 UpdateIn addition to approving the updated prescribing information concerning the gadolinium retention safety issues described in the Drug Safety Communication below, FDA has also approved new patient Medication Guides for all GBCAs.

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.

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For more information go to https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm 

 
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Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate – Potential Risk of Neural Tube Birth Defects

Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.

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.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608168.htm

 
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Talleres de buenas prácticas en la gestión integral de los residuos electrónicos

Preparándonos para el apagón analógico

Talleres de buenas prácticas en la gestión integral de los residuos electrónicos

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El llamado “apagón analógico” que se llevará a cabo el 14 de agosto de 2019, dará paso a la Televisión Digital en Costa Rica… 

https://www.ministeriodesalud.go.cr/index.php/noticias/noticias-2018/1303-talleres-de-buenas-practicas-en-la-gestion-integral-de-los-residuos-electronicos