Categories

FDA: Fecal Microbiota for Transplantation: Safety Alert – Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19

FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT)

http://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-safety-alert-regarding-additional-safety-protections-pertaining

 
Categories

WHO: There is a lot of false information around… These are the facts!

These are the facts:

🔢 People of all ages CAN be infected by the coronavirus. Older people, and people with pre-existing medical conditions (such as asthma, diabetes, heart disease) appear to be more vulnerable to becoming severely ill with the virus.

❄️ Cold weather and snow CANNOT kill the coronavirus.

☀️ The coronavirus CAN be transmitted in areas with hot and humid climates

🦟 The coronavirus CANNOT be transmitted through mosquito bites.

🐶 There is NO evidence that companion animals/pets such as dogs or cats can transmit the coronavirus.

🛀 Taking a hot bath DOES NOT prevent the coronavirus

💨 Hand dryers are NOT effective in killing the coronavirus

🟣 Ultraviolet light SHOULD NOT be used for sterilization and can cause skin irritation

🌡️ Thermal scanners CAN detect if people have a fever but CANNOT detect whether or not someone has the coronavirus

💦 Spraying alcohol or chlorine all over your body WILL NOT kill viruses that have already entered your body

💉 Vaccines against pneumonia, such as pneumococcal vaccine and _Haemophilus influenzae_ type b (Hib) vaccine, DO NOT provide protection against the coronavirus.

👃 There is NO evidence that regularly rinsing the nose with saline has protected people from infection with the coronavirus.

🧄 Garlic is healthy but there is NO evidence from the current outbreak that eating garlic has protected people from the coronavirus.

💊 Antibiotics DO NOT work against viruses, antibiotics only work against bacteria.

🧪 To date, there is specific medicine recommended to prevent or treat the coronavirus.

 

Check the facts on the WHO website: click here

 

 

 
Categories

PAHO: Clinical trials of drug repositioning for COVID-19 treatment

Rosa and Santos

The World Health Organization (WHO) was informed in December 2019 about a coronavirus pneumonia outbreak in Wuhan, Hubei province (China). Subsequently, on March 12, 2020, 125,048 cases and 4,614 deaths were reported. Coronavirus is an enveloped RNA virus, from the genus Betacoronavirus, that is distributed in birds, humans, and other mammals. WHO has named the novel coronavirus disease as COVID-19. More than 80 clinical trials have been launched to test coronavirus treatment, including some drug repurposing or repositioning for COVID-19. Hence, we performed a search in March 2020 of the clinicaltrials.gov database. The eligibility criteria for the retrieved studies were: contain a clinicaltrials.gov base identifier number; describe the number of participants and the period for the study; describe the participants’ clinical conditions; and utilize interventions with medicines already studied or approved for any other disease in patients infected with the novel coronavirus SARS-CoV-2 (2019-nCoV). It is essential to emphasize that this article only captured trials listed in the clinicaltrials.gov database. We identified 24 clinical trials, involving more than 20 medicines, such as human immunoglobulin, interferons, chloroquine, hydroxychloroquine, arbidol, remdesivir, favipiravir, lopinavir, ritonavir, oseltamivir, methylprednisolone, bevacizumab, and traditional Chinese medicines (TCM). Although drug repurposing has some limitations, repositioning clinical trials may represent an attractive strategy because they facilitate the discovery of new classes of medicines; they have lower costs and take less time to reach the market; and there are existing pharmaceutical supply chains for formulation and distribution.

Article’s language
English
 
Categories

Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

For Immediate Release:
Statement From:
Commissioner of Food and Drugs – Food and Drug Administration

Stephen M. Hahn M.D.

Associate Commissioner for Regulatory Affairs – Office of Regulatory Affairs

Judith A. McMeekin Pharm.D.

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

For more information go to

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits

 
Categories

Current information on FDA actions in response to COVID-19

On diagnostics for COVID-19

  • FDA has issued an Immediately In Effect Guidance for laboratories and commercial manufacturers to help accelerate the use of test they develop in order to achieve more rapid and widespread testing capacity.  The guidance also provides FDA’s recommendations regarding validation of COVID-19 tests (see section V of the guidance).  The guidance can be found at the following link:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help

Other actions

 

 

  • FDA also announced that they would be taking steps to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. This action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s

 

FDA maintains a webpage dedicated to announcements and information related to COVID, which is updated daily.  It can be found at the following link:  https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19

 
Categories

PAHO: Announcement about Ibuprofen and COVID-19

Announcement about Ibuprofen and COVID-19 (Washington, DC. 18 March, 2020)

18 Mar 2020

Regarding information that appeared in the media about the risk of using ibuprofen in COVID-19 infections, between March 15 and March 18, 2020 the World Health Organization (WHO) and some regulatory authorities such as the European Medicines Agency (EMA), National Health Services (NHS) in the United Kingdom, Spanish Agency of Medicines and Medical Devices (AEMPS) in Spain, and the Health Products Regulatory (HPRA) in Ireland have stated that there is currently no evidence to support an aggravation of COVID-19 infection with ibuprofen or other NSAIDs.

In short and pending new data, we believe the approach suggested by the UK NHS is appropriate. It addresses the lack of evidence regarding harmful effects of ibuprofen on covid-19 infections and does not advise to discontinue ongoing treatments with this medicine but, if treatment is initiated, prioritizes the use of paracetamol to treat symptoms of the infection.

Download the document 

 
Categories

European Medicine Agency (EMA) gives advice on the use of non-steroidal anti-inflammatories for COVID-19

European Medicine Agency (EMA) is aware of reports, especially on social media, which raise questions about whether non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen could worsen coronavirus disease (COVID-19).

There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic.

For more information go to https://www.ema.europa.eu/en/news/ema-gives-advice-use-non-steroidal-anti-inflammatories-covid-19

 
Categories

World Health Organization (WHO) and COVID-19

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).

Coronavirus disease (COVID-19) is a new strain that was discovered in 2019 and has not been previously identified in humans.

Visit https://www.who.int/health-topics/coronavirus