Drug Safety ציבורי
[search 0]
עוד
Download the App!
show episodes
 
Artwork

1
Drug Safety Matters

Uppsala Monitoring Centre

Unsubscribe
Unsubscribe
חודשי
 
Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring.
  continue reading
 
Artwork

1
FDA Drug Safety Podcasts

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

Unsubscribe
Unsubscribe
חודשי
 
FDA Drug Safety Podcasts, produced by FDA's Center for Drug Evaluation and Research, provide emerging safety information about drugs in conjunction with the release of Drug Safety Communications. For more information, please visit: www.fda.gov/drugsafetypodcasts
  continue reading
 
Loading …
show series
 
Serious and unexpected adverse drug reactions – the ‘black swans’ of pharmacovigilance – can place enormous strain on safety monitoring systems. Drawing examples from the COVID-19 pandemic, François Montastruc from Toulouse University Hospital explains how we can get better at dealing with the unpredictable. Tune in to find out: What Nassim Nichola…
  continue reading
 
Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab).
  continue reading
 
The liver is the primary site for drug metabolism in the body, but it can be severely damaged by medicines or their toxic compounds. Rita Baião from the North Lisbon University Hospital Center reviews what pharmacovigilance professionals should know about drug-induced liver injury (DILI). Tune in to find out: Who is most at risk of developing DILI …
  continue reading
 
What did the drug safety community achieve in 2023 and how will the field develop in 2024? As the year comes to a close, we asked Angela Caro, president of the International Society of Pharmacovigilance (ISoP), to walk us through current and future trends in pharmacovigilance. Tune in to find out: Why patient engagement is a growing priority What c…
  continue reading
 
Listen to an audio podcast of the November 28, 2023, FDA Drug Safety Communication, FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).
  continue reading
 
To mark #MedSafetyWeek, which took place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this second part, we hear from three #MedSafetyWeek veterans – Anne-Cécile Vuillemin from the Ministry of Health in Luxembourg, Ban Al-Shimran from the Iraqi Ministry of Health, and Frieda Shigwedh…
  continue reading
 
To mark #MedSafetyWeek, which takes place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this first part, we speak to Mitul Jadeja from the Medicines and Healthcare products Regulatory Agency in the UK about under-reporting and how initiatives like #MedSafetyWeek can help draw attenti…
  continue reading
 
Herbal remedies have been used for thousands of years to treat what ails us. Yet why do we still know so little about their potential side effects compared to modern medicines? This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the ori…
  continue reading
 
A patient's perspective can ensure safe medical care and lead to new insights that traditional research may overlook. But how do we best harness that perspective to improve patient outcomes? This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format…
  continue reading
 
Medicines safety monitoring is a continuous process that begins with pre-marketing clinical trials and continues with post-marketing studies to fill any gaps in knowledge. With Marianne Lunzer from AGES and Sanja Prpić from HALMED, we review the pros and cons of various study types and the importance of testing medicines on diverse populations. Tun…
  continue reading
 
Healthcare professionals are key players in medicines safety but they often lack the time or knowledge to report adverse drug reactions. To change that, we need to urgently rethink how we teach pharmacovigilance, argues Michael Reumerman from Amsterdam University Medical Centers. Tune in to find out: How real-life education can benefit healthcare s…
  continue reading
 
The vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson & Johnson discusses how to harness real-world data for patient safety. Tune in to find out: How …
  continue reading
 
Spontaneous reports of adverse drug reactions are a common source of evidence in pharmacovigilance, but as the science evolves, so do the types of data used to find and assess signals. Uppsala Monitoring Centre’s Daniele Sartori reviews how signal detection practices have changed over time. Tune in to find out: Which features of case reports are mo…
  continue reading
 
Most pharmacovigilance professionals will have heard of masking – a statistical issue where reports for one drug hide signals for other drugs. But the problem gained fresh attention when record amounts of reports began piling up for the COVID-19 vaccines. How should we be unmasking data in the COVID-19 vaccine era? This episode is part of the Uppsa…
  continue reading
 
The COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety. Tune in to find out: How t…
  continue reading
 
The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges…
  continue reading
 
Public trust in vaccines hinges on their safety – but to make sure vaccines are safe, we must have systems in place to detect and manage any side effects. Dr Madhava Ram Balakrishnan, medical officer for vaccine safety at the World Health Organization, discusses how to build an effective vaccine surveillance system and how to respond to safety cris…
  continue reading
 
Listen to an audio podcast of the 6/1/22 for Ukoniq . FDA withdrew its approval for the cancer medicine Ukoniq (active ingredient umbralisib) due to safety concerns. Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL)
  continue reading
 
Managing antimicrobial resistance (AMR) will require innovative solutions from many different disciplines. Could pharmacovigilance be one of them? Jean Marie Vianney Habarugira and Albert Figueras, who have been investigating how drug safety tools could help track AMR, think it’s time the two communities joined forces for good. Tune in to find out:…
  continue reading
 
With the right care, people infected with HIV can lead long and healthy lives. But as with any life-long medical treatment, it is important to acknowledge and manage any side effects. Henry Zakumumpa from Makerere University School of Public Health tells us about the potential harms of new HIV therapies and the challenges faced by pharmacovigilance…
  continue reading
 
Access to medical products has increased considerably in Africa in recent years, but safety monitoring systems haven’t exactly kept pace and many African countries still struggle to address safety issues. We sat down with Eleni Aklillu and Abbie Barry of the PROFORMA project to learn about their efforts to strengthen pharmacovigilance capacity in E…
  continue reading
 
People’s perception of risk can vary greatly from person to person, making it challenging for healthcare professionals to communicate benefits and harms of medicines in a balanced fashion. Alexandra Freeman from the Winton Centre for Risk and Evidence Communication discusses how to give patients the information they need to decide what's best for t…
  continue reading
 
Listen to an audio podcast of the February 3, 2022, FDA Drug Safety Communication, FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib). We are re-evaluating this risk against the benefits of Ukoniq for its approved uses.
  continue reading
 
The loss of vital health records is a universal problem for refugees. When their medical information goes missing, patients are less likely to receive the care they need and more likely to be prescribed the wrong treatments. Thankfully, the International Society of Pharmacovigilance Egypt Chapter and the Palestine Red Crescent Society are taking on…
  continue reading
 
Listen to an audio podcast of the January 12, 2022, FDA Drug Safety Communication warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.
  continue reading
 
Statistical tools can not only cut through the noise in large pharmacovigilance databases. They can also help identify more clinically meaningful patterns in the data. Uppsala Monitoring Centre’s Jim Barrett and Joe Mitchell explain how vigiGroup, a novel clustering algorithm, can bring value to signal detection. Tune in to find out: What the limit…
  continue reading
 
With vaccine hesitancy on the rise and misinformation spreading like wildfire on social media, drug safety specialists may have a hard time knowing how to talk about side effects without affecting people’s trust in vaccinations. Anthony Cox from the University of Birmingham and Daniel Salmon from the Institute for Vaccine Safety share their best ad…
  continue reading
 
It’s not always easy to choose the best medicine for a child. Some drugs are inappropriate for young patients, while others require special consideration or monitoring. For years, clinicians had only historical dogmas, word of mouth and their own experience to guide their choices. But a valuable new resource promises to change paediatric prescribin…
  continue reading
 
Listen to an audio podcast of the September 1, 2021 FDA Drug Safety Communication on requiring revisions to the Boxed Warning for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
  continue reading
 
Fuelled by disinformation and an array of other cultural and economic factors, vaccine hesitancy is one of the greatest global health communication challenges of our times. But to craft the empathetic and tailored communication strategies required to boost confidence in vaccines, we first need to understand the difference between anti-vaccination b…
  continue reading
 
Genetic variation is one of the reasons people differ in their response to medicines. Understanding that variation can inform more refined choices of drugs and doses – ultimately preventing undesired side effects. Join us as we discuss past, present and future of pharmacogenomics with Uppsala Monitoring Centre’s Qun-Ying Yue. Tune in to find out: H…
  continue reading
 
Listen to an audio podcast of the July 20, 2021 FDA Drug Safety Communication, FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
  continue reading
 
With COVID-19 vaccinations rolling at full speed in many countries, there’s a lot of talk about vaccine safety monitoring. But what exactly does that mean and how should we be interpreting data on side effects? Uppsala Monitoring Centre’s Helena Sköld and Annette Rudolph walk us through the basics of vaccine pharmacovigilance. Tune in to find out: …
  continue reading
 
Listen to FDA Drug Safety Podcast on due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis
  continue reading
 
While COVID-19 vaccinations are picking up speed in many wealthy countries, citizens of lower-income countries still face a long wait ­– and where demand exceeds supply, black markets tend to form. So to curb the spread of substandard and falsified products, says drug regulatory specialist Danini Marin, we must ensure that COVID-19 vaccines are dis…
  continue reading
 
Antimicrobial resistance (AMR) is not only a biological issue, but a complex social problem. As a consequence, changing the way patients, healthcare professionals and policymakers think about antibiotics will require input from both the natural and social sciences. In March 2021, the Uppsala Health Summit on “Managing antimicrobial resistance throu…
  continue reading
 
Listen to an audio podcast of the March 31, 2021 FDA Drug Safety Communication that FDA review of studies show a potential increased risk of heart rhythm problems, in patients with heart disease taking lamotrigine (Lamictal). FDA requiring studies to evaluate heart risk across the drug class.
  continue reading
 
Listen to an audio podcast of the March 25, 2021 FDA Drug Safety Communication warning that abuse and misuse of the over the counter (OTC) nasal decongestant propylhexedrine (brand name Benzedrex) can lead to serious harm such as heart and mental health problems.
  continue reading
 
As the COVID-19 pandemic spread around the world, so did waves of viral misinformation. For pharmacovigilance manager Marco Tuccori, fighting the “infodemic” is a massive, but necessary, battle. This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio for…
  continue reading
 
By definition, a rare disease is one that only affects a handful of people in the world. But with more than 300 million people collectively affected by these conditions and only few approved treatments available, rare diseases constitute a major unmet medical need. Christina Ström Möller from Swedish biopharmaceutical company Sobi walks us through …
  continue reading
 
Listen to FDA Drug Safety Podcast on Drug Safety Communication titled "Initial safety trial results find increased risk of serious heart-related problems and cancer with tofacitinib (Xeljanz, Xeljanz XR)
  continue reading
 
As the cradle of modern humanity, the African continent is home to populations with high levels of genetic diversity. But while this diversity has implications for the safety and efficacy of many drugs, African patients remain underrepresented in drug studies. In fact, while more than 400 medicines have pharmacogenetics information and public guide…
  continue reading
 
In the age of evidence-based medicine, we may be tempted to dismiss intuition – the quick and automatic thought process we call “sixth sense” or “gut feeling” – as unscientific guesswork. But in clinical decision-making, intuitive reasoning is just as important as the slower and more analytical causal reasoning that healthcare professionals are tra…
  continue reading
 
Loading …

מדריך עזר מהיר