All articles tagged with #adverse events
The FDA warns that some Abbott FreeStyle Libre 3 and 3 Plus glucose sensors may provide incorrect low readings due to a manufacturing issue, linked to hundreds of adverse events and seven deaths outside the U.S. Patients are advised to stop using affected devices and seek replacements, as the issue has been identified and resolved.
Following the death of a second patient treated with Elevidys for Duchenne muscular dystrophy, families and advocates are calling for greater transparency, improved safety data collection, and stronger regulatory oversight to ensure patient safety and informed decision-making in the use of this high-cost gene therapy.
Verastem (VSTM) stock plummeted by 62% following the release of clinical trial data for its metastatic pancreatic cancer treatment, which revealed serious adverse events in 12 patients, including 11 with grade ≥3 events. Despite initial positive results, the safety concerns led to heavy trading and a significant drop in stock value.
A University of Michigan study has found that adverse childhood experiences can impact muscle function in older adults by impairing mitochondrial activity, leading to reduced ATP production. The research, which analyzed muscle biopsies from over 870 participants aged 70 and older, highlights the long-term health consequences of childhood trauma on physical health and emphasizes the importance of addressing childhood traumas to mitigate their lasting effects on aging outcomes.
The largest global vaccine safety study to date found small increases in neurological, blood, and heart-related conditions linked to Covid-19 vaccines, including heart-related inflammation from mRNA shots and an increased risk of blood clots and neurological disorders from viral-vector vaccines. While over 13.5 billion doses of Covid vaccines have been administered globally, saving over 1 million lives in Europe alone, a small proportion of people immunized were injured by the shots, sparking debate about their benefits versus harms. Additionally, a separate study conducted by the Yale School of Medicine identified common symptoms in adults experiencing chronic post-vaccination syndrome, which aims to understand the condition and improve vaccine safety.
The FDA is warning consumers against purchasing or using tianeptine products due to severe risks, including death, and lawmakers are calling for immediate action. Tianeptine, an antidepressant prescribed in other countries, is not approved for use in the US and is often sold illegally as a dietary supplement, posing serious health risks such as agitation, drowsiness, and even death. Lawmakers have urged the FDA to take action, and a company has voluntarily recalled its tianeptine products. The substance has been linked to numerous adverse events and deaths, and its availability in gas stations and convenience stores poses a significant risk, especially amid the ongoing opioid epidemic.
Reports of possible mental health side effects, including anxiety, depression, and suicidal thoughts, have been increasing among individuals taking Ozempic, an injectable drug approved for Type 2 diabetes. While the drug has gained popularity for its potential weight loss benefits, these mental health concerns are not mentioned in its instructions for use. European regulators are investigating the risk of self-harm and suicidal thoughts associated with Ozempic and similar drugs, while the FDA is monitoring the situation. The FDA's adverse event reporting system has received 489 reports of patients experiencing mental health issues while taking semaglutide drugs, including Ozempic. However, the database cannot determine whether these events are directly caused by the drug or other factors. Patients are advised to consult with their doctors if they experience any unusual symptoms.
A study conducted by researchers at Brown University compared the Moderna and Pfizer-BioNTech COVID-19 vaccines in over six million older adults and found that the Moderna vaccine was associated with slightly lower risks of certain adverse events, such as pulmonary embolism and thromboembolic events. The study highlights the importance of understanding real-world vaccine performance and recommends further research, including the evaluation of subsequent vaccinations and newly developed vaccines. While both vaccines were found to have low risks of adverse events, the findings suggest that the Moderna vaccine may have a slight edge over Pfizer-BioNTech for older adults.
Researchers at Yale University are expanding their ongoing LISTEN study to include individuals experiencing adverse events after COVID-19 vaccination, in an effort to understand the rare symptoms that can occur post-vaccination. These symptoms, sometimes referred to as "long vax," resemble those seen in long COVID, including small-fiber neuropathy and postural orthostatic tachycardia syndrome (POTS). The study aims to match abnormal post-vaccine symptoms with corresponding immune responses and develop a better understanding of the mechanisms and potential therapeutic strategies for these conditions. The researchers also hope to provide support and validation to those experiencing post-vaccination symptoms and move the discussion away from politics and into science.
Modest reductions in kidney function, even within the normal range, are associated with a higher risk of adverse events, particularly among younger adults. A large cohort study found that slight decreases in estimated glomerular filtration rate (eGFR) were linked to a 42% increased risk of all-cause mortality, cardiovascular events, and kidney failure in adults under 40 years old. The findings highlight the importance of monitoring kidney function and adopting a healthy lifestyle to prevent future kidney and heart diseases. Once chronic kidney disease develops, it is rarely reversible, making early detection and prevention crucial.
The article discusses the prevalence of the rotavirus vaccine despite its adverse events, including death. It explores why infants need to get vaccinated against rotavirus, which can cause severe diarrhea and dehydration. Parents are advised to consider the risks and benefits of the vaccine when deciding whether to give it to their child.
The FDA has required updates to improve the safe use of prescription stimulants due to the increasing number of adverse events associated with their nonmedical use. Nonmedical use of prescription stimulants has remained stable over the past two decades, with the most common source being from family and friends. People who use prescription stimulants nonmedically may have a higher risk of developing a substance use disorder than those who do not. Deaths involving stimulants continue to increase and often involve multiple substances, such as opioids. People seeking to illegally obtain prescription stimulants from others have been exposed to greater risks due to the increasing presence of illicit sellers offering falsified prescription stimulant products that contain harmful substances such as methamphetamine or fentanyl.