Articles tagged with Drug Safety
Scientists have developed a new material to restore lost flexibility in human vocal cords, which can help alleviate voice loss due to aging, disease, or medical procedures. The material, called polyethylene glycol 30 (PEG30), is flexible and can vibrate like human vocal cords.
The Wyss Institute is developing an automated instrument that integrates 10 human organs-on-chips to study complex human physiology outside the body. This will accelerate assessment of drug safety and efficacy, informing regulatory decision-making.
The NIH is funding the creation of tissue chips with living cells and tissues to model human organs and predict drug safety. These chips will be tested with compounds known to be safe or toxic, ultimately advancing research to help identify reliable drug safety signals.
A study found that rituximab, an immune drug, helped patients with serious kidney disorder idiopathic membranous nephropathy experience remission, even when standard therapies failed. The treatment was safe and well-tolerated, with all patients achieving complete or partial remission over time.
The NIH is launching a clinical trial to test the safety and tolerability of maraviroc-based pre-exposure prophylaxis (PrEP) regimens for HIV prevention. The study aims to reduce the risk of infection by enrolling 400 HIV-uninfected men who have sex with men in 12 cities across the US and Puerto Rico.
A new study examines real-life usage of Xigris over ten years and concludes that its efficacy is comparable to the original PROWESS trial. The study found a significant reduction in hospital death risk for patients with severe sepsis.
A study by Kansas State University researchers found that prescription drug warning labels often fail to attract attention, impairing the communication of critical safety information. The research highlights the need for an effective labeling standard to improve patient safety and reduce medication errors, particularly among older adults.
A new study from the University of Manchester confirms safety indicators for people taking anticoagulant drugs to regulate atrial fibrillation, a condition that increases stroke risk. The study found that patients with high INR levels were more likely to experience bleeding episodes.
A large analysis found that three widely used diabetes medications - glipizide, glyburide, and glimepiride - are associated with a greater risk of death compared to metformin. These sulfonylureas were linked to a 50% increased risk of mortality, while glimepiride appeared to be safer in patients with heart disease.
Research reveals that secretly unfaithful individuals are less likely to practice safe sex and more likely to engage in high-risk behaviors. Monogamy can be an effective method for preventing STIs, but its effectiveness relies on couples' commitment to testing negative at the start of their relationship.
A new computer model has successfully predicted negative side effects in hundreds of current drugs by analyzing their chemical structures and known side-effect molecules. The model identified potential side effects for 151 previously unknown compounds, including a synthetic form of estrogen that causes stomach pain.
A recent study published in the Journal of General Internal Medicine found that nearly a quarter of adults at risk of overdosing on single OTC acetaminophen products by exceeding the dose of four grams in a 24-hour period. Additionally, nearly half were at risk of overdosing by 'double-dipping' with two acetaminophen-containing products.
La Jolla Institute scientists discovered a mechanism key in drug allergy, identifying HLA gene-linked hypersensitivity reactions before use in humans. The finding could lead to pre-screening of drugs at risk of causing severe reactions.
A team of researchers from UCSF and UC San Diego has identified an approved arthritis drug, auranofin, that is effective against amoebas in lab and animal studies, suggesting it could offer a low-dose, low-cost treatment for dysentery worldwide. The drug has been shown to be 10 times more potent than the current treatment and could be ...
A new study by Yale School of Medicine researchers found that the US FDA generally approves drug therapies faster and earlier than its counterparts in Canada and Europe. On average, it took 322 days for the FDA to review a drug application, compared to 366 days for the European Medicines Agency and 393 days for Health Canada.
The IOM report recommends the FDA implement a single, comprehensive Benefit and Risk Assessment and Management Plan (BRAMP) to track drugs' side effects. Postmarket studies will be conducted when necessary to inform regulatory decisions, with an emphasis on protecting research participants.
A Johns Hopkins-led study found that etanercept, a genetically engineered small-protein drug, does not provide better relief for sciatica back pain compared to steroid injections. In the study, patients who received epidural steroid injections reported more significant pain relief and improved overall symptoms after one month.
A recent study found that nursing home RNs and LPNs differ in their approach to medication reconciliation, leading to opportunities for improved collaboration. Enhancing training and assigning complementary roles may improve patient care and satisfaction.
A study examining clot-busting drugs in children with ischemic stroke found that these medications can be safely administered, with a higher risk of bleeding but similar mortality rates compared to adults. Researchers believe further studies are needed to optimize treatment effectiveness in pediatric patients.
The study validated the use of a microchip-based device to deliver teriparatide for osteoporosis treatment, with results comparable to standard injections. The implant showed biocompatibility and was well-tolerated by patients, providing proof-of-concept for long-term device viability.
A new study reveals benfluorex, a fenfluramine derivative used in France from 1976 to 2009, was responsible for approximately 3,100 hospitalizations and 1,300 deaths. The use of this drug led to significant changes in the French regulatory system.
The BWH Center for LAM Research and Clinical Care has been awarded a four-year grant to conduct a phase I clinical trial testing the safety and efficacy of a combination of hydroxychloroquine and sirolimus in treating LAM. This is the first time this drug combination has been tested in women with LAM.
The American College of Physicians (ACP) endorses the use of metformin as the initial treatment for most patients with type 2 diabetes, especially when lifestyle modifications have failed. The guideline also advises adding a second drug to metformin when necessary.
The American College of Physicians recommends metformin as the initial drug treatment for most patients with type 2 diabetes who have failed lifestyle modifications. Additionally, a study found that women are more likely to experience complications after implantable cardioverter-defibrillator (ICD) placement compared to men. Meanwhile,...
Researchers compared clot busting treatments in patients with wake-up stroke and those treated within 4.5 hours of symptom onset, finding similar death rates, risk of bleeding, and recovery rates. The study suggests administering clot-busting drugs to wake-up stroke patients is feasible and safe.
A new system for delivering cyclosporine has been developed by scientists at the University of Strathclyde, enabling safe and effective treatment with minimal harm to kidneys. The system uses nanoparticles to deliver the drug orally, maintaining a strong dose while sparing organs from damage.
Researchers at Boston Children's Hospital developed a new mathematical model to predict drug-ADE relationships, identifying issues up to 5 years before they occur. The approach has shown promising results, correctly predicting 42% of absent drug-ADE relationships and accurately recognizing false pairs.
A large study group of Kentucky women found that only 30% were receiving warfarin for atrial fibrillation. The study suggests warfarin anticoagulation treatment is underutilized in this population, but not due to economic or educational disparities.
A recent study has found that PROMETAT, a popular but controversial treatment for methamphetamine addiction, is no more effective than placebo in reducing methamphetamine use. The study, funded by the company behind the treatment, Hythiam, suggests that the program may not be an effective solution for those struggling with addiction.
A study found that drospirenone-containing oral birth control pills are associated with a significantly increased risk of venous thrombotic events, including deep vein thrombosis and pulmonary embolism. Risk was highest in the early months of use and was also influenced by factors such as age, high blood pressure, and obesity.
A study found that varenicline (Chantix) is associated with a substantially increased risk of reported depression or suicidal behavior compared to other smoking-cessation treatments. The researchers identified 90% of all reported suicides related to smoking cessation drugs since 1998 implicated varenicline.
A new treatment for severe hemophilia A patients with inhibitors has been shown to be highly effective in preventing bleeding events. The study, published in the New England Journal of Medicine, found that FEIBA infused three times a week resulted in a 62% reduction in all bleeding events and a 72% reduction in target joint bleeding.
The Common Drug Review introduced in 2003 standardized the process for public drug plans, covering 39% of Canada's $31 billion in forecasted drug costs. The review led to a significant decrease in drug listings, with smaller provinces experiencing earlier access to new drugs.
A pilot study found that nearly 30% of US homes with young children store acetaminophen products unsafely, with most homes containing expired medications. The study suggests that proper storage is crucial to prevent unintentional poisonings, particularly in homes with young children.
A new analysis of non-steroidal anti-inflammatory drugs (NSAIDs) found that naproxen and low-dose ibuprofen have a lower risk of cardiovascular events. In contrast, diclofenac increases the risk, even at non-prescription doses.
Substitution of brand name immunosuppressive drug with a generic drug appears to be safe for transplant recipients. The study reveals that this change can lead to significant cost savings through long-term use of the generic product.
A US study found that many Americans believe only highly effective drugs without serious side effects are approved. Brief explanations to patients about drug benefits and harms uncertainties can help them make better choices. The FDA does not guarantee a large or important benefit from a drug or that all serious adverse effects are known.
A University of Leeds investigation found that many over-the-counter herbal remedies are missing crucial safety information, despite new EU regulations. The study evaluated 68 products from various stores and pharmacies, revealing 93% were unlicensed and lacking comprehensive warnings.
Research reveals that over-the-counter herbal products often fail to provide essential safety information, putting users at risk of adverse effects and interactions with other drugs. The study found that nearly all products were unlicensed and marketed as food supplements, highlighting the need for reliable information and regulation.
Researchers advocate for expanded EHR use to address medical errors and improve care quality. Implementing Joint Commission's 2011 National Patient Safety Goals into EHR criteria can help fast-track the use of EHRs for patient safety.
A Pew Charitable Trusts study reveals serious gaps in US drug safety oversight, with 40% of finished drugs sourced from overseas. The report identifies links in the supply chain that need strengthening to ensure safe medicines.
Michigan State University researchers are reformulating a decades-old drug to combat two debilitating tropical diseases. The goal is to develop a safe and effective treatment for filarial diseases, which affect millions worldwide. With clinical trials expected to begin in about two years, the team hopes to bring hope to those affected ...
A new study found that varenicline, marketed as Chantix, significantly increases the risk of hospitalization due to serious cardiovascular problems, including heart attacks and arrhythmias. The study, published in CMAJ, suggests that clinicians should carefully weigh the benefits against the risks.
A national survey found that 1 in 20 Australian workers use alcohol or drugs while on the job. The most commonly used workplace drug was alcohol, followed by painkillers and amphetamines. Despite this, many workers underestimate the negative impact of substance use on workplace safety.
A new study found that US Medicaid's Preferred Drug Lists vary widely from state to state, ignoring international guidelines for safe and effective medications. The WHO Essential Medicines List is not used as a basis for state lists, resulting in patients receiving more expensive and less effective treatments.
A new study suggests that people using mist inhalers to deliver the commonly prescribed COPD medication tiotropium may be 52% more likely to die. The findings raise concerns not only about the device but also about the drug itself, particularly its potential link to cardiovascular disease.
Researchers found that alemtuzumab is as safe and effective as basiliximab or antithymocyte globulin in preventing organ rejection after kidney transplant. The study's results suggest that the less expensive drug option could lead to cost savings without compromising patient outcomes.
A large Danish study found no significant association between prenatal use of newer-generation antiepileptic drugs and major birth defects. The study included data on over 837,000 infants and compared their birth defect rates with those exposed to older-generation antiepileptic drugs.
A new UTHealth trial aims to help pregnant women quit smoking by testing the safety and efficacy of bupropion, a medication that has been shown to almost double the success rate of smoking cessation in nonpregnant smokers. Pregnant women who smoke are at risk for premature rupture of membranes, low birth weight, and infant mortality.
A new study by University of British Columbia researcher Mahyar Etminan found that newer oral contraceptive drospirenone carries a similar risk of gall bladder disease compared to older birth-control pills. The study analyzed data from 2.7 million U.S. women using oral contraceptives over 18 months.
The Canadian Medical Association Journal advocates for reforming Canada's outdated food and drugs act to ensure new and old medications are safe and effective. The proposed reforms include increased evidence gathering, monitoring, progressive licensing, and modernizing legislation.
A University of Missouri chemist has discovered a method for manufacturing certain pharmaceutical drugs using pressurized carbon dioxide at room temperature. This new approach could streamline production processes and reduce the need for expensive and time-consuming methods currently used in the industry.
Medications like Vioxx, Bextra, and Avandia increase heart attack and stroke risk due to fluid retention. The study suggests the FDA should require verification of cardiovascular safety for all medications causing fluid retention.
A systematic review found that biologic drugs used to treat arthritis may have rare but serious side effects, including increased risk of infections and cancer. The study analyzed data from 163 studies involving over 50,000 patients, highlighting the importance of comparative safety research.
A pharmacist-directed anticoagulation service improved the management of heparin-induced thrombocytopenia (HIT) in patients. Patients treated by the service responded to alternative anticoagulant drugs three times faster, and were 32% more likely to receive proper dosing.
A study found that 15 out of 20 drug classes had inconsistent black box warnings, with some warnings missing from all drugs in the same class. The researchers argue for a more transparent and systematic approach to label design.
The study highlights the risk of dosing errors in pediatric medication, particularly with potent narcotics and sedatives. Researchers found that over a quarter of children studied experienced errors resulting from small volume stock solutions.
A recent study from the University of Texas Medical Branch at Galveston found that aggressively marketed drugs tend to offer less benefit and more harm to most patients. The 'inverse benefit law' highlights the need for physicians to critically evaluate commercial marketing and prioritize patient safety.
A commentary highlights the shortcomings of Canada's current drug surveillance system, citing the off-label use of recombinant activated factor 7 (rFVIIa) as a case in point. The authors emphasize the need for improved collaboration between payers, insurers, and manufacturers to ensure safe monitoring of high-risk drugs.
A new study by Stanford researchers found that many prescriptions for atypical antipsychotic medications lack strong evidence, yet these drugs can cause serious side effects like weight gain, diabetes, and heart disease. The study also identified a significant amount of off-label use, with $6 billion spent on such prescriptions in 2008.