Articles tagged with Drug Safety
Despite improvements, more than 40% of postmarketing studies had not yet been started by 2011, and the proportion of fulfilled studies remains low. The number of studies with delays doubled to approximately 1 in 8 as of 2011.
The First-HD study examines the efficacy and safety of SD-809, a novel drug for treating chorea associated with Huntington Disease. The trial aims to test the tolerability of the drug in patients who have not previously taken tetrabenazine.
A University of Iowa study reveals significant disparities between minority and white clients in completing substance abuse treatment programs. Successful completion predicts greater likelihood of getting off drugs, abstinence from alcohol, and employment six and 12 months after treatment completion.
The lack of hard data on drug safety during pregnancy is leading to a doubling of deaths among mothers with underlying health conditions. Pregnant women are hesitant to take medications due to concerns about their developing baby, while doctors are also reluctant to prescribe due to limited evidence.
A joint investigation by BMJ and Channel 4 Dispatches found that evidence of potential harm from new diabetes drugs has not been fully published. This has led to millions of patients worldwide being under-informed about possible risks. Regulators in Europe and the US have faced criticism for their slow response to emerging concerns.
A new analysis by researchers at George Washington University School of Public Health and Health Services suggests that removing conflict-of-interest restrictions for FDA advisory panels could weaken the agency's review system. The 2012 law loosened these restrictions, allowing more industry-affiliated experts to serve on panels.
Hospitals should require mandatory physical examination, drug testing, or both before medical staff appointments. Random alcohol-drug testing programs and policies for routine testing in sentinel events leading to patient death are also recommended.
A new class of drug targeting skin cancer's genetic material has been successfully tested in humans for the first time. The drug, Dz13, was found to be safe and showed positive effects in reducing tumour growth and spread.
The Mayo Clinic has created an institution-wide electronic warning system to identify patients at risk of premature death due to prolonged QT intervals. The system alerts physicians when a patient's ECG shows an abnormal heart rhythm, and has been shown to reduce mortality rates by nearly four times.
A study found that sales representatives failed to provide information on common or serious side effects and the type of patients who should not use a medicine in 59% of promotions. Doctors in Toulouse were more likely to be informed about potential harms, suggesting stricter regulatory standards may improve transparency.
Researchers at Texas Biomed discovered that ten FDA-approved drugs showed activity against multiple bacteria and 24 against multiple viruses. Chloroquine, used to treat malaria, was found to be particularly effective against both anthrax and Ebola viruses.
A Phase 1 clinical trial tested an antisense treatment for ALS, blocking production of a mutated protein that causes the progressive neurodegenerative disease. The treatment was successfully distributed throughout the central nervous system and showed no serious adverse effects.
The UK government's decision to promote abstinence for drug users is being challenged by experts who claim it prioritizes cost savings over scientific evidence. The 'recovery model' encourages patients to reduce and stop all addictive drugs, despite overwhelming evidence showing that maintenance therapy is more effective.
A study found that medicines intended for chronic use lack sufficient patients to evaluate safety and efficacy. The number of patients studied before regulatory approval was often lower than recommended guidelines specify.
Albert Einstein College of Medicine researchers have been awarded a $12 million grant from the National Institutes of Health to develop a drug-impregnated intravaginal ring to prevent HIV infection in women. The device aims to provide safe and effective prevention strategies for women at increased risk of HIV infection.
Researchers analyzed 82 million drug-related search queries from 6 million users and found that those who searched for both drugs were more likely to look up symptoms associated with high blood sugar. This suggests that online searches could be used as an early warning system for potential drug safety issues.
Clinical guidelines suggest monitoring patients closely for harm using urine drug testing, pill counts, and prescription data. Careful management balances pain relief with the risk of addiction and overdose.
Patients with diabetes may receive high-dose cholesterol-lowering medications unnecessarily, increasing the risk of adverse side effects. The new study suggests adopting a more personalized treatment approach based on each patient's risk profile, combining blood pressure and prescription data in electronic records.
A Regenstrief Institute study found that over two-thirds of generic drugs have differing safety-warning labels from brand-name equivalents. The majority of discrepancies were small, but nine percent showed significant differences in side effects.
Healthcare professionals often view medication reconciliation as a 'checklist' task, but it's actually an opportunity to consider patients' entire therapeutic plans. Effective collaboration is key to ensuring patient safety and accuracy in medication regimens.
Pomalidomide, a new immunomodulatory drug, demonstrates significant increases in progression-free survival and overall survival for patients with relapsed and treatment-resistant multiple myeloma. The study found improved outcomes in both younger and older patients, offering a promising new option to extend survival.
The overprescription of opioids is contributing to increased fatal drug overdoses and diversion to the illegal market. Researchers recommend a shift towards alternative pain management approaches.
A study by Brigham and Women's Hospital found that 1.5% of discontinued medications are refilled by pharmacies, causing potential harm in 12% of cases. The researchers highlight the need for improved communication between providers and pharmacies to reconcile medication lists.
A study found that 96% of pediatric ICU patients received at least one off-label medication, highlighting the need for more studies on dosing, safety, and efficacy. The lack of drug data in children poses significant challenges to treating sick patients with confidence.
Compounded drugs lack FDA approval and may result in serious adverse events, highlighting the need for cautious prescribing decisions. Physicians should prioritize FDA-approved products over non-standard alternatives.
A recent study from York University found that drugs approved through Health Canada's accelerated review process are more likely to be withdrawn or earn serious safety warnings than those undergoing standard reviews. This is due to the faster review process potentially missing serious safety issues.
A new study suggests that NA-1, a neuroprotective agent, may reduce brain lesions and damage after stroke surgery. The research found significantly fewer lesions in patients who received the drug compared to those who received a saline control, although there was no difference in volume of lesions recorded.
A study reviews the efficacy and safety of inhaled drugs commonly used in ICU settings, including antibiotics and diuretics. The article discusses the challenges of aerosol drug delivery and advances in devices contributing to its increasing use and success.
A 'quality-by-design' mindset could improve dietary supplement safety, as it did in the automotive industry. Manufacturers must verify plant identities and follow good manufacturing practices to ensure product accuracy.
The Canadian Medical Association Journal raises questions about the safety of prescription drugs manufactured overseas, particularly from countries like India and China. Regulatory agencies are criticized for lacking transparency in inspection processes, leaving Canadians uncertain about the quality of their medications.
A commentary by former Institute of Medicine committee members highlights the need for increased postmarket oversight and an independent ethics advisory board to address ethical challenges in drug safety. The authors emphasize the responsibility of the FDA to research participants and the importance of clear informed consent processes.
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.