Articles tagged with Drug Safety
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Scientists are conducting a Phase 1 clinical trial of EDP-788, an oral antibiotic targeting methicillin-resistant Staphylococcus aureus (MRSA) infections. The trial will evaluate the safety and pharmacokinetics of the drug in healthy participants.
A study examines reasons for delay and denial of new drugs by the FDA, finding that preventable deficiencies in clinical trials account for significant delays. The study highlights the need for early dialogue between the FDA and drug sponsors to improve drug development strategies.
The FDA's premarket approval process for cardiac implantable devices allows for incremental innovation with minimal data collection. The study found that 37% of supplements represented minor alterations to device design or materials, and only 23% included new clinical data.
A study published in JAMA found that more than one-third of FDA-approved drugs were approved based on a single clinical trial, without replication. The study analyzed the strength of clinical trial evidence supporting drug approvals from 2005 to 2012 and found significant variability in trial design and duration.
A study by researchers found that only 46% of neonatal labeling changes made clear the drug was approved for safety and effectiveness in infants. Few drugs were used in neonatal intensive care units (NICUs) with most studied drugs not tested in over 60 neonates.
Researchers at University of British Columbia and Vancouver Coastal Health study show that a combination asthma therapy does not harm British Columbians, contradicting FDA safety concerns. The study, covering 46,000 people over 15 years, found no statistically significant increase in hospitalization rates for users.
A Vanderbilt study found that women with chronic autoimmune diseases who take immunosuppressive medications during their first trimester of pregnancy are not putting their babies at significantly increased risk of adverse outcomes. The study included over 600 infants and used health plan data from three geographically diverse health pl...
Researchers will examine conversion to generic tacrolimus in transplant patients to assess its safety and efficacy. The studies aim to address concerns about the use of generic tacrolimus formulations in transplant recipients and provide objective data for clinicians.
A clinical trial found gabapentin to be safe and effective in treating alcohol dependence, reducing cravings, depression, and sleeplessness. The drug's effect on drinking outcomes was at least as large as existing FDA-approved treatments, with significant benefits seen in patients who received the high-dose regimen.
Researchers at Washington University School of Medicine are studying the quality and effectiveness of generic drugs for treating depression. They aim to determine if generic versions of bupropion HCl ER tablets work as well as brand-name Wellbutrin XL in treating depression, with a focus on safety and potential side effects.
A study examined expedited FDA drug approvals, finding that new drugs approved under accelerated review took a median of 5.1 years to get marketing approval compared to 7.5 years for standard-reviewed drugs. Fewer patients were studied in these expedited reviews, raising concerns over the safety and efficacy of these medications.
Researchers at UTHealth successfully tested a hands-free ultrasound device combined with clot-busting drug tissue plasminogen activator (tPA) in ischemic stroke patients, showing promising results. The device improved outcomes by 65% and enabled some patients to recover without significant disability.
A hands-free ultrasound device combined with a clot-busting drug was safe and effective in treating ischemic stroke patients, with 65% returning home or to rehabilitation. The technology opens up more arteries in the brain, helping stroke patients recover, according to researchers.
A study found that nearly all nurses who used mobile devices to look up drug information prevented at least one adverse event. The use of these tools improved patient safety and reduced healthcare costs, with estimated savings of $4 billion annually.
A team of researchers at Mount Sinai used systems biology and big data analysis to find that combining diabetes drug rosiglitazone with exanatide reduced heart attacks. The approach identifies potential safer combinations, sparking interest in repurposing FDA-approved drugs.
A new study at Columbia University's Mailman School of Public Health found that drivers who test positive for drugs are three times more likely to be involved in a fatal crash. The study also showed that the combination of alcohol and drugs increases the risk by 23 times, making drugged driving a critical safety issue.
A new study by St. Michael's Hospital researchers found that cognitive enhancers do not improve cognition or function in people with mild cognitive impairment in the long term. Patients on these medications experienced significantly more nausea, diarrhea, vomiting, and headaches, highlighting the potential risks of these drugs.
A new study shows that using electronic data to monitor medicine dosing led to a substantial reduction in missed or delayed doses. The study found that 'technovigilance' – turning data into intelligence – can help improve patient safety and reduce errors.
A new study from Boston University's Slone Epidemiology Center found no evidence to support suggestions of increased risks of certain birth defects associated with antihistamine use in pregnancy. The study considered over 20,000 new mothers and commonly-used antihistamines available OTC or by prescription.
Researchers have made a breakthrough in developing better tests for liver toxicity, which could lead to safer medicines and more drugs reaching patients. The new tests can detect liver damage without causing permanent harm, allowing patients to continue taking medications.
A study found that a fifth of US neurologists are unaware of serious drug safety risks associated with anti-epilepsy drugs, which can jeopardize patient health. The researchers suggest better communication from the FDA to specialists and more systematic methods for doctors to receive updated safety warnings.
A University of Cincinnati-led trial has shown that combining the clot-busting drug tPA with an antiplatelet medication eptifibatide dissolves blood clots more quickly and safely than tPA alone. The study found that 50% of patients treated with both drugs had good outcomes, compared to 36% of those receiving tPA alone.
A meta-analysis of Chinese herbal medicines for vascular dementia found that these treatments appear to be safer and more effective than control measures. The studies suggest that Chinese herbal medicine has good potential in the clinic for treating vascular dementia.
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.