Articles tagged with Drug Safety
A new class of PCSK9 antibodies has been shown to reduce mortality, lower LDL-cholesterol, and improve cardiovascular outcomes in patients with dyslipidemia. The treatment was well-tolerated and proved safe, providing a promising alternative for those who do not respond to statins.
A study of 1,964 patients found extending natalizumab dosing up to 8 weeks is well-tolerated and effective in treating MS disease activity. No cases of progressive multifocal leukoencephalopathy were reported in the extended dosing group.
A global pandemic of fake medicines threatens decades of progress in combating HIV/AIDS, malaria, and tuberculosis. Up to 41% of drug samples studied failed to meet quality standards, highlighting the urgent need for improved surveillance and detection methods.
A new study published in Annals of Emergency Medicine has reevaluated the safety of droperidol for sedating emergency patients with acute behavioral disturbance. The study found that droperidol is effective and safe when used alone, but combinations with benzodiazepines may increase adverse effects.
A study found that cannabidiol, a non-psychoactive component of marijuana, significantly reduced seizures in children with severe epilepsy. The drug was shown to decrease seizures by an average of 54 percent and improve convulsive seizure activity. However, side effects were reported in 6% of participants.
A new investigation by The BMJ reveals that NHS doctors could prescribe the affordable and effective sight loss drug Avastin for patients with wet age-related macular degeneration. If allowed, this could release £102 million annually to reinvest in other frontline patient services.
The FDA approves new antibiotics with minimal evidence of efficacy against antimicrobial resistance. Despite this, industry and medical societies claim the drugs address the issue, sparking concerns over safety and efficacy standards.
A study published in the Journal of Patient Safety found that redesigned IV medication labels can significantly reduce the risk of medication errors in the operating room. The research used simulated surgical emergency scenarios and showed a higher correct selection rate with redesigned labels compared to standard labels.
A nationwide clinical trial found that Eylea performed better for those with moderate or worse vision loss, while Lucentis and Avastin performed similarly for people with mild DME. The study recruited 660 participants across the US, showing improved visual outcomes for patients treated with Eylea.
A clinical trial examined the safety and effectiveness of lisdexamfetamine in treating moderate to severe binge eating disorder. The study found that higher doses of lisdexamfetamine (50-70mg/day) were effective in decreasing binge-eating days and episodes, with a significant improvement in four-week cessation rates.
A phase 3 trial found zirconium cyclosilicate effectively lowered potassium levels to normal range and maintained them for up to 4 weeks. The treatment was well-tolerated and showed consistent results across patient subgroups, with 84% of patients achieving normal potassium levels within 24 hours.
A new study highlights the difficulty women with epilepsy face when becoming pregnant, as certain medications used to control seizures may be linked to developmental problems in children. The review of 28 studies found that children born to women who took sodium valproate had lower cognitive abilities than those whose mothers did not t...
A modified form of a medication called niclosamide may hold the key to battling type 2 diabetes by reducing liver fat and improving insulin function. The research aims to find a safe and practical way to diminish fat content in the liver, which could safely treat patients of all weights.
A National Institute for Occupational Safety and Health (NIOSH) study found that nearly 2,100 oncology nurses and healthcare personnel do not always follow recommended safe handling practices for antineoplastic drugs. The lack of adherence increases exposure risk to cancer-causing agents, leading to adverse health outcomes.
Researchers developed a new test that determines which drugs are unlikely to work by analyzing their structural similarity to naturally occurring substances. The 'rule of 0.5' shows a strong correlation between marketed drugs and metabolites, indicating that molecules with low similarity are unlikely to succeed.
Researchers have developed a novel drug capsule coated with tiny needles that can deliver drugs directly into the lining of the stomach, bypassing the need for injections. The capsules successfully delivered insulin to pigs, causing a faster and larger reduction in blood glucose levels than traditional injections.
Commentaries in Annals of Internal Medicine argue that Proposition 46's mandatory physician drug testing could deter help-seeking and reporting, potentially harming patients. The authors instead advocate for addressing physician impairment through more nuanced solutions.
A retrospective single-center study found that restarting infliximab therapy after a drug holiday is safe and effective for IBD patients. The average duration of infliximab holiday was 15 months. Patients who were in remission at the time infliximab was discontinued showed a 78 percent response rate at one year.
A federal law aimed at reducing the use of 'club drugs' has failed, and instead put users at greater risk due to reduced access to safety measures like medical help and free water. The RAVE Act, enacted in 2003, targeted club owners but hindered their ability to provide necessary services.
The 340B program is facing critical issues such as eligibility definition, compliance, and transparency. RAND researchers estimate that the program accounts for $6 billion in outpatient drug spending and provides savings of $1.6 billion for eligible safety net providers.
A recent study found that 32% of newer drugs received a black box warning or were withdrawn for safety reasons, compared to 21.2% of older drugs. The study suggests that the FDA's expedited approval process may have led to the release of unsafe drugs.
The mHealth app industry has tremendous potential to broaden access to medical treatment and control costs, but lacks sufficient regulation by the FDA. A study published in the New England Journal of Medicine notes that only about 100 out of 100,000 apps have been cleared by the FDA, while opponents see this as a deterrent to innovation.
A new investigation by The BMJ raises concerns about the top-selling blood-thinning drug dabigatran, citing withheld company information and potential flaws in regulatory decisions. Key findings suggest that monitoring blood levels could reduce major bleeding risks by up to 30-40%.
Research into bedaquiline, a new drug for multidrug-resistant tuberculosis (MDR-TB), should proceed cautiously in people with drug-sensitive tuberculosis. The drug has shown promising activity against MDR-TB but also presents safety concerns, including increased risk of liver and cardiac toxicity.
Researchers found that only five trials were focused specifically on drug safety, and 14 drugs were approved without condition-specific trials or trials in children. The study calls for increased regulatory emphasis on long-term safety and efficacy, particularly for chronic use medications.
The study's findings highlight the importance of API hydration in determining physical properties, such as stability and solubility. The research provides valuable insights into the mechanistic relationships between dehydration stages and lattice structure changes.
A CDC report documents outbreaks of infections caused by health care providers stealing or tampering with patients' medications. Over 100 infections and nearly 30,000 patients have been potentially exposed to bloodborne or bacterial pathogens over the past decade.
The FDA has approved medications that raise blood pressure, increasing the risk of heart attacks and strokes, despite inadequate safety data. The agency is urged to establish guidelines and require pharmaceutical companies to provide cardiovascular safety data on these medications.
A phase I study found that alisertib inhibited aurora A kinase, a target for aggressive lymphoma treatment, in about one-third of patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia. The oral drug showed manageable side effects, paving the way for advanced trials.
The study demonstrates BioMAP Systems' effectiveness in identifying potential toxicities and off-target effects of drugs and chemicals. The approach can reproducibly pinpoint cellular mechanisms and biomarker endpoints underlying specific adverse reactions in humans.
At least 1 in 20 adult outpatients is misdiagnosed every year, affecting 12 million people nationwide. Half of these errors could be potentially harmful, according to research published in BMJ Quality & Safety.
A new study from the University of Vermont aims to provide timely access to effective treatment for Vermont's waited-listed opioid-dependent individuals. The treatment 'package' involves five key components, including buprenorphine maintenance therapy and innovative technology for safe medication administration.
A four-year study of over 3,000 opinions on Spanish web pages found that communication strategies aimed at creating risk perceptions about generic drugs may influence their low usage. Generic drugs have the same composition, quality, and safety as brand-name counterparts, yet their market share in Spain is lower than in Europe.
A team led by Robert Linhardt and Jian Liu created a synthetic form of low-molecular-weight heparin, which can be reversed in cases of overdose and is safer for patients with poor kidney function. The new drug is also cost-effective and has improved properties compared to the animal-derived alternative.
Two approved weight-loss drugs have been linked to serious harms, including memory and depression problems, and cardiovascular risks. Researchers question the FDA's decision to approve these medications without more definitive evidence.
The FDA has approved a new multiple sclerosis treatment regimen developed at Wayne State University, which involves injecting Copaxone at a higher dose but fewer times per week. The study demonstrated that this dosing regimen is effective and safe, with reduced relapse rates and improved tolerability.
The Medical Research Council Centre for Drug Safety Science at the University of Liverpool has received £3m in new funding to continue reducing the impact of adverse reactions to medicinal drugs. Adverse drug reactions result in significant healthcare costs and pose a major challenge for the pharmaceutical industry.
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 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.
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.
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.