Articles tagged with Drug Safety
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A recent study found that 32% of newer drugs received a black box warning or were withdrawn for safety reasons, compared to 21.2% of older drugs.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 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.