Articles tagged with Drug Safety
Researchers replicated human-like drug responses in TARA's engineered heart-on-a-chip system, predicting cardiac safety and efficacy. The study validated the platform's ability to model different heart diseases and measure contractile force of Cardiotype tissues.
Researchers found ivacaftor significantly reduces P. aeruginosa, Staphylococcus aureus and Aspergillus spp. infections in CF patients, with a 32% reduction in P. aeruginosa and 15% reduction in Staphylococcus aureus.
Since President Trump took office, FDA warning letters have fallen by a third, with significantly fewer issued during his second year. The decline in enforcement actions raises concerns among agency watchers and experts, who find the trend alarming despite the FDA's claim of ongoing regulatory efforts.
A University of Queensland researcher calls for the PBS to update its restrictions on anti-epileptic drugs to ensure safe and up-to-date clinical practice. The current system fosters outdated prescribing practice and suboptimal care.
A new poll suggests that many grandparents are storing their medications in easy-to-reach places, posing a risk of accidental poisoning or intentional misuse. The poll found that nearly 80% of grandparents keep their medications in the same place as usual when their grandchildren visit, and 72% store them in purses or bags.
A study published in JAMA Ophthalmology found that one-third of ophthalmic patients have discrepancies between clinician notes and EHR-generated medication lists. This inconsistency may lead to avoidable medication errors, threatening patient safety.
Researchers tested a medication reservoir implant in 220 patients with wet age-related macular degeneration, finding it safe and effective in reducing the need for injections. The study showed significant improvements in eyesight, with patients able to see farther than before, and a longer time between refills.
A large majority of people who use heroin and fentanyl are willing to use safe consumption spaces where they can obtain sterile syringes and medical support in case of overdose. The study found that 77% of participants reported a willingness to use such spaces, with higher rates among those who rely on public spaces.
Researchers exposed commonly used anaesthetic drugs to Antarctic weather conditions and found that they were within the allowed security margins, making them safe for use. The study provides reassurance for anaesthetists working in challenging environments.
A Canadian Medical Association Journal editorial argues that the Motherisk program should be reinvented to support healthy pregnancies and births. The proposed program would involve collaboration among clinical experts, front-line providers, and health organizations to ensure responsible conduct and independence from industry.
Seven former FDA commissioners and a new paper suggest the FDA should become an independent agency to protect science-based drug safety decisions from political interference. The authors propose safeguards, including six-year terms for commissioners and budgetary independence, to ensure the agency's mission is upheld.
A team at KAUST developed a stretchy sensor that can detect temperature and humidity, enabling the creation of smart pill bottles with tamper alerts and safe storage conditions. The technology has potential applications in improving traditional approaches to healthcare issues, making sensors more accessible to low-income populations.
Researchers have successfully lowered levels of mutant huntingtin protein in patients with Huntington disease, making the treatment safe and well-tolerated. The trial enrolled 46 patients and found significant decreases in disease-causing protein levels without serious adverse reactions.
The University of Houston College of Pharmacy has opened a new center to educate providers and patients on safe controlled substance prescription use, aiming to optimize pharmacotherapy for pain management. The PREMIER Center will also support the safe disposal of unused medications through a $3.34 million grant.
A new international study found that regulators in four countries - including Canada - were only consistent in the decision to warn about potential drug safety risks 10% of the time. This lack of consistency highlights a need for better communication of important drug safety notices.
The federal right-to-try law has been criticized for undermining the FDA's role in monitoring drug safety and efficacy, potentially creating a loophole for pharmaceutical companies to sell unapproved drugs. In contrast, citizen science and gamification are changing the way research is conducted, with nonprofessional volunteers contribu...
A small study found that cilostazol and isosorbide mononitrate treatments were safe for patients with strokes caused by damaged small blood vessels. The drugs may help improve blood vessel function and potentially reduce the risk of stroke and vascular dementia.
The Innovative Medicines Initiative has launched a five-year project to generate exploratory and confirmatory data for novel safety biomarkers. This will improve the diagnosis and management of acute and chronic diseases, as well as reduce safety attrition in drug development.
A study published in Alimentary Pharmacology & Therapeutics found that older patients with Crohn's disease can be safely treated with combined immunosuppression. The research showed that remission rates were similar between older and younger patients, and there was no increase in side effects in older patients.
A NYU study has identified medication management challenges faced by home health care providers, including communication breakdowns and fragmented systems of care. The researchers found that medication errors, such as taking the wrong drug or dose, were common among high-risk patients living alone.
A new study found a link between Celebrex and heart valve calcification, contradicting previous findings that declared the drug safe. The study analyzed patient records at Vanderbilt University Medical Center and found a 20% increased prevalence of valve disease among those who took Celebrex.
A new study found over 1,800 calls to US Poison Control Centers regarding kratom exposures from 2011-2017, with a dramatic increase in annual calls. The majority of exposures were among males and occurred at residences, often due to intentional abuse or misuse.
A new study from Johns Hopkins Bloomberg School of Public Health explores the experiences of early efforts to establish safe consumption sites in five US communities. The research highlights key lessons learned, including the importance of engaging diverse community partners and securing political champions.
A new medicine under development, vamorolone, shows improved safety in treating both inflammation and heart disease in experimental models of DMD. This is significant because the current standard of care, prednisone, reduces chronic inflammation but has harsh side effects.
A new review by UBC researchers found that up to one-third of pregnant women do not believe cannabis is harmful to their fetus. The study suggests that perceptions about cannabis use influence decision-making among pregnant women. Women who used cannabis during pregnancy were more likely to be under 25, unemployed, or have low income a...
PCSK9 inhibitors significantly reduce Low-Density Lipoprotein Cholesterol (LDL-C) levels by more than 50-60% in patients with Familial Hypercholesterolemia (FH). The study also found that alirocumab reduces all-cause mortality compared to evolocumab, suggesting potential differences in cardiovascular outcomes.
A recent editorial emphasizes the importance of evidence-based treatment for opioid use disorder (OUD), highlighting the benefits of medications like methadone, buprenorphine, and naltrexone. Experts stress that these treatments should be evaluated like any other chronic illness, free from unnecessary regulations and biases.
A study by researchers at Idaho State University found that a quarter of chronic opioid users in Idaho were at risk for overdose from unsafe combinations of prescriptions. Pharmacists are urged to facilitate communication between prescribers and educate patients on the risks of these dangerous drug combinations.
Cytocybernetics is developing the Cybercyte for use with brain cells to study how drugs affect electrical activity in neurological disorders. The company will expand its focus beyond cardiac applications with the new funding.
A new study found that only about a third of mandatory pediatric post-marketing drug studies were completed within seven years, leading to a lack of child-specific information on medication labels. This perpetuates off-label prescribing that may be unsafe or ineffective for children.
Researchers have generated a novel mouse model with a humanized cereblon receptor to study the effects of immunomodulatory drugs. The new mice respond to treatment with these drugs, revealing distinct therapeutic pathways for immunomodulation.
A study on UK dairy farm medicines storage practices found most farmers store medicines appropriately, but with room for improvement. Inappropriate use and disposal of expired medicines are common, highlighting the need for open conversations between veterinarians and farmers.
A new study found that antiepileptic drug clearance significantly changes by the first trimester for one commonly used medication and by the second trimester for two others. The findings have implications for adjusting medication doses during pregnancy to keep women with epilepsy seizure-free and safe.
Scientists at Calibr have built a massive library of existing small-molecule drugs called ReFRAME, which shows promise for treating major diseases such as HIV and tuberculosis. Preliminary testing has identified two additional compounds effective against Cryptosporidium spp., offering a potential therapy for severe diarrhea.
A new USC study reveals that sudden price hikes for some generic drugs are becoming more common, reflecting emerging strategies by generic manufacturers to target therapeutic areas with limited competition. The study found that prices for most generic drugs declined over time, but the fraction of drugs with prices that at least doubled...
Psilocybin researchers propose moving the substance from a Schedule I classification to Schedule IV due to low potential for abuse and harm. This move would facilitate clinical trials and minimize logistical hurdles.
Researchers at Sanford Burnham Prebys Medical Discovery Institute have found that amodiaquine suppresses blood vessel formation through both the apelin and VEGF pathways, reversing vascular eye damage in animal models. The compound blocks the receptor's function by binding to a unique area, inhibiting apelin's ability to drive blood ve...
The authors explore clopidogrel's use in stable ischemic heart disease, acute coronary syndrome, stroke, and peripheral vascular disease. They evaluate the data behind its use in patients on oral anticoagulation, aiming to better understand its role in cardiovascular disease.
A new influenza drug, baloxavir marboxil, has been shown to significantly shorten the duration of flu symptoms in teens and adults, clearing virus more quickly than placebo. The drug's antiviral potency was found to be similar to that of a five-day course of oseltamivir, but with greater effectiveness and no significant side effects.
The PROFORMA project aims to strengthen national infrastructures for drugs safety monitoring in four East African countries. The five-year project, funded by EUR 6 million, includes training at Master's and postgraduate level and exchange of knowledge between researchers and experts.
Cynthia Connolly's book 'Children and Drug Safety: Balancing Risk and Protection in Twentieth Century America' received the APHA award for outstanding historical research and original contribution to science policy. The book explores the politics of pediatric drug safety and its impact on public health.
The authors propose increasing incentives and modifying regulations to improve competition, redirecting overinvestment in new drug development to the generic market, and pivoting from short-term survival mode to long-term organized responses. These solutions aim to enhance competition, provide patients with reliable access to vital dru...
Extended-release naltrexone helps HIV-positive individuals reduce their number of heavy drinking days and improve antiretroviral therapy adherence. The study found significant decreases in heavy drinking days among participants receiving naltrexone, but no effect on antiretroviral adherence.
US testosterone prescriptions dropped significantly following reports linking use to cardiovascular events. Between 2013-2016, new users saw a 62% decrease, while established users saw a 48% drop, according to the University of Texas Medical Branch at Galveston study.
A recent meta-analysis compared the efficacy and safety of antihypertensive drugs during pregnancy. Labetalol, hydralazine, and nifedipine were found to have similar efficacy with negligible differences in their safety profile.
A large study of over 10,000 pregnant women found no increased risk of stillbirth associated with fluconazole use. The results contradict earlier animal data suggesting a potential link between the drug and fetal death.
A recent study suggests that metformin is safe for most adults with diabetes and chronic kidney disease (CKD). The research, conducted by Johns Hopkins Medicine, found no association between metformin use and acidosis in patients with mild to moderate CKD. However, the risk of acidosis increased significantly among patients with severe...
A recent study found that one of the most widely prescribed antibiotics does not meet expected success rates, while another is as effective as newer drugs. The study suggests re-evaluating old antibiotics against modern standards to ensure patient well-being and restrict newer antibiotic use.
A new study found that administering edonerpic maleate, a small molecule targeting CRMP2, significantly improved the ability of mice and monkeys to regain motor function after a stroke. Early clinical trial results suggest the drug is safe in humans, offering a potential breakthrough for stroke recovery.
Anti-tumor necrosis factor medications like certolizumab pegol show a low rate of major congenital malformations and similar live birth rates to the general population. These findings support continued treatment with anti-TNFs for women with chronic inflammatory diseases during pregnancy
A new University of Bath project seeks to reduce injection errors, aiming for a 35% decrease in mistakes. The research, led by Dr Matthew Jones, will test modified guidance on nurses to improve patient safety and potentially save NHS time and money.
A 3D tissue model of the developing heart has been created using human induced pluripotent stem cells, allowing for more accurate and reliable drug safety testing for pregnant women. This model mimics early stage human heart development, providing a valuable tool for assessing embryo toxicity and fetal development.
A study published in Anesthesiology found that intravenous amisulpride significantly reduced post-operative nausea and vomiting in high-risk patients when used in combination with an anti-nausea treatment. Amisulpride showed a statistically significant reduction in PONV occurrence, without increasing the frequency of adverse events.
A recent study by researchers from UMass Amherst and Newcastle University found serious deficiencies in the evidence base for widely used diabetes drugs in India. The investigation calls for action to ensure these medications are safe and effective.
Scientists from ITMO University have developed a new treatment for internal bleeding using magnetically-driven nanoparticles containing thrombin. The treatment reduces overall blood loss by 15 times and accelerates local clot formation.
A new drug has shown encouraging safety and efficacy in treating Still's disease, a serious orphan condition. The treatment, which blocks the action of an inflammation factor, has been tested on 23 patients with refractory forms of the disease, resulting in positive responses and significant symptom reduction.
Researchers found that adding cetirizine to standard therapy significantly reduced annualized relapse rates in patients with neuromyelitis optica, a rare disease causing inflammation and demyelination. The study suggests that cetirizine may be beneficial in preventing relapses by modulating eosinophil activity.
Researchers at Newcastle University found that only two out of six essential medicines were easily available in private pharmacies, with many more listed in Indian databases but unaffordable. The study calls for a review of available brands and the setting up of a centralized database to address inadequate access to essential medicines.
A recent study found that none of the 89 approved pediatric drug products include dosing information for obese kids. Obesity affects how the body takes up medicine, where it retains it and how quickly it is excreted. More efforts are needed to provide safe dosing guidelines for children with obesity.
A new authentication method using direct ionization mass spectrometry has been developed by PolyU to quickly identify genuine and counterfeit species of Lingzhi and Tianma. The method can differentiate between wild and cultivated types, as well as geographical origins.