Articles tagged with Drug Safety
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Comprehensive examination of tools, techniques, methodologies, and approaches used across scientific disciplines to conduct research, collect data, and analyze results. Encompasses experimental procedures, analytical methods, measurement techniques, instrumentation, imaging technologies, spectroscopic methods, laboratory protocols, observational studies, statistical analysis, computational methods, data visualization, quality control, and methodological innovations. Addresses the practical techniques and theoretical frameworks enabling scientists to investigate phenomena, test hypotheses, gather evidence, ensure reproducibility, and generate reliable knowledge through systematic, rigorous investigation across all areas of scientific inquiry.
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A new study published in CMAJ found that patients receiving drug eluting stents had better outcomes, including lower mortality rates, compared to those with bare metal stents. However, the study also noted an increased risk of repeat revascularization procedures or death after three years.
Lack of data on statin safety and efficacy in children and youth raises concerns about potential risks. Experts recommend caution and alternative management tools, citing the need for further research.
The UAB Center will examine the risks and benefits of eight biologics used for autoimmune disorders, including women, children, minorities, and the disabled. The study aims to boost understanding of these drugs and guide medical professionals, manufacturers, and regulatory agencies.
A novel topical treatment for cold sores has demonstrated equivalent efficacy to oral systemic drugs without safety or toxicity concerns. The treatment, NB-001, speeds up healing of lesions by 1.3 days and is well-tolerated with no adverse events.
A meta-analysis of 40 clinical trials found that metformin hydrochloride was associated with a decreased risk of cardiovascular mortality compared to other oral diabetes agents or placebo. However, the study did not find significant associations between other diabetes medications and beneficial or harmful cardiovascular effects.
According to a study published in JAMA, approximately one in four approved biological medicinal products had at least one safety-related regulatory action issued 10 years after their approval. The average time to a safety-related regulatory action was 3.7 years, with 70.7% of actions occurring within five years after approval.
Rutgers University has received a $2.3 million federal grant to lead a national study on the use, safety, and effectiveness of antipsychotic medications. The study will focus on subpopulations such as the elderly and youth, where evidence is incomplete on medication outcomes.
A safety and efficacy study found tribendimidine to be effective against hookworm, large roundworm, whipworm, threadworm, and tapeworm infections. The new drug cured up to 92% of soil-transmitted helminth infections in a highly endemic setting in China.
A new drug class, ranolazine, has been approved for the treatment of chronic stable angina, providing a safe and effective alternative to existing treatments. Ranolazine has been shown to reduce anginal episodes by one attack per week and extend exercise time before an angina attack develops, with benefits seen in men more than women.
A study by Lifespan and Hasbro Children's Hospital found that nearly one in 10 American children received free drug samples in 2004. The top four most frequently distributed medications have significant new safety concerns, including schedule II controlled substances that carry high potential for abuse.
Research from the University of Missouri has shown a significant relationship between BPA exposure and cardiovascular disease, type 2 diabetes, and liver enzyme abnormalities. The FDA is urged to take action to reduce human and environmental exposures to BPA due to its adverse health effects.
A new study from Northwestern University's Feinberg School of Medicine found that ipratropium increases the risk of heart attack or arrhythmia by 34% compared to albuterol or no treatment. The study suggests that the medication may have a systemic cardiovascular effect, increasing mortality risk in COPD patients.
The SITS-ISTR study found that alteplase was safe and effective when given 3-4.5 hours after stroke onset, similar to the traditional 3-hour treatment window. Outcome measures were comparable in both groups, with similar mortality rates, brain haemorrhage risk, and independence at 3 months.
A new study highlights the need to develop systems to assess antimalarial drug safety in early pregnancy, as artemisinins have been shown to be toxic to embryos in animal models. An international antimalarial pregnancy exposure registry is proposed to enable targeted pharmacovigilance and timely assessment of risk-benefit profiles.
Researchers analyzed 67 pediatric drugs, finding nearly 1 in 5 required label changes due to life-threatening adverse events. The study highlights the importance of post-marketing surveillance for pediatric safety.
A study found that one-fifth of Ayurvedic medicines purchased online exceed acceptable standards for lead, mercury, and arsenic. Rasa shastra medicines were more likely to contain detectable metals, posing a risk to users.
A study analyzing prescription data found that anti-psychotic drug use increased by 20% among elderly patients with dementia after safety warnings were issued. The warnings, issued between 2002 and 2007, aimed to reduce the risk of stroke or death associated with these drugs.
A recent study published in Clinical Infectious Diseases reveals that adverse reactions to antibiotics cause an estimated 142,000 emergency department visits per year in the United States. The majority of these reactions are allergic, with over 80% being related to penicillins and other antibiotics.
A study found that rituximab significantly reduces kidney injury in patients with membranous nephropathy, reversing functional and biological abnormalities. The treatment achieved complete remission in 10 patients, including significant healing of kidney damage.
Scientists at NIST have developed a technique to accurately measure the formation of protein clumps in biologic drugs, addressing a major concern for quality control and safety. The new method uses electrospray differential mobility analysis (ES-DMA) to quickly resolve particle sizes differing by as little as 0.2 nanometers.
Researchers analyzed medication orders that were withdrawn within 45 minutes and found a 66% rate of errors. The study suggests a systematic method for identifying prescribing errors, which can be used to screen for errors and as a teaching tool.
Researchers at UNC have identified specific prescription drugs that increase the risk of falls for patients aged 65 and older who take four or more medications. These medications, including antidepressants and painkillers, work to depress the central nervous system, making patients less alert and slower to react.
A long-term safety study on Lialda found that the medication is generally well-tolerated, with most adverse events being mild or moderate in intensity. The study also showed that a majority of patients remained in remission for 12 months.
A study found that war veterans with insomnia preferred a combination of relaxation therapy, stimulus control instructions, and sleep education. The veterans also favored electronic approaches such as MP3 files and the Internet to deliver non-pharmacological treatment.
A new technology developed by University of Leeds engineers can monitor crystals as they form in drug manufacture, providing a method to ensure production of desired drug compounds. This can lead to huge delays and costly challenges for drug companies, but the technology has enormous commercial potential.
A new treatment using tissue plasminogen activator (tPA) has dramatically decreased death and disability in patients with intracerebral hemorrhage (ICH), a condition where blood clots inside the brain. The treatment, which clears trapped blood from the brain, showed an 80% survival rate for patients.
A new calcineurin inhibitor ISA247 has been shown to be safe and effective in treating moderate to severe psoriasis. The study found a strong correlation between drug dose and response, allowing for more accurate dosing to minimize side effects.
A recent study found that new anti-TNFα drugs are better than standard treatments for RA, with patients experiencing improved response when combined with methotrexate therapy. However, these drugs also have a higher frequency of adverse side effects, particularly at high doses.
Researchers explore a new approach to treating epilepsy by using the diabetes drug metformine, which targets metabolic pathways similar to a ketogenic diet. The study's findings suggest that metformine may suppress over-active nerve cells by removing excess energy production.
The FDA's proposed guidelines would reduce oversight of off-label drug use, allowing companies to market more drugs for unapproved uses. Stanford researcher Randall Stafford criticizes this move, arguing that physician judgment is critical and that evidence-based practice should be prioritized.
Research at Harvard University found that drugs approved on tight FDA deadlines are more likely to face later regulatory action for safety concerns. The study suggests that a more flexible approval protocol could improve drug safety and reduce rushed approvals.
Researchers have identified promising new drug targets for Huntington's disease, which can stimulate autophagy and alleviate the toxicity of malformed proteins. Candidate drugs include verapamil and clonidine, which have been shown to be safe and effective in cell-based models.
A major review found that only two per cent of paediatric drug trials had independent safety monitoring committees to detect adverse drug reactions. Clinical drug trials in children are essential for developing medicines and treatments, but greater safety measures and awareness are needed.
A review of over 700 pediatric drug trials found that only 13 studies had independent safety monitoring committees. The trials reported various adverse events and reactions, highlighting the need for greater safety measures and awareness in clinical trials involving children.
A survey of 3,639 college students found that those who used prescription medications without a prescription were more likely to screen positive for drug abuse than those who used them for medical reasons. The study highlights the importance of proper diagnosis and treatment of college students taking frequently abused medications.
The MIT-developed thin-film coating can deliver precise, remote-controlled doses of drugs to specific targets in the body. The film is made from alternating layers of materials and can be activated by applying a small electric field.
Researchers at Duke University Medical Center tested the novel drug KAI-9803 in a clinical trial, finding promising signs of beneficial activity. Early data suggest that KAI-9803 may limit damage caused by reperfusion injury following PCI.
A new study in Zanzibar has shown the safety of delivering three antiparasitic drugs simultaneously to tackle three diseases. The co-administration of ivermectin, albendazole, and praziquantel was found to be safe and effective in reducing distribution costs and increasing community participation.
A device designed to eliminate mixing errors in children's medications was tested at C.S. Mott Children's Hospital and found to be 100% accurate. The technology uses enhanced photoemission spectroscopy to verify the formulations of intravenous drugs, reducing potential medication errors.
A new study by Cambridge University found that doctors treating life-threatening emergencies like allergy attacks often give the wrong dosage of adrenaline because of confusing labelling. The researchers discovered that this can lead to dosing errors and delays in administering the drug.
A physician-scientist is urging improved drug regulation to ensure the cardiovascular safety of non-heart drugs. This includes earlier testing and continued evaluation of drug effects post-approval.
Two clinical trials demonstrated that Perforomist Inhalation Solution is a safe and effective treatment for moderate-to-severe COPD. The studies found no significant increases in cardiovascular events or adverse effects, making it a welcome addition to the physician's arsenal.
The University of Illinois Chicago has established a new center to study how consumers and clinicians make critical treatment decisions about therapeutic products. The center will design and test systems to optimize drug choice, monitoring, and safety, with the goal of improving healthcare outcomes.
A new communication tool, VMS, improves the effectiveness of medication instructions and reduces complications among patients taking warfarin. The study found that VMS worked especially well among Spanish-speaking patients, correcting misunderstandings within 28 days.
A meta-analysis of pioglitazone treatment found a significant reduction in heart attack, stroke, and death rates among type 2 diabetes patients, with no significant increase in cardiovascular death. However, the treatment also increased the risk for serious heart failure.
Between 1998 and 2005, serious adverse drug events doubled, resulting in a significant increase in deaths associated with adverse drug events. The study found that pain medications and immune-modifying drugs contributed disproportionately to fatal events.
A study published in Archives of Internal Medicine found a significant increase in adverse drug events reported to the FDA between 1998 and 2005. The number of serious adverse drug events nearly tripled, while adverse drug-related deaths increased 2.7-fold during this period.
A study is underway to determine best practices for reducing non-intercepted medication errors, which result in over 7,000 inpatient deaths per year. The study aims to identify factors that contribute to the failure of nurses' efforts to intercept medication errors.
A report by the March of Dimes Foundation reveals that 122 pregnancies were exposed to Accutane despite a mandatory risk management program. The program, known as iPledge, aims to prevent pregnant women from being exposed to isotretinoin, a known teratogen.
A study of nearly 8,000 children found a significant rise in the prescribing of newer antiepileptic drugs, with concerns over their long-term safety. The research highlights the need for greater investment in paediatric drug development and testing.
A new study by Northwestern University's Charles Bennett found that RADAR identified serious drug reactions six years earlier than the FDA and drug companies. The team's proactive safety efforts provided doctors with important medical insights and guidance for prevention, diagnosis, and treatment.
In Italy, general practitioners receive frequent visits from drug sales reps, who provide information that doctors often consider reliable. A national continuing medical education program aims to disseminate independent, unbiased evidence through Clinical Evidence, a compendium of the best available research on treating common conditions.
The FDA has added 'black box' warnings to all prescription and over-the-counter pain relievers, despite evidence showing naproxen is safe. This decision ignores the risk differences between nonsteroidal anti-inflammatory drugs, with Voltaren carrying the highest risk of heart attack.
A study published in PLOS Medicine found that detailed visits by drug representatives can lead to increased prescribing of gabapentin for non-approved uses. Doctors reported a substantial proportion of visits contained messages on non-approved uses, with many stating an intention to increase their use of the drug.
A new asthma inhaler propellant is safe and effective, but its higher cost will significantly impact consumers and healthcare systems. The switch from chlorofluorocarbon (CFC) to hydrofluoroalkane (HFA) propellant may lead to increased costs for patients with prescription benefit plans, as well as co-pays.
The study found that the novel PPAR-alpha agonist LY518674 decreased triglycerides and increased HDL-C levels, but also raised safety concerns such as increased serum creatinine levels and cardiovascular toxicity. The results were generally similar to those of existing drugs like fenofibrate.
A new analysis suggests that allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review recommends changes to the FDA's policy, including a heavier burden of proof and comprehensive public disclosure.
Recent IOM recommendations lack evidence to support claims of a drug safety crisis. A new editorial questions the science behind these reforms, citing a study on the benefits of reduced approval times over safety concerns.
A new study found that patients who received aprotinin during coronary artery bypass graft surgery had a higher risk of death over five years compared to those who did not receive the drug. The study, published in JAMA, also found that safer alternatives like aminocaproic acid and tranexamic acid were available.
A new study published in The Annals of Pharmacotherapy found that phenylephrine may not be as effective as previously thought, with some studies showing no significant benefit. The study's findings suggest that higher doses of the drug could increase the risk of adverse effects, and the FDA is urged to require additional research.