Articles tagged with Drug Safety
A new study in CMAJ reports that oseltamivir and zanamivir are relatively safe for use in pregnant and breast-feeding women during the H1N1 pandemic. Pregnant women, especially those in the third trimester, are at high risk of serious complications from the flu virus.
Researchers have found that humans are likely exposed to a daily dose of bisphenol A (BPA) that far exceeds the current estimated safe daily intake dose. The study, which involved five female adult monkeys, suggests that BPA exposure comes from multiple unknown sources beyond food and beverage containers.
A large cohort study found that metoclopramide poses no significant risks for fetal development when used to relieve morning sickness nausea, supporting its safe use during pregnancy. The study analyzed data from over 80,000 infants born to mothers who received the medication during the first trimester.
A legal loophole in Canada's advertising regulations has exposed Canadians to more than $90 million worth of drug ads, including those for life-threatening medications. The study found that four out of eight heavily advertised drugs had black box warnings and five had been subject to Health Canada safety advisories.
A pooled analysis of two studies found significant improvements in pulmonary function, dyspnea, and rescue medication use when Perforomist Inhalation Solution was added to maintenance tiotropium. Patient satisfaction also increased with twice-daily Perforomist Inhalation Solution compared to ipratropium/albuterol metered-dose inhaler.
The SCAAR registry study analyzed 47,967 patients who received drug eluting stents (DES) between 2003 and 2006. The results found no significant difference in late mortality between DES and bare metal stent (BMS) groups.
A new method for testing drugs predicts toxicity in some people, with genetic variations being key factor. The approach has potential to improve the development process and reduce costs.
A University of Rochester Medical Center survey found teens lack knowledge about over-the-counter pain medications, with only 35% correctly identifying acetaminophen and Tylenol. Chronic misuse can lead to liver damage and accidental overdose
Medication errors in the ICU account for 78% of serious medical errors. Implementing strategies such as computerizing orders, reconciling medications, and maintaining detailed medication lists can help prevent errors and improve patient safety.
A steroid nasal wash containing budesonide appears to reduce symptoms of chronic rhinosinusitis in patients. The medication is found to be safe and effective for short-term use, with minimal risk of systemic adverse effects.
A recent study found that Phase I drug trials are underreported, with only 17% published in scientific journals. The lack of transparency can compromise the safety and efficacy of new drugs, highlighting the need for increased mechanisms to ensure complete availability of trial results.
A new study found that clinicians override over 90% of drug interaction and allergy alerts, highlighting the need for improved decision support systems to enhance patient safety. The researchers recommend reclassifying alert severity, providing an option to suppress alerts, and customizing them for a clinician's specialty.
A new study by Queen's University Belfast emphasizes the importance of licensed medicines for children, with 86% of respondents unaware of unlicensed medicine use. The study calls for more clinical trials to ensure safe and effective treatment, highlighting a need to bridge the gap between adult and child medicine.
A vascular drug has improved spatial learning and working memory in middle-aged rats, suggesting potential benefits for cognitive function in humans. The findings support the use of the drug as a cognitive enhancer for age- or neurodegenerative-related memory dysfunction.
A survey of healthcare professionals revealed overwhelmingly negative opinions on proposals to switch trimethoprim and tamsulosin to over-the-counter availability. Concerns about antibiotic resistance, misdiagnosis, and potential misuse led to strong opposition.
Several herbal remedies commonly used for menopausal symptoms, such as black cohosh and red clover, lack strong evidence supporting their effectiveness. The study highlights the need for better-designed trials to assess the safety and efficacy of these herbal products.
Phylonix Pharmaceuticals has been awarded a Phase II SBIR grant from the NIH to develop high-throughput in vivo zebrafish assays for assessing Cytochrome P450 drug metabolism and safety. The assay will accelerate drug metabolism and safety profiling, reducing costly late-stage development failures.
A study found that 2.2 million older US adults take multiple medications, with half involving nonprescription medications, increasing the risk of harmful drug-drug interactions. The most common interaction was bleeding problems, often caused by combining prescription and over-the-counter medications.
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 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 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 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.