Articles tagged with Drug Safety
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.
Limited trials on obesity drugs have failed to show major reductions in related morbidity and mortality. The authors call for longer trial durations to ensure the development of safe and effective treatments.
Dextromethorphan abuse among California teens increased tenfold between 1999 and 2004, with 74.5% of cases involving youth aged 9-17. The trend was attributed to easy access and perceived safety of the medication.
The study found a potential increased risk of cardiovascular events among elderly individuals taking naproxen, while celecoxib showed no significant risk. The results contribute to the larger body of evidence on the safety of these non-steroidal anti-inflammatory drugs.
A review of Clostridium sordellii infections suggests that the connection between mifepristone and misoprostol in medically induced abortions is unclear. Despite four reported deaths, nearly 2 million European women have used mifepristone without C. sordellii infections. Further research is needed to identify factors that predispose to...
A new study finds methylphenidate, a widely prescribed ADHD drug, to be safe and effective in preschoolers when used at low doses. However, younger children may experience slower growth rates and side effects such as irritability and weight loss.
A study by Saint Louis University researchers found that heart failure drug use plummeted after two negative articles were published in prominent medical journals. The study showed that doctors quickly changed their treatment practices when confronted with potential safety risks, highlighting the significant influence of medical public...
African trial finds amodiaquine a safe and effective treatment for malaria in pregnant women, overcoming resistance to chloroquine and SP. The study suggests amodiaquine alone or in combination with sulphadoxine-pyrimethamine as an effective option for malaria treatment until artesunate-based therapy is deemed safe.
Five experts recommend Congressional action to address eight major problems, including inadequate funding and expertise. They propose five key changes to strengthen FDA's ability to assure public safety.
Researchers will analyze FDA database of electrocardiograms to identify early predictors of cardiac risk and develop new biomarkers for drug toxicity. The goal is to improve the safety of new drugs while reducing development costs.
A study by Duke University Medical Center researchers found that fewer than half of pediatric exclusivity studies were published in peer-reviewed journals, and the results were less likely to be published if the drug was deemed unsafe or ineffective in children. This lack of transparency can lead to detrimental patient care.
A new study published in the New England Journal of Medicine found that a specific drug, enoxaparin, significantly reduces major bleeding risks during stent and angioplasty procedures. The researchers also showed that patients receiving this drug were more likely to achieve optimal blood thinning levels.
The Mayo Clinic team has developed a consensus statement recommending the use of pamidronate over zoledronic acid for starting therapy, and stopping or reducing bisphosphonates after two years for safe management of multiple myeloma. The guidelines aim to minimize adverse reactions while maintaining effective bone disease prevention.
A study published in the Proceedings of the National Academy of Sciences found that galantamine, an Alzheimer's medication, can effectively counteract the toxic effects of nerve agents and certain insecticides. The treatment was shown to protect the brain from organophosphorus compounds, even when administered after exposure.
A University of Georgia study found that three-quarters of people prescribed antidepressant drugs receive the medications for a reason not approved by the federal Food and Drug Administration. The researchers called for greater emphasis on evidence-based medicine to ensure greater safety in off-label prescribing.
A recent study found that prescription painkillers, such as oxycodone and hydrocodone, are involved in more drug overdose deaths than cocaine or heroin in the US. Overdose deaths from these drugs have increased significantly over the past 15 years, with sales of opioid painkillers rising parallel to deaths.
A large-scale study found that two-thirds of patients stopped using Uprima due to ineffectiveness, with 70% of family doctors agreeing. The study analyzed data from 11,185 patients and showed that the most common adverse reactions were headache and nausea.
The number of outpatient health care visits for antipsychotic medications among children and adolescents in the US increased six-fold between 1993 and 2002. Diagnoses included disruptive behavior disorder, mood disorders, and psychotic disorders. Further research is needed to confirm safety and efficacy.
A Stanford scientist's study reveals that 21% of prescriptions dispensed in 2001 were for conditions with little or no FDA-approved evidence, and 73% had no scientific backing. This practice, known as off-label prescribing, carries unknown risks and lacks rigorous scrutiny.
The proposed approach would feature conditional approval followed by postmarketing studies required before condition removal. The FDA needs increased ability to regulate drugs after marketing with more resources for postmarketing safety studies.
Authors debate the benefits and harms of direct-to-consumer advertising of prescription drugs. Some argue it can promote underused, life-saving medications, while others claim it raises patients' expectations, increases the quality of care, but also delivers flawed information that may lead to premature adoption of new drugs.
Several serious adverse effects have been identified from analyzing medical insurance claims data. Researchers will present a case study on bisphosphonates and osteonecrosis using dental claims data for enhanced drug safety surveillance.
The conference focused on idiosyncratic DILI, a rare form of liver damage caused by genetic and non-genetic factors. Researchers aim to develop diagnostic tools to identify patients at risk, with studies examining DNA, lymphocytes, and serum samples from patients who have experienced and recovered from idiosyncratic DILI.
The study found that all 55 percent of plastic surgery patients using herbal supplements took at least two different supplements daily, posing bleeding, respiratory, and immunosuppression risks. Patients should inform doctors about natural supplements to ensure safe discontinuation periods and smooth recoveries.
A new report finds that the drug meloxicam is safe for vultures and effective in treating livestock, providing a potential solution to combat diclofenac's devastating effects on vulture populations. The three endangered species of Asian vultures are critically close to extinction due to diclofenac use.
Despite extensive research and calls for reform, US hospitals' patient safety systems have made only modest progress. The study found that while some areas, like surgery, have implemented effective safety measures, others, such as medication management, have seen improvements but are already at high baseline levels.
The Institute for OneWorld Health has received a multimillion-dollar grant from the Gates Foundation to combat VL, a fatal disease transmitted by sand flies. The grant will support a long-term control program, including Phase 4 demonstration studies and clinical trials in children.
A study found that doctors frequently prescribe high-risk drugs despite warning labels, with noncompliance rates ranging from 12.8% to 49.6%. The authors recommend improving warning clarity, patient education, and system support to enhance adherence to recommended practices.
The available evidence on Herceptin for early breast cancer is insufficient to make reliable judgments, states The Lancet. Drug regulatory agencies must consider the totality of available evidence and be free from external influences.
Researchers found that statin drugs can reverse learning deficits in mice with Neurofibromatosis type 1 (NF1), a condition affecting five percent of the world population. The treatment enables normal brain cell communication, creating physical changes in the brain and improving memory.
Experts from Group Health Research Institute outline five principles for making informed decisions on drug coverage, prioritizing true experiments, real health outcomes, and full ranges of alternatives. These evidence-based guidelines aim to protect patients and promote cost-effectiveness.
Five high-profile medical whistleblowers share their accounts of practices in medicine and research that risk public health and safety. They reveal the 'pharma-FDA complex' may compromise drug development, prescribing, and safety monitoring, leading to potential disasters like Vioxx.
The report has had a positive impact on improving patient safety by changing healthcare views, enlisting support from stakeholders, and altering practices. Clinical effectiveness of safe practices implemented in hospitals show promising results, including reduced medical errors, adverse drug events, and cardiac arrests.
The Canadian Medical Association Journal reports that prescription drug costs have surpassed $18 billion. This significant increase underscores the importance of disseminating unbiased information to ensure patient safety and healthcare sustainability.
A study examining nearly 100,000 patients found that nearly half did not receive recommended laboratory tests to monitor potential drug side effects. The researchers conclude that lapses in drug safety monitoring are common and further research is needed to determine the extent of its impact on actual medical problems.
Researchers have confirmed that methotrexate and leflunomide are safe and effective treatments for children with severe juvenile rheumatoid arthritis. The study found a higher response rate in children compared to adults, providing new hope for families affected by this chronic disease.
A new study published in the Journal of the American College of Cardiology shows that drug eluting stents are just as effective and safe for women as they are for men. However, female patients experience higher re-intervention rates due to smaller vessels and perceived narrower narrowing.
A recent study published in the Archives of Internal Medicine found that medication errors are a significant issue in hospitalized patients. The study examined 151 patients who took at least four prescription medicines at home and had unplanned hospital admissions, revealing that 53.6% had at least one unintended medication discrepancy.
A study of 294 injection drug users found that those who had injected for over two years were two and a half times more likely to access syringes from safe sources. Safe injection and disposal practices were not associated with HIV, hepatitis C, or syringe sharing.
Researchers examine the 75-year history of hormone therapy, including the Women's Health Initiative study that found increased risks of breast cancer, dementia, and heart attacks in women taking combination hormone therapy. The authors argue that conflicting interests between women, physicians, and drug companies have contributed to th...
A cardiologist will testify at an FDA hearing on the implications of animal tests in approving COX-2 inhibitors like Vioxx. The report reveals that these drugs had a heart-protective effect in mice and other animals, contrary to their human performance.
A recent study found that Vioxx increases the risk of coronary heart disease by 34%, with a higher risk associated with standard and high doses. The study estimated that 88,000-140,000 excess cases of serious coronary heart disease occurred in the US due to Vioxx use.
The author highlights the need for more trials to assess cardiovascular risks of COX-2 inhibitors in clinical settings. The FDA's authority is crucial in ensuring the safety profile of prescription medicines and restoring public trust.
A study of 401 US pharmacists found that they are concerned about the safety and quality of imported prescription medications. Pharmacists generally favored regulatory actions to decrease counterfeiting and believed that US pharmacy oversight could mitigate safety risks if importation is allowed.
A study examined the association between cerivastatin sodium and rhabdomyolysis to illustrate the US postmarketing safety-surveillance system's limitations. The authors suggest an outside group should review label changes, new studies, or suspension of sales to balance patient and industry interests.
The US postmarketing surveillance system requires major restructuring to effectively monitor drug safety. An independent agency would oversee the process, ensuring complete independence from pharmaceutical industry influence.
Researchers found that current use of all acid-suppressive drugs was associated with a 27% increase in the risk of pneumonia, particularly among those using proton pump inhibitors or H2-receptor antagonist drugs. The study highlights the need for rational prescribing practices to minimize potential complications.
The article discusses the importance of rigorous data collection and review in drug development, citing the Vioxx case as a prime example. Pharmaceutical companies must also learn from their mistakes, and regulatory agencies must reassess safety and efficacy thresholds to prevent patient harm.
A new study highlights the long-term efficacy and safety of the angina drug nifedipine GITS, showing it can be used safely for the treatment of patients with coronary disease. The trial found similar mortality rates among those receiving the medication and a placebo, but lower incidence of heart failure and coronary interventions.
A review found no reliable scientific evidence supports the use of C. aurantium for weight loss, and high doses may not be safe. The herb interacts with drugs in a manner similar to grapefruit juice, increasing blood levels and potential side effects.
A Northwestern Memorial Hospital study demonstrates that medication reconciliation reduces patient harm and is cost-effective. Pharmacists play a critical role in reconciling medication discrepancies, which can occur during patient transfers or discharge.
Studies suggest that over-the-counter 'Plan B' emergency contraception may lead to increased risk-taking behaviors and reduced comprehensive healthcare access for US women. The drug has an 11-25% failure rate, resulting in additional pregnancies and abortions.
Rosuvastatin, marketed as Crestor, has been linked to a higher incidence of rhabdomyolysis and renal insufficiency compared to other statins. The drug's manufacturer, AstraZeneca, is estimated to be seeking $20 billion in annual sales, making it morally unjustifiable to keep the drug on the market.
A one-year study involving 539 adolescents aged 12 to 16 found that Xenical significantly reduced fat mass, waist circumference, and BMI compared to lifestyle changes alone. The medication was well-tolerated, with similar adverse events reported as in adults.
The guidelines provide a rigorous analysis of the safety, efficacy, and mode of use of new antiepileptic drugs, offering clinicians evidence-based assessments for treatment decisions. The guidelines address concerns about side effects and liver metabolism, providing guidance on using newer drugs safely and effectively.