FDA expanded the indication for Prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure.
Amneal Pharmaceuticals will start shipping its branded Esomeprazole Strontium 49.3 mg delayed-release capsules on December 18 to three major U.S. wholesalers. Its capsules contain the same active ingredient, esomeprazole, in a different salt form as found in Nexium (esomeprazole magnesium).
US life expectancy for people with cancer hit another all-time high, rising over 50 million life-years (LYS) after diagnosis, according to statistics collected through the Value of Medical Innovation initiative, led by the Center for Medicine in the Public Interest (CMPI).
Manufacturers of antibacterial hand soap and body wash will be required to show that their products are more effective than plain soap and water in preventing illness and the spread of infection, under a FDA-proposed rule.
Individuals diagnosed with rheumatoid arthritis (RA) more recently experienced decreased disability and psychological problems than those treated 20 years ago. While treatment strategies have helped, researchers attribute the positive effects to greater physical activity and encouragement of a worthwhile life by healthcare professionals.
Children hospitalized for pneumonia have similar outcomes, including length of stay and costs, regardless of whether they are treated with “big gun” antibiotics such as ceftriaxone or cefotaxime or more narrowly focused antibiotics such as ampicillin or penicillin, according to a Vanderbilt study published in Pediatrics.
CVS Caremark and Cardinal Health are about to become the single biggest supplier of generic drugs in the United States.
Diabetes was associated with an increased risk for developing hepatocellular carcinoma, a type of liver cancer, and this association was highest for Latinos, followed by Hawaiians, African-Americans, and Japanese-Americans, according to results presented here at the Sixth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Dec. 6-9, in Atlanta.
FDA announced that it had given approval to several pharmaceutical companies to market duloxetine delayed-release capsules (Cymbalta, Eli Lilly), for the treatment of depression and other conditions. in various strengths. Companies named were Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd.
On December 6, FDA approved Sovaldi (sofosbuvir) tablets for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
FDA has approved sofosbuvir (Sovaldi, Gilead) to treat chronic hepatitis C virus (HCV) infection. According to FDA, Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.
A specific type of diabetes drug can decrease the risk of cancer in female patients with type 2 diabetes up to 32%, according to a study published in Diabetes, Obesity and Metabolism. People with type 2 diabetes have a higher rate of cancer development and recurrence compared to the general population.
A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by FDA and published November 25, 2013, in The Proceedings of the National Academy of Sciences, shows that acellular pertussis vaccines licensed by FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated.
In cancer patients with concurrent type 2 diabetes, metformin alone or in combination with other regimens was associated with 34% reduction in overall death risk and 38% reduction in cancer-specific death risk, according to a study in the December issue of The Oncologist.
Taking effervescent, dispersible, and soluble medications that contain sodium long term increase the risk of cardiovascular events, including heart attacks and strokes, according to a study published in the British Medical Journal.
FDA approved a new use for collagenase clostridium histolyticum (Xiaflex, Auxilium Pharmaceuticals) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.
The Centers for Disease Control and Prevention (CDC) with the help of the American Pharmacists Association (APhA) Foundation has developed a tool kit for instituting collaborative practice agreements between healthcare providers and pharmacists, which is intended to improve healthcare quality.
Among primary care patients with uncontrolled hypertension, medication nonadherence was more than twice as common in patients with post-traumatic stress disorder (PTSD) (68%) as compared to patients without PTSD (26%), according to a study reported online in JAMA Internal Medicine.
Patients with diabetes who received prescribed heart medications by mail were less likely to visit the emergency room than those who picked up prescriptions in person, according to a new Kaiser Permanente study published in the American Journal of Managed Care.
Many patients who stopped taking cholesterol-lowering statin drugs were also taking an average of 3 other drugs that interfered with the normal metabolism of statins, according to a study published in the Journal of Clinical Lipidology.
Pregnant women exposed to environmental phthalates are at an elevated risk of preterm delivery, according to a recent study in JAMA Pediatrics.
When Group Health patients received support from a nurse navigator, or advocate, soon after a cancer diagnosis, they had better experiences and fewer problems with their care-particularly in health information, care coordination, and psychological and social care-according to a randomized controlled trial in the Journal of Clinical Oncology.
Data for tiotropium show improved lung function, sustained bronchodilation in patients with moderate asthma severity.
FDA has eased restrictions on patient access to the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). The agency made its determination after an FDA Advisory Committee reviewed the drug in June 2013 and voted to lift its restrictions, and new information was released indicating that the drug carries no heightened cardiovascular risk.
FDA has simeprevir (Olysio, Janssen Therapeutics, Division of Janssen Products, LP) for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.
FDA has expanded the approved uses of sorafenib (Nexavar, Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals) to treat late-stage (metastatic) differentiated thyroid cancer.
