Changes in procedural antithrombotic strategy are associated with a significant temporal reduction in major bleeding over time in patients undergoing elective post-percutaneous intervention, according to a study published in the Journal of the American College of Cardiology.
New molecular entity: FDA approved lucinactant (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of RDS.
FDA recently issued a warning about an increased risk of developing new cancers for patients taking lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma.
Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)
Recent FDA action (through May 2012) related to, Loxapine, Adasuve, Alexza Pharmaceuticals, Denosumab, Xgeva, Amgen, Furiex, Takeda, Nesina, alogliptin, fixed-dose combination alogliptin and pioglitazone, Liovel, Emtricitabine and tenofovir disoproxil fumarate, Truvada, Gilead Sciences, Lorcaserin, Arena Pharmaceuticals, Eisai, Tofacitinib, Pfizer, Tafamidis, ACH-3102, Achillion, CK-2017357, Cytokinetics, Taliglucerase alfa, Elelyso, Pfizer, Carisbamate, SK Biopharmaceuticals, Vancomycin hydrochloride, Vancocin, Akorn, Watson
On May 15, 2012, FDA announced completion of their safety review of fingolimod (Gilenya, Novartis).
As FDA considers a new paradigm that would expand the definition of nonprescription drugs, healthcare experts say the proposed paradigm could have its benefits and challenges for the healthcare industry.
A look at liposomal bupivacaine, a local anesthetic providing pain relief post-surgery
New molecular entity: FDA approved the synthetic, pegylated erythropoiesis-stimulating agent (ESA) peginesatide (Omontys, Affymax) for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
The drive for personalized medicine and greater patient involvement in treatment decisions demands more informative data on the effects and risks associated with drugs and medical products.
Chronic kidney disease (CKD) remains a significant cause of morbidity and mortality. Here's a review of treatment options and guidelines to delay disease progression.
The use of benzocaine gels and liquids to soothe teething and mouth and gum pain can lead to a rare but serious?and sometimes fatal?condition called methemoglobinemia, according to an FDA Consumer Update.
The drug-shortage crisis got a step closer to being alleviated Thursday, when the U.S. Senate passed FDA?s Safety and Innovation Act (SB-3187).
The use of atypical antipsychotics in patients with major depressive disorder who have not responded to antidepressant therapy substantially increased clinical response rates at 6 weeks; however the drugs are also much more costly, according to the results of an analysis published in the May issue of The Annals of Pharmacotherapy.
The multiple sclerosis drug fingolimod (Gilenya, Novartis) is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or who are taking certain antiarrhythmic medications, according to FDA
Taking probiotics during a course of antibiotics reduces the risk of antibiotic-associated diarrhea, according to the results of a study published May 9 in the Journal of the American Medical Association.
The Affordable Care Act saved Medicare recipients more than $3 billion on prescription drugs and 12.1 million recipients used a free preventive service in the first four months of 2012, the government said in a news release today
FDA has notified healthcare professionals that it is aware of a study published in the New England Journal of Medicine reporting a small increase in cardiovascular deaths and in the risk of death from any cause in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug.
Warfarin fared no better than aspirin at reducing the combined risk of brain hemorrhage, stroke, or death for heart-failure patients in normal rhythm, according to the results of a study published in the New England Journal of Medicine.
A unique study designed to gauge the impact of polypharmacy on schizophrenia mortality produced some surprising results: The use of antidepressants or 2 or more antipsychotics was not associated with increased deaths, but the use of benzodiazepine was.
Patients with schizophrenia who switched from haloperidol decanoate or fluphenazine decanoate to risperidone microspheres discontinued their treatment more frequently, according to a new study published in the March issue of the Journal of Clinical Psychiatry.
Researchers from the University of Washington have identified a threshold concentration of serum 25-hydroxyvitamin D [25-(OH)D] that is associated with increased risk for major medical events and they say that season-specific targets may be more appropriate than static targets when evaluating health risk.
FDA has approved generic versions of clopidogrel tablets USP (Plavix, Sanofi and Bristol-Myers Squibb), 75 mg and 300 mg.
Hospira is voluntarily recalling one lot of hydromorphone injection, USP, 1 mg/mL (C-II), 1-mL fill in 2.5-mL Carpuject, NDC 0409-1283-31, after complaints that a single Carpuject contained more than the 1-mL labeled fill volume, according to a press release posted on the FDA website.
Pharmacists need additional guidance on the handling of biosimilar products in the pharmacy when these products become more widely available following the approval of the biosimilar pathway, said Marcie Bough, senior director of government affairs, APhA, speaking at an FDA hearing last week.
FDA?s Antiviral Drugs Advisory Committee has recommended approval of once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences) to reduce the risk of HIV-1 infection among uninfected adults.
