A draft bill that hopes to address regulatory gaps in oversight of pharmaceutical compounding would give the FDA authority to regulate compounding manufacturers that make sterile products without, or in advance of, a prescription and sell them across state lines, according to a statement by the Senate Health, Education, Labor, and Pensions (HELP) Committee.
FDA has issued a Drug Safety Communication indicating that the drug tolvaptan (Samsca, Otsuka American Pharmaceuticals), used in the treatment of electrolyte disturbances, can cause irreversible liver injury with the potential to result in liver transplant or death.
FDA issued a warning April 26 that the anti-seizure drug, ezogabine (Potiga) may cause pigment changes in the retina as well as blue skin discoloration. It is not known if the changes are permanent, according to an FDA drug safety communication.
10 Things You Need To Know About ICD-10:ICD-10 presents payers with an opportunity to deliver more profitable and innovative care
The US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has halted a phase 2b clinical trial, HVTN 505, evaluating a sequential regimen of 2 HIV vaccine candidates.
Actavis will be able to sell defined quantities of a generic version or an authorized generic version of reformulated OxyContin as early as next year, according to a prepared statement from Purdue Pharma L.P., the manufacturer of the opioid analgesic
Patients who fail to fill a new prescription for statin therapy have a number of reasons, including negative perceptions about the medication, a preference for lifestyle modifications, concerns about side effects, drug interactions, polypharmacy, and a perception that they do not need the drug, according to a study published by The American Journal of Managed Care.
L-carnitine significantly improves cardiac health in patients after a heart attack, according to a multicenter team of investigators in a study published in Mayo Clinic Proceedings.
Global progress has been made since the introduction of pneumococcal conjugate vaccines (PCVs) 13 years ago, according to a report published in the April 26 Morbidity and Mortality Weekly Report (MMWR).
FDA approved a new fixed-dose combination ophthalmic suspension of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%), which is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
FDA has approved a supplemental new drug application (sNDA) for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda Pharmaceuticals) 24 ?g twice daily as the first oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain.
There should be more mental healthcare service delivered in schools to provide comprehensive assessments, early interventions, and treatment
Federal law does not allow generic pharma companies to deviate from brand formula.
As hospitalizations rise, hospital deaths are on the decline.
As FDA takes an increased interest in the prescribing of narcotic medications, due to higher levels of prescribing and increased overdoses over the recent years, the American Society of Health-System Pharmacists (ASHP) stressed the importance of understanding the causes of pain and issues of patient access to appropriate drug therapy.
FDA announced April 16 that it will not approve any generic versions of the original OxyContin formulation as the benefits no longer outweigh its risks. The original OxyContin was withdrawn from sale for reasons of safety, as it could be easily misused and abused by crushing and snorting. The original formulation was approved in 1995.
Healthcare providers believe that the pharmaceutical industry could play an important role in helping value-based healthcare providers such as accountable care organizations to deliver better care at lower cost. But pharma companies currently do a poor job of delivering the kind of data needed to accomplish that goal, according to a survey of physicians in value-based delivery models, conducted by Oliver Wyman, a New York-based management consulting firm.
Women at the highest risk for breast cancer benefit the most from preventive drug therapy, including tamoxifen and raloxifene, according to a study, published in the April 16, 2013, issue of the Annals of Internal Medicine.
The increase in utilization of generic drugs is driving costs down, while the increase in specialty pharmacy utilization is driving costs up, according to the 2013 CVS Caremark annual Insights Report.
On April 15, 2013, 2 pharmaceutical compounders recalled their sterile products following an alert issued by FDA.
Thanks to consumer education efforts on heart disease and hypertension, self-reported hypertension and use of antihypertensive medications has increased in the United States according to the Centers for Disease Control and Prevention (CDC).
Medicare is starting to examine RUC recommendations more closely
Guideline-directed medical therapy for heart failure (HF) is highly cost-effective and able to produce significant health gains for individuals with mild to moderate disease, according a study published April 2 in the Journal of the American College of Cardiology.
On April 5, a US District Court judge ruled that the emergency contraception (EC) pill Plan B One-Step must be made available over-the-counter to all girls and women, regardless of their age. This ruling, made by Judge Edward R. Korman, was in response to a 2011 move by Health and Human Services Secretary Kathleen Sebelius.
PCPs must consider the whole patient with type 2 diabetes, not just the blood glucose, noting that patient weight loss, weight maintenance, and exercise are huge challenges
Within current specialty plan designs, 35% of employers surveyed are using tiers, coinsurance and copays
States and counties with a high prevalence of delayed care had a weaker Medicaid infrastructure
he collaboration between Boehringer Ingelheim and Humana is designed to address these needs as healthcare delivery and treatment programs evolve
The College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) recently issued evidence-based guidelines on molecular testing in lung cancer, and support the recommendation that physicians conduct testing in advanced non-small cell lung cancer patients at the time of diagnosis or at the time of recurrence or progression.
The antiarrhythmia drug amiodarone appears to be linked to a higher risk of cancer in men, specifically those who receive higher cumulative defined daily doses within the first year of treatment, according to a retrospective study published online April 8 in Cancer.