A new multinational study confirms the impact of the recently-approved lung cancer medication, crizotinib, on testosterone. The study was published online first in the April 12, 2013, issue of Cancer.
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Prenatal exposure to valproate significantly increased the risk of autism spectrum disorder and childhood autism in the offspring of mothers who took the anti-epileptic agent, according to a study published in the April 24 issue of the Journal of the American Medical Association.
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.
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).
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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.
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).
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.
FDA has approved doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg (Diclegis, Duchesnay) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management, including dietary and lifestyle modifications. These modifications include eating several small meals instead of 3 large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea.
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.
A New York federal judge has struck down the restrictions on levonorgestrel-based emergency contraceptives and ordered the FDA to make the drugs available without a prescription and without point-of-sale or age restrictions within 30 days, according to an April 4th memorandum and order
Physicians would need to prescribe antibiotics to more than 12,000 patients diagnosed with common colds to prevent 1 hospital admission for pneumonia, according to a study published in the March/April issue of the Annals of Family Medicine.
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