Clinical Pharmacology

The majority of older women in nursing homes are likely to be deficient in vitamin D during winter months, and those with the lowest levels are at a significantly increased risk of death, according to a study published online February 8, in the Journal of Clinical Endocrinology.

The FDA's Center for Drug Evaluation and Research released a new draft guidance on how it develops and classifies drug-safety issues.

The time from investigational new drug application filing to NDA/BLA approval by FDA of drugs for central nervous system disorders and the subsequent regulatory approval can take 35% longer than other therapeutic categories, according to a recent analysis published in the March/April Tufts Center for the Study of Drug Development Impact Report.

Patients' rheumatoid arthritis symptoms improved after adding prednisone at the start of a methotrexate-based treatment strategy, according to research published in the March 6 issue of the Annals of Internal Medicine.

Postmenopausal women with a higher intake of trans fat have a higher incidence of ischemic stroke, but aspirin may reduce the adverse effects of trans fat, according to a new study.

Veterans of Afghanistan and Iraq with mental health issues, especially post-traumatic stress disorder (PTSD), were more likely to receive high-risk opioids for pain, and those with PTSD were more likely to suffer adverse clinical outcomes, according to a new study.

An experimental diabetes drug, TAK-875, demonstrated its ability to improve blood-sugar control with a low risk of hypoglycemia, according to phase 2 study results published online February 27 in The Lancet.

A mathematical model that uses laboratory values commonly available on admission can help physicians estimate acetaminophen (APAP: N-acetyl-para-aminophenol) overdose amount, time elapsed since overdose, and potential outcome, according to a study published online February 13 in Hepatology.

Antipsychotic medication should be used on elderly dementia patients only in cases of clear need, authors of a recent study said, but they found that some antipsychotics are more dangerous than others after examining data from thousands of nursing-home residents aged 65 or older.

A treat-and-extend regimen of intravitreal bevacizumab (Avastin, Genentech) produced "significant visual improvements" for eyes with neovascular age-related macular degeneration, according to an article published in the March issue of the American Journal of Ophthalmology.

The 2012 Hormone Therapy Position Statement of The North American Menopause Society (NAMS) updates the evidence-based position statement published by NAMS in 2010 regarding recommendations for hormone therapy for postmenopausal women.

New guidelines for the use of the quadrivalent human papillomavirus vaccine, published by the American Academy of Pediatrics, recommend for the first time vaccinating adolescent boys as well as girls.

An FDA advisory panel voted 12-2 to recommend approval of aclidinium bromide (Forest Laboratories and Almirall SA) 400 µg twice daily for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

FDA has approved lucinactant (Surfaxin, Discovery Labs) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Surfaxin is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine.

New indication: Pneumococcal 13-valent conjugate vaccine (Prevnar 13) was granted accelerated FDA marketing approval for the prevention of pneumonia and invasive disease (infection of blood or spinal fluid) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults age 50 years and older.

Warfarin is similar to aspirin in preventing deaths and strokes in patients with heart failure and normal heart rhythm, according to the largest and longest head-to-head comparison study of the 2 anticlotting drugs.

A new analysis of the phase 3 IMPACT study has found that sipuleucil-T (Provenge, Dendreon) increases survival times by an estimated median of 7.8 months in patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer.

Recent FDA Approvals (through February 2012) related to (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)

Minorities are less likely to receive a depression diagnosis and be treated for it than non-Hispanic Whites, according to a new study published on-line and ahead-of-print on December 15, 2011, in the American Journal of Public Health.

The increase in utilization of medications for psychological and behavioral disorders can be attributed to greater awareness among patients that mental health disorders are treatable and that available drug therapies are safe and effective, according to David Muzina, MD, a national practice leader of the Medco Neuroscience Therapeutic Resource Center.

After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

Cost concerns continue to dominate benefit design, resulting in greater cost-sharing from employees, according to survey findings from managed care decision-makers, self-insured employers, and employee benefits consultants.

New molecular entity: FDA approved ruxolitinib, a twice-daily tablet, indicated for the treatment of myelofibrosis.

Second-generation antipsychotics are the mainstay of treatment in schizophrenia.

Every 5 years, Congress is called on to reauthorize a series of user fees that support FDA oversight of drugs and medical products. The Prescription Drug User Fee Act (PDUFA) and similar measures authorizing fees to fund a number of FDA regulatory programs have become increasingly vital for maintaining the agency's ability to maintain an efficient approval process for new therapies.

The 2012 vaccination schedules for children, adolescents, and adults have been released, with changes to the recommendations for meningococcal and human papillomavirus (HPV) vaccinations in children and in hepatitis B vaccinations in adults.

Uncontrolled diabetes may result in hearing loss in women, much like it affects vision or kidney function, according to the results of a new study.

FDA has notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor boceprevir (Victrelis, Merck) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these drugs when they are used together.

The use of proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), according to a recent FDA Drug Safety Communication.

Vorapaxar added to standard of care reduced the risk of cardiovascular events and stroke compared to standard of care alone, according to Merck, who announced top-line results of its TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) study earlier this month. However, results also demonstrated that the drug was associated with a significant increase in bleeding, including intracranial hemorrhage (ICH).