Clinical Pharmacology

Recent FDA action (through August 2012) related to, ferric carboxymaltose injection, Injectafer, abiraterone acetate, Zytiga, cabozantinib, Exelixis, eltrombopag, Promacta, AEZS-130 oral ghrelin agonist, inhaled nitric oxide, GeNO LLC, gevokizumab, XOMA, calcipotriene cream, Dovonex, montelukast sodium, Singulair, lidocaine topical patch 5%, Lidoderm, filgrastim, Neupogen

New molecular entity: FDA approved Mirabegron (Myrbetriq, Astellas Pharma US) for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Irritable bowel syndrome is functional gastrointestinal disorder that is expensive to treat and can impair quality of life. Current therapies are reviewed.

A look at the decision process that lead the Mayo Clinic to abandon the 80-mg dose of simvastatin

A recent study indicates that patients taking statins have a higher risk of developing cataracts.

Recent FDA Approvals (through August 2012) related to (CSL Limited, GlaxoSmithKline Biologicals, ID Biomedical Corp, MedImmune Vaccines, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Genentech, Talon Therapeutics, Amarin, Regeneron Pharmaceuticals, Horizon Pharma, Forest Pharmaceuticals, Onyx Pharmaceuticals, Novartis, Pfizer, Sagent Pharmaceuticals)

New molecular entity: FDA approved Lorcaserin (Belviq, Arena Pharmaceuticals GMBH), as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index deemed obese and the presence of at least 1 weight-related comorbid condition.

A significant number of men who developed persistent sexual side effects from taking finasteride (Propecia and Proscar) also suffer from depressive symptoms and suicidal thoughts, according to a study published online in the Journal of Clinical Psychiatry.

Incretin-based therapies are now the most promising therapies for type 2 diabetes.

Teduglutide is a recombinant analog of human glucagon-like peptide-2 that is awaiting FDA approval for the treatment of short bowel syndrome (SBS) as a once-daily subcutaneous injection.

The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.

New molecular entity: FDA approved taliglucerase alfa (Elelyso, Pfizer), a recombinant active form of the glucocerebrosidase enzyme for long-term enzyme replacement therapy (ERT) for adults with type 1 Gaucher disease.

New formulation: FDA approved pancrelipase delayed-release capsules (Pertyze, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.

The Institute of Medicine reports that a number of issues are causing a number of barriers to successful HIV care in the United States.

Atrial fibrillation(AF) is the most common sustained cardiac arrhythmia and a potent risk factor for stroke. Here's a review of new oral anticoagulants for stroke prevention with AF.

The introduction of the immunomodulatory drugs and bortezomib, a proteasome inhibitor, has dramatically improved outcomes in patients with relapsed or refractory multiple myeloma.

Screening for hepatitis-C may soon become a routine screening for Baby Boomers.

A new study seems to indicate that adding cetuximab to the standard therapy for resected stage 3 colon cancer provides no additional benefits.

Recent FDA action (through July 2012) related to, morphine and oxycodone Dual Opioid platform, MoxDuo, QRxPharma, apixaban, Eliquis, Bristol-Myers Squibb, RG1068, Repligen, Multi-Stem, Athersys, Rivaroxaban, Xarelto, Janssen, Ocriplasmin intravitreal injection, ThromboGenics, Regorafenib, Bayer, Onyx Pharmaceuticals, Pregabalin, Lyrica, Lupin, Diclofenac sodium and misoprostol, Arthrotec, Watson, Next Choice One Dose, Plan B One-Step

The FDA recently announced a safety communication regarding the risk of seizures with MS who are starting dalfampridine.

A recent study from JAMA indicates that most Americans aren't meeting the necessary goals to lower CV risks.

Recent FDA Approvals (through July 2012) related to (Vivus, Gilead Sciences, Orasure, Pfizer, Ferring Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Qiagen, Astellas Pharma US, Roche Molecular Systems, Arena Pharmaceuticals, Eisai)

A review of drug therapies and research presented at the 2012 Scientific Session of the American Diabetes Association.

The results of a recent literature review suggest that only a high intake of vitamin D leads to a significant reduction in the risk of fracture.

FDA has approved once-daily phentermine and topiramate extended-release (Qsymia, Vivus) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 or greater, or 27 or greater in the presence of at least 1 weight-related comorbidity.

FDA recently approved the first over-the-counter test for HIV, providing a confidential in-home testing option for the virus that causes AIDS, with results in as little as 20 minutes.

FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.

Brightly colored prescription warning labels applied by pharmacies fail to adequately capture the attention of older patients, suggesting that current labeling standards should be reconsidered to make them more effective, according to a study published online June 14 in PLoS ONE.

A panel at AMCP's annual meeting discussed the need to improve MS medication adherence.

Recent FDA Approvals (through June 2012) related to (GlaxoSmithKline, XenoPort, Roche)