FDA is warning consumers not to use Intestinomicina (Laboratorios Lopez), a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a healthcare provider.
FDA has approved poly-ureaurethane 16% (Nuvail, Innocutis) nail solution to help manage fragile, damaged or brittle nails with cracking or splitting, a condition medically referred to as "nail dystrophy."
Researchers at Weill Cornell Medical College have discovered that an off-patent anti-inflammatory drug kills both replicating and non-replicating drug resistant tuberculosis in the laboratory.
Caffeine may offer promise to patients with Parkinson disease, according to a small study published in Neurology.
Prasugrel may not improve outcomes for patients under the age of 75 years with unstable angina or non-ST-segment elevation myocardial infarction who have not undergone revascularization, according to a study published in the New England Journal of Medicine.
Recommendations for the 2012-2013 influenza season were recently published by the Advisory Committee on Immunization Practices. The recommendations include an updated vaccination schedule for children and information on virus strains, seizures, and egg allergy.
Anticoagulant therapy, particularly the use of aspirin, may reduce the risk of prostate cancer-specific mortality in men treated with radical prostatectomy or radiotherapy for prostate cancer, according to a study published online in the Journal of Clinical Oncology.
There is considerable discrepancy among caregivers and pharmacists regarding the appropriate dosage of acetaminophen for overweight and obese children, according to a recent study published online in the European Journal of Hospital Pharmacy Science and Practice.
FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approving lixivaptan (CRTX 080, Cornerstone Therapeutics), for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.
FDA has approved teriflunomide (Aubagio, Genzyme, a Sanofi company), a once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis.
Qualitest, a subsidiary of Endo Health Solutions, has issued a voluntary, nationwide retail-level recall for 1 lot of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg.
FDA has approved the production and use of Choline C-11 Injection (Mayo Clinic PET Radiochemistry Facility), a PET imaging agent used to help detect recurrent prostate cancer.
Gabapentin may be an effective and well-tolerated treatment for patients with refractory chronic cough, according to a study published August 28 in The Lancet.
A fixed-dose combination of azilsartan medoxomil plus chlorthalidone (Edarbyclor, Takeda) was statistically superior to azilsartan medoxomil coadministered with hydrochlorothiazide at reducing and maintaining systolic blood pressure, according to the results of a phase 3 study published online August 31 in The American Journal of Medicine.
International pharmaceutical companies are increasingly out-sourcing clinical trials to countries in Asia, Latin America, and Eastern Europe, in an attempt to save time, money, and resources, according to a new report from GBI Research.
Retail pharmacies’ smoking cessation programs are effective in helping smokers quit, according to a study published in the September issue of The Annals of Pharmacotherapy.
Early administration of intravenous aspirin, in addition to alteplase, does not improve functional outcome at 3 months for patients with acute ischemic stroke, but increases the risk of symptomatic intracranial hemorrhage, according to a study published online August 25 in The Lancet.
Mepolizumab significantly reduces asthma exacerbations in patients with severe eosinophilic asthma, according to a study published in the August 18 issue of The Lancet.
An FDA advisory panel voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (Novartis) for the management of cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.
FDA has granted priority review to bedaquiline, or TMC207 (Johnson & Johnson's Janssen Research & Development), for treatment of multidrug-resistant tuberculosis.
FDA approved bosutinib (Bosulif, Pfizer) to treat chronic myelogenous leukemia, a blood and bone marrow disease that usually affects older adults.
The Medicare Part D prescription drug program has emerged as the poster child for how private plans can control costs while providing quality care. Even critics of health insurers acknowledge that the drug benefit has been a success.
Drug Watch: Pain
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.
