An Endocrine Society task force has established new clinical-practice guidelines that recommend screening adults for high triglyceride levels once every 5 years because of the potential risk of cardiovascular disease and pancreatitis associated with hypertriglyceridemia.
FDA is supporting antibacterial drug development by launching a new internal task force, according to a press release today.
FDA has given priority review to an additional indication for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
Watson Laboratories issued a voluntary nationwide recall for 2 lots of hydrocodone bitartrate and APAP Tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.
FDA has approved aflibercept (Eylea, Regeneron) injection for the treatment of macular edema following central retinal vein occlusion (CRVO). The recommended dose for Eylea is 2 mg every 4 weeks (monthly).
FDA approved a new indication for denosumab (Prolia, Amgen) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.
Biologic response modifiers developed for the treatment of rheumatoid arthritis do not appear to be associated with an increased risk of cancer, according to a study published September 5 in the Journal of the American Medical Association.
Children with asthma who use glucocorticoid inhalers may grow shorter on average than those who do not use inhaled corticosteroids (ICS), according to a study published September 6 in the New England Journal of Medicine.
The risks of end stage renal disease, chronic kidney disease, and sustained doubling of serum creatinine concentration are significantly higher in people with at least 1 symptomatic kidney stone episode, according to the results of a study published August 30 in the British Medical Journal.
FDA notified healthcare professional about a possible increased failure of heart risk with pramipexole (Mirapex).
FDA has granted fast-track designation for the development of AVI-7288 and AVI-7537 (Sarepta Therapeutics), for the treatment of Marburg virus and Ebola virus, respectively.
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.
