Drug Safety - Fluoroquinolone use was associated with a statistically significant 85% increase in the risk for arrhythmia and 71% increase in the risk for cardiovascular mortality. Moxifloxacin ranked with the highest probability for cardiovascular adverse events. Read More →
Read MoreFDA - approved INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular (CV) events, including heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes (T2D) who have established CV disease. INVOKANA® is the first and only oral diabetes treatment approved with this indication. Read More →
Read MoreJAMA - This prespecified analysis found no evidence to support guideline recommendations that encourage initiation of treatment in patients with low-risk mild hypertension (untreated blood pressure of 140/90-159/99 mm Hg). There was evidence of an increased risk of adverse events, which suggests that physicians should exercise caution when following guidelines that generalize findings from trials conducted in high-risk individuals to those at lower risk. Read More →
Read MoreAGA – released guideline on medical management of opioid-induced constipation (OIC) which included recommending laxatives as first-line agents, recommending PAMORAs naldemedine, naloxegol, and methylnatrexone over no treatment, and making no recommendation for the use of lubiprostone or prucalopride. Read More →
Read MoreFDA - approved new indication for Dupixent® (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. It is the only asthma biologic that offers patient self-administration at home. Dupixent comes in two doses (200 mg and 300 mg) given every other week at different injection sites after an initial loading dose. Read More →
Read MoreFDA - approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. Read More →
Read MoreFDA – approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus. BIJUVA is expected to be available in pharmacies in the second quarter of 2019. Read More →
Read MoreFDA – approved the biosimilar, Hyrimoz (adalimumab-adaz) for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn's disease (CD), ulcerative colitis (UC) and plaque psoriasis (Ps). Read More →
Read MoreJAMA - Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement, weight loss, or muscle building. The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements, and synthetic steroids or steroid-like ingredients for muscle building supplements. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects. Read More →
Read MoreFDA announced recalls of multiple lots of ScieGen Pharmaceuticals’ Irbesartan Tablets 75mg, 150mg, and 300mg labeled as Westminster Pharmaceuticals and Golden State Medical Supply due to impurity; one lot of Promise Pharmacy’s Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile 3mL vials (small particulate in solution). Read More →
Read MoreIn a high-risk population of overweight or obese patients, lorcaserin facilitated sustained weight loss without a higher rate of major cardiovascular events than that with placebo. Read More →
Read MoreREDUCE-IT study met its primary endpoint demonstrating an approximately 25% relative risk reduction in major adverse CV events (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo. Patients enrolled had LDL-C between 41-100 mg/dL controlled by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides (TGs) between 150-499 mg/dL and either established cardiovascular disease or diabetes mellitus and at least one other CV risk factor. Read More →
Read MoreAs compared with the placebo group, women with osteopenia who received zoledronate had a significantly lower risk of nonvertebral fragility fractures, symptomatic fractures, vertebral fractures, and height loss. The number of women that would need to be treated to prevent the occurrence of a fracture in 1 woman was 15. Read More →
Read MoreAmong nonpregnant adults with subclinical hypothyroidism, the use of thyroid hormone therapy was not associated with improvements in general quality of life or thyroid-related symptoms. These findings do not support the routine use of thyroid hormone therapy in adults with subclinical hypothyroidism. Read More →
Read MoreIn patients with type 2 diabetes and cardiovascular disease, albiglutide (Tanzeum) was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Read More →
Read MoreIn the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 trial, FARXIGA achieved a statistically-significant reduction in the composite endpoint of hospitalization for heart failure or CV death. Read More →
Read MoreBetween 2006 and 2015, a high‐risk anticholinergic prescription was listed in 6.2% of office-based physician visits of older adults. The most common drug classes were antidepressants, antimuscarinics, and antihistamines. Quality prescribing should be promoted because safer alternatives are available. Read More →
Read MoreAdamis – FDA has approved Adamis’ lower dose version (0.15mg) of Symjepi ™ for the emergency treatment of allergic reactions (Type I) including anaphylaxis. This lower dose version is intended to potentially treat patients weighing 33-66 pounds. Read More →
Read MoreNovartis – FDA has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair® (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. The new Xolair PFS formulation is expected to be available by the end of this year for the first time in the US. Read More →
Read MoreEli Lilly – FDA has approved Emgality™ (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults. Emgality offers a once-monthly, self-administered, subcutaneous injection. Patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program. Read More →
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