In mid-December, FDA reported that dronedarone (Multaq) increased the risk of serious cardiovascular events, including death, when used in patients with permanent atrial fibrillation (AF), according to its safety drug communication.
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FDA approved ivacaftor (Kalydeco, Vertex Pharmaceuticals) for the treatment of a rare form of cystic fibrosis in patients aged 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator gene.
FDA approved ingenol mebutate (Picato, LEO Pharma) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK). It is the first topical AK therapy that can be used for as few as 2 or 3 consecutive days.
FDA recently announced that a clinical trial evaluating the effects of doripenem (Doribax, Janssen) on the treatment of patients with ventilator-associated pneumonia was halted because of an increase in death rate and a poor clinical cure rate.
FDA and Seattle Genetics, which makes brentuximab vedotin (Adcetris), have updated the warning label on the company’s cancer drug after a second patient developed progressive multifocal leukoencephalopathy.
Aspirin prophylaxis in people without prior cardiovascular disease does not appear to reduce cardiovascular death or cancer mortality, according to the results of a meta-analysis published online January 9 in the Archives of Internal Medicine.
Older women who use statins may be at an increased risk for diabetes mellitus, according to the results of a study published online January 9, in the Archives of Internal Medicine.
Approximately 1 in 100 patients undergoing total or partial knee replacement surgery and 1 in 200 patients undergoing total or partial hip replacement surgery will experience a venous thromboembolism event, including deep vein thrombosis and pulmonary embolism, before being discharged from the hospital, according to a new study.
The Endocrine Society recently released new clinical practice guidelines recommending that all patients have their blood-glucose levels tested upon admission to the hospital, even if they haven’t been diagnosed with diabetes.
Indian drug giant Ranbaxy has accepted a consent decree filed by the U.S. Department of Justice on behalf of FDA. The decree, which must still be accepted by the U.S. District Court for the District of Maryland, requires Ranbaxy to fix long-standing manufacturing problems at plants in India as well as a plant in the United States.
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The results of a long-term follow-up of chlorthalidone stepped-care therapy for isolated systolic hypertension demonstrated that the treatment is associated with a longer life expectancy.
Individuals who are able to maintain or decrease their blood pressure (BP) to normal levels during middle age have the lowest lifetime risk for cardiovascular disease. In contrast, individuals who experience an increase in BP have higher lifetime risks, according to a study published in Circulation.
FDA announced in late December that McNeil Consumer Healthcare Division of McNeil is voluntarily recalling certain lots of Motrin IB 24-count coated caplets, Motrin IB 24-count coated tablets, and Motrin IB 24+6-count coated caplets from retailers.
In a safety announcement, FDA notified the public that that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores.
Antithrombotics
New drugs to treat chronic obstructive pulmonary disease (COPD) have increased treatment options. However, they have also caused health plans to re-evaluate their chronic-condition management strategies.
Paying for performance will cause many health plans to rethink how they contract with provider networks, and experts say there are tremendous changes ahead.
Recent FDA Approvals (through December 2011) related to (Antares, Isentress, REMS)
New indication: Tadalafil once-daily 5-mg oral tablet is FDA approved for the treatment of benign prostatic hyperplasia (BPH) in patients with or without erectile dysfunction (ED).
New indication: FDA approved rivaroxaban once-daily oral tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular AF.
Election-year politics will color a range of legislative and policy developments affecting drug development, production, and reimbursement in the coming year, as efforts to reduce government spending on healthcare prompts all parties to search for opportunities to do more with less. Looming over the political landscape is the upcoming Supreme Court decision on the constitutionality of the Obama health reform legislation.
New molecular entities (NMEs) for calendar year 2011 number 30, considerably above the average of 23 during the past 10 years. Notably among this list are 8 drugs for cancer; 10 targeting orphan diseases; 2 each for hepatitis C and chronic obstructive pulmonary disease (COPD); and 3 anticoagulants.
The oral anticoagulant rivaroxaban lowered the risk of death, heart attack, and stroke in acute coronary syndrome (ACS) patients, according to a study presented at the American Heart Association's Scientific Sessions 2011 in Orlando, Fla., in mid-November.
Even though a new study did not show a correlation between pharmacist intervention and hospitalization and death rates for heart failure patients, the Heart Failure and Optimal Outcomes from Pharmacy Study (HOOPS) is an important study.
Recent FDA action (through December 2011) related to staccato loxapine, axitinib, mydicar, kalydeco, riboflavin ophthalmic solution, minocycline hydrochloride
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