The FDA approved Dalvance (dalbavancin), an intravenous antibacterial for adults with acute bacterial skin and skin structure infections, including MRSA. In two trials totaling 1,289 adults it matched vancomycin. It is the first Qualified Infectious Disease Product approved.
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Drug
Prescription drugs, vaccines and their risks and benefits.
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Drug
Hepatitis B Vaccine Approved
FDA approved Merck's supplement to its biologics license for the Recombivax HB hepatitis B vaccine made at West Point, Pennsylvania, covering package insert changes that bring the labeling format into line with the Physician's Labeling Rule.
Drug
FDA Updates for Health Professionals
An FDA MedWatch roundup for clinicians: Hospira recalls one lot of Labetalol Hydrochloride Injection over visible particulates in the vial, CareFusion recalls Alaris Pump software that fails to delay infusions properly, and Ventlab removes resuscitator bags whose duckbill valves can stick.
Drug
Antisense oligonucleotide (OL-1) may cure Alzheimer's disease?
In a Journal of Alzheimer's Disease study, genetically modified mice prone to forming amyloid beta protein and treated with the antisense compound OL-1 showed learning and memory matching wild mice. The compound blocks translation of the amyloid beta precursor gene.
Drug
Update of CVM's What's New - Get the Facts about Pain Relievers for Pets
FDA's veterinary center warns owners not to raid the medicine cabinet when a dog limps. Human NSAIDs such as aspirin, ibuprofen and naproxen, or a drug left over from another pet, may not suit the animal and could hurt it, so call the veterinarian first.
Drug
A drug used to treat idiopathic pulmonary fibrosis found ineffective
The NIH-supported PANTHER-IPF trial found N-acetylcysteine no better than placebo for patients with mild to moderate idiopathic pulmonary fibrosis. Over 60 weeks of follow-up, researchers saw no significant difference in lung function decline, flare-ups, deaths or hospitalizations.
Drug
FDA requiring lower starting dose for sleep drug Lunesta
The FDA is requiring Lunesta's maker to cut the recommended starting dose from 2 mg to 1 mg for both men and women, after data showed eszopiclone levels can stay high enough the next morning to impair driving even in patients who feel fully awake.
Drug
Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin
An FDA study of more than 134,000 Medicare patients found Pradaxa was associated with lower risks of clot-related stroke, brain bleeding and death than warfarin, but a higher risk of major gastrointestinal bleeding. The agency changed no labels and says patients should not stop on their own.
Drug
How Long Should You Take Certain Osteoporosis Drugs?
An FDA review published in the New England Journal of Medicine found some osteoporosis patients may be able to stop taking bisphosphonates after three to five years and still benefit. The authors say more research is needed on fracture risk after stopping and on restarting.
Drug
New cancer immunotherapy could be effective against a range of cancers
NCI scientists report in Science that the immune system can mount a response against mutant proteins made by epithelial cancers, which include tumors of the digestive tract, lung, pancreas and bladder. Steven Rosenberg calls the method a blueprint for attacking a patient's own mutations.
Drug
New Tool Helps Women Assess Risk for Hereditary Breast and Ovarian Cancers
The CDC points women to a new tool, Know:BRCA, that explains the BRCA1 and BRCA2 genes and helps assess the chance of carrying a mutation that raises breast and ovarian cancer risk. About 9,000 US women under 40 are diagnosed with breast cancer each year.
Drug
FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients
FDA approved Zontivity (vorapaxar), the first PAR-1 antagonist, to reduce heart attack, stroke and cardiovascular death in patients with a prior heart attack or leg-artery blockages. Risk fell from 9.5% to 7.9% over three years in the supporting study; bleeding carries a boxed warning.
Drug
Can an aspirin a day help you ward off a heart attack or stroke?
FDA's Robert Temple says a daily low-dose aspirin can help people who have already had a heart attack or stroke avoid another, but FDA found the data do not support taking it for primary prevention, where bleeding risks remain. Talk to a clinician first.
Drug
FDA: No more than than 325 mg of acetaminophen should be used
FDA reminds prescribers and pharmacists to stop dispensing prescription combination products containing more than 325 mg of acetaminophen per dosage unit. Manufacturers withdrew them at FDA's request over the risk of severe liver damage, and wholesalers are asked to return remaining stock.
Drug
Some antibiotics riskier than others
In a study of US veterans in Annals of Family Medicine, patients given azithromycin were 48% more likely to die and 77% more likely to suffer serious arrhythmia during days 1 to 5 than those on amoxicillin. Levofloxacin carried raised risk across the full 10 days.
Drug
Medtronic Agrees to Settle Certain INFUSE® Bone Graft Product Liability Cases
Medtronic agreed to pay about $22 million to resolve an estimated 950 filed and unfiled INFUSE Bone Graft claims, calling the deal no admission of liability. Roughly 750 cases remain pending, and the company expects a charge of $120-$140 million.
Drug
Can an aspirin a day help you ward off a heart attack or stroke?
FDA's Robert Temple says a daily low-dose aspirin can help people who have already had a heart attack or stroke avoid another, but the agency concluded the data do not support it for people who have never had cardiovascular problems, who still face bleeding risks.
Drug
cobas® HPV Test - P100020/S008 from FDA
The FDA approved Roche's cobas HPV Test as the first HPV test for primary cervical cancer screening. It finds DNA from 14 high-risk types, singling out HPV 16 and 18, and may be used in women 25 and older alongside screening history and other risk factors.
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