FDA's Center for Veterinary Medicine conditionally approved PACCAL VET-CA1 in February 2014 for dogs with nonresectable stage III, IV or V mammary carcinoma or with squamous cell carcinoma and no prior chemotherapy or radiotherapy. It is infused intravenously; leakage can cause tissue necrosis.
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Drug
Prescription drugs, vaccines and their risks and benefits.
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Drug
Safe Use of Flea and Tick Products in Pets
FDA veterinarian Ann Stohlman urges pet owners to read the label, package insert and any accompanying literature before using flea and tick pills, collars, sprays, dips, shampoos, powders or spot-ons. FDA and EPA divide regulation of these products between them.
Drug
FDA approves Sivextro to treat skin infections
The FDA approved Sivextro, given intravenously or orally, for adults with acute bacterial skin infections caused by bacteria including MRSA. In two trials of 1,315 adults it worked as well as linezolid. It is the second such antibacterial approval in a month.
Drug
Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication
FDA is alerting patients who had mammograms at Big Sky Diagnostic Imaging in Butte, Mont., after Nov. 19, 2011. A review with the American College of Radiology found poor-quality images; FDA says results were not necessarily wrong but patients should ask about repeat exams.
Drug
FDA approves Sivextro to treat skin infections
The FDA approved Sivextro (tedizolid phosphate) for acute bacterial skin and skin structure infections in adults, including those caused by MRSA. In two trials with 1,315 adults it worked as well as linezolid. It is the second such antibacterial cleared in a month, after Dalvance.
Drug
FDA adding general warning to testosterone products about potential for venous blood clots
FDA is requiring all approved testosterone products to carry a general warning about blood clots in the veins, prompted by postmarket reports of clots unrelated to polycythemia. The agency says this is separate from its continuing review of stroke and heart attack risk.
Drug
Talc in anticancer drugs induce diabetes mellitus
A study in the European Journal of Cancer reports that talc, used as an inactive ingredient in anticancer drugs, promoted diabetes mellitus in rats with hepatocellular carcinoma, raising questions about excipients whose toxicity is not fully known.
Drug
Vioxx Scandal Not Over as Merck returns to Court Over Charges of Bone Harm
Ten years after Vioxx was withdrawn, Merck returns to court against plaintiff Dennis Harrison, who says the drug caused non-healing of spine and bone after surgery. He took it for rheumatoid arthritis, an unapproved use Merck settled misbranding charges over in 2011.
Drug
Mammography screening doesn't lower risk of breast cancer death
Canadian researchers followed 89,835 women aged 40 to 59 for up to 25 years and found annual mammography did not reduce breast cancer deaths: 180 women died in the screening arm and 171 in the control arm. The study appears in the British Medical Journal.
Drug
Hormone treatment restores bone density for yong women with menopause-like condition
An NIH-supported study found hormone replacement therapy raised bone mineral density back to normal in young women with primary ovarian insufficiency, a condition affecting 1 in 100 women by age 40 that leaves them with low estrogen and weakened bones.
Drug
Four Medication Safety Tips for Older Adults
FDA notes that older adults take more medicines and that aging liver, kidney and digestive changes alter how drugs break down and reach the bloodstream, raising the chance of interactions. The first tip: take medicine as prescribed and don't stop without consulting your provider.
Drug
NIH, PCORI announce major award to prevent falls injuries in older people
NIH and PCORI will fund a roughly $30 million, five-year trial of individually tailored strategies to prevent fall injuries in older adults, led from Brigham and Women's, Yale and UCLA across 10 health system sites. First-year funding of $7.6 million was awarded June 1, 2014.
Drug
FDA Approves First Oral Drug for Fleas and Ticks in Dogs with Three Month Duration
The FDA approved Bravecto (fluralaner) chewable tablets, the first oral flea and tick drug for dogs lasting up to 12 weeks. It treats fleas and three tick species for 12 weeks and the lone star tick for 8, and requires a veterinarian's prescription.
Drug
Stopping statins may benefit terminally ill patients
Duke researchers reported at the American Society of Clinical Oncology meeting that stopping statins in patients with advanced cancer and other terminal illnesses improved quality of life and cut costs without raising deaths. Those who stopped lived slightly longer.
Drug
Drug Information Update - New FDA Drug Info: Drug Safety Podcasts
FDA's Division of Drug Information posted new drug safety podcasts for health professionals, including one on an FDA study of more than 134,000 Medicare patients that found lower risks of clot-related stroke, brain bleeding and death with Pradaxa than warfarin, but more major GI bleeding.
Drug
FDA approves first generic versions of celecoxib
Teva may market celecoxib capsules in 50, 100, 200 and 400 mg strengths, with 180-day exclusivity on three of them, and Mylan the 50 mg. As NSAIDs, the capsules carry a boxed warning about heart attack, stroke and serious gastrointestinal bleeding.
Drug
Vascudilators linked to age-related macular degeneration
Among about 5,000 Beaver Dam, Wisconsin residents followed from 1988 to 2013, those taking a vasodilator were 75% more likely to develop early age-related macular degeneration, 19.1% versus 8.2%. Oral beta blocker users had a 71% higher risk of neovascular AMD, the Ophthalmology study reports.
Drug
Lupus Therapies Continue to Evolve (May is National Lupus Awareness Month)
As many as 24,000 Americans are diagnosed with lupus each year. An FDA rheumatologist explains that the autoimmune disease can damage joints, skin, kidneys, heart, lungs and brain, strikes African American women about three times as often as white women, and never fully goes away.
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