FDA warns that the chemotherapy drug docetaxel contains ethanol that may leave patients feeling intoxicated during and after infusion. Labels on all docetaxel products are being revised, and patients should avoid driving or machinery for one to two hours afterward.
Section archive
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Miscellaneous
Other health and consumer news.
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Miscellaneous
FDA adding general warning to testosterone products about potential for venous blood clots
FDA said on June 19, 2014 that it will require a general warning on the labeling of all approved testosterone products about blood clots in the veins, including deep vein thrombosis and pulmonary embolism, after postmarket reports of clots unrelated to polycythemia.
Miscellaneous
WellCare Names Munson Region President: AR, KY, MS, TN
WellCare Health Plans named Kelly Munson region president for Arkansas, Kentucky, Mississippi and Tennessee, with profit and loss responsibility for its Medicaid and Medicare Advantage businesses there. She had been Kentucky state president since August 2013.
Miscellaneous
Sony Recalls VAIO Flip PC Laptops Due to Fire and Burn Hazards
Sony is recalling about 680 VAIO Flip PC laptops, model SVF11N13CXS, because the Panasonic-made lithium-ion battery can overheat and pose fire and burn hazards. Owners can get a repair or a refund.
Miscellaneous
Adults stop anti-rejection drugs after partial stem-cell transplant reverses sickle cell disease
Half the patients in an NIH trial safely stopped immunosuppressant drugs after a modified blood stem-cell transplant for severe sickle cell disease, researchers report in JAMA. The transplant reversed the disease in nearly all patients, with no rejection or graft-versus-host disease.
Miscellaneous
Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter
Bristol-Myers Squibb is recalling six lots of Coumadin for Injection, 5 mg single-use vials, after visible particulate matter turned up in unreleased samples. Injected particles could cause embolization or allergic reactions; no adverse events have been reported.
Miscellaneous
FDA seeks permanent injunction against California pharmaceutical company
At FDA's request, the Justice Department sued Laclede Inc. of Rancho Dominguez, California and its president, seeking a permanent injunction against four unapproved Luvena prebiotic vaginal products. FDA says it has told the company since 2010 that approval is required.
Miscellaneous
WellCare Acquires Certain Assets from Healthfirst New Jersey
WellCare's New Jersey subsidiary completed its purchase of Medicaid assets from Healthfirst Health Plan of New Jersey, covering about 42,000 members expected to move to WellCare's plan. Terms were not disclosed and 2014 benefits will not change.
Miscellaneous
The Lab for These FDA Scientists Is a Computer Screen
At FDA's National Center for Toxicological Research in Jefferson, Arkansas, the Division of Bioinformatics and Biostatistics collects and analyzes existing research data rather than repeating experiments, aiming to answer questions such as how to keep drug use safe.
Miscellaneous
CDER SBIA Webinar on “Overview of FDA’s Proprietary Name Review Process”
A notice for a CDER Small Business and Industry Assistance webinar on FDA's proprietary name review process, covering draft guidance meant to help sponsors develop drug brand names that are not misleading and do not contribute to medication errors.
Miscellaneous
Four-year, $43 million initiative engages broad expertise in study of mystery conditions
NIH awarded grants to six medical centers to join its Undiagnosed Diseases Network, a four-year, $43 million effort to evaluate and investigate patients whose conditions have gone undiagnosed for years. It builds on a pilot program at the NIH Clinical Center.
Miscellaneous
Mammography Update: MQSA National Statistics
FDA's MQSA scorecard lists 8,691 certified mammography facilities and 13,612 accredited units. Among facilities inspected in fiscal 2014, 86.9 percent had no violation and 0.4 percent had a Level 1 violation. Facilities reported 38,813,874 procedures a year.
Miscellaneous
FY2014 PHEP and HPP Funding
HHS awarded more than $840 million for fiscal 2014 to state and local preparedness efforts: $228.5 million through the Hospital Preparedness Program and $611.75 million through Public Health Emergency Preparedness, to sustain response capacity for outbreaks and disasters.
Miscellaneous
ImmunID Announces Agreement with the Singapore Immunology Network (SIgN) to Study Immune Competence
ImmunID agreed to use its ImmunTraCkeR and ImmunIG tests to measure T and B immune repertoire diversity in blood from patients in a clinical trial led by Singapore's SIgN. Both sides say the collaboration should show how immune competence affects health outcomes.
Miscellaneous
FDA outlines expectations for human drug compounders, including registered outsourcing facilities
The FDA issued several compounding policy documents: draft interim guidance on good manufacturing practice for registered outsourcing facilities, a final guidance, two revised requests for bulk drug substance nominations, and a proposed rule adding 25 products to the do-not-compound list.
Miscellaneous
New Healthcare Social Network Connects Users to Best Providers, Treatments and Medications Based on Past Patient Experience
NeedMe Inc. launched a healthcare social network that anonymously links newly diagnosed patients with past patients who had the same conditions, tests and treatments at the same locations. The company says 79% of newly diagnosed people search online for answers.
Miscellaneous
Superbug-Slaying Robot TRU-D Arrives At Covenant and Sartori Medical Centers
Wheaton Franciscan Healthcare-Iowa has deployed TRU-D SmartUVC at Covenant Medical Center in Waterloo and Sartori Medical Center in Cedar Falls. Its Sensor360 technology measures reflected UVC and calculates the dose needed, and cloud software now logs the disinfection data.
Miscellaneous
Ameritox Sponsors Youth Basketball Camps Focused on Drug Abuse Prevention
Ameritox is sponsoring Operation UNITE's “Shoot Hoops, Not Drugs” summer basketball camps in rural Kentucky, which pair skills instruction with drug-abuse prevention. The release says drug-related deaths in the state number more than 100 each month.
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