乌鸦传媒

<乌鸦传媒 class='mpt-top_cat_title'>Washington Watch >

FDA General

<乌鸦传媒>Give Me That Old Time AMA

After an absence of a few years, I find myself back in Chicago for the AMA's annual meeting and discover that not much has changed.

<乌鸦传媒>How To Tell Fake Neck Pain From Real: The Pain Medicine News Report

A regular update on what鈥檚 new in surgery from our friends at Pain Medicine News.

<乌鸦传媒>Medtronic's Infuse Moves From Operating Room to Courtroom

An investigative series by 乌鸦传媒/Milwaukee Journal Sentinel has been tracking the spinal fusion device called Infuse in a 4-year-long series and now reports how a flawed FDA system for device approval may have led to a long string of adverse events culminating in thousands of liability suits.

<乌鸦传媒>FDA Slashes Starting Dose for Lunesta

SILVER SPRING, Md. -- Patients starting on the sleep drug eszopiclone (Lunesta) should take no more than 1 mg at bedtime -- one-third the current label-recommended dose -- because of the risk of next-day impairment, the FDA said Thursday.

<乌鸦传媒>FDA Panel Nixes OTC Singulair

Montelukast (Singulair) should not be allowed over-the-counter use for hay fever and other upper respiratory allergy symptoms, an FDA advisory panel recommended Friday.

<乌鸦传媒>FDA Warns of Cancer Risk With Laparoscopic Device

WASHINGTON -- Hysterectomy and procedures to remove uterine fibroids should avoid use of laparoscopic power morcellation, according to a safety advisory from the Food and Drug Administration.

<乌鸦传媒>FDA Panel Says Yes to Inhaled Insulin Device

HYATTSVILLE, Md. -- An FDA advisory panel has voted in favor of approving a new inhaled insulin device, Afrezza, as a short-acting treatment to improve glycemic control in both type 1 and type 2 diabetes.

<乌鸦传媒>Cologuard Cancer Test Aces FDA Panel Review

WASHINGTON -- An FDA advisory committee unanimously affirmed the safety and efficacy of a DNA stool test for colorectal cancer screening.

<乌鸦传媒>Culture Shock: Homeopathic Recall is No Joke

Did you hear about the homeopathic physician who was treating himself and one day forgot to take his pills?

<乌鸦传媒>CT Appears Safe in Patients With Pacemakers, ICDs

Patients with cardiac rhythm management devices showed no clinically significant major or minor events related to computed tomography imaging over a 10-year period at two large-volume care centers, researchers reported.

<乌鸦传媒>FDA OKs Northera for Hypotension

The FDA has approved droxidopa (Northera) for the treatment of neurogenic orthostatic hypotension, a rare disease that results in a drop in blood pressure when patients try to stand up.

<乌鸦传媒>Droxidopa for OH Slammed by FDA Reviewers

SILVER SPRING, Md. -- Droxidopa (Northera) is getting a second look by an FDA advisory committee for the treatment of orthostatic hypotension stemming from neurological disorders like Parkinson's disease, but an agency review doesn't look promising for approval.

<乌鸦传媒>Killing Pain: Tramadol the 'Safe' Drug of Abuse

Almost 2 decades have passed since the FDA approved tramadol as a 'safe' opioid, but the intervening years provide evidence to question that 'safe' claim, as this latest investigation by John Fauber for the Milwaukee Journal Sentinel-乌鸦传媒 revealed.

<乌鸦传媒>FDA: Nipple Test No Substitute for Mammogram

A nipple aspirate test shouldn't take the place of mammography or otherwise be used on its own to screen for breast disease, the FDA warned.

<乌鸦传媒>Use of Expired Auto-Injectors OK'd by FDA

WASHINGTON -- The FDA cautioned emergency medical staff to retain recently expired auto-injectors by Meridian Medical Technologies and to use them in emergencies if no other product is available.

<乌鸦传媒>FDA Flags Risk of Nuclear Stress Test Drugs

SILVER SPRING, Md. -- Two agents used in cardiac nuclear stress tests may carry a greater risk of heart attack and death than previously believed, the FDA said Wednesday.

<乌鸦传媒>Morning Break: Addictive Oreos and Sperm-Slaying Bacon

Health news and commentary from around the Web, gathered by the 乌鸦传媒 staff.

<乌鸦传媒>FDA Approves Device to Treat Enlarged Prostate

SILVER SPRING, Md. -- An implanted suture-based system to help men with enlarged prostates urinate more freely has been approved by the FDA, the agency said Friday.

<乌鸦传媒>FDA Beefs Up Fluoroquinolone Warning

The risk of nerve damage that fluoroquinolone antibiotics carry may come on rapidly and perhaps be permanent, the FDA warned Thursday.

<乌鸦传媒>FDA Panel Vetoes New Tolvaptan Indication

SILVER SPRING, Md. -- An FDA advisory committee has declined to endorse an expanded indication for tolvaptan (Samsca) to treat autosomal dominant polycystic kidney disease.

<乌鸦传媒>FDA Warns of Fatal Skin Reactions with Acetaminophen

SILVER SPRING, Md. -- Acetaminophen is associated with rare but severe and sometimes fatal skin reactions at usual doses, the FDA said Thursday.

<乌鸦传媒>FDA Panel Favors Nasacort OTC Switch

SILVER SPRING, Md. -- An FDA advisory committee voted Wednesday to make allergy nasal spray triamcinolone acetonide (Nasacort AQ) available without a prescription -- but some expressed concern about its use in children.

<乌鸦传媒>Wyeth Settles Rapamune Marketing Charge

WASHINGTON, D.C. -- Pfizer's Wyeth Pharmaceuticals unit will pay $490.9 million to resolve state and federal allegations that it marketed rapamycin (sirolimus, Rapamune) for unapproved indications.

<乌鸦传媒>New Version of Fibromyalgia Drug OK'd for Depression

The FDA has approved levomilnacipran (Fetzima), a single-enantiomer version of the fibromyalgia drug milnacipran (Savella), for treating major depression, its developers said.

<乌鸦传媒>FDA Goes After Fake Diabetes Therapies

The FDA has sent letters to 15 companies warning them to stop marketing products that falsely claim to treat diabetes, the agency announced.

<乌鸦传媒>FDA Panel Nixes Humira for Spinal Arthritis

SILVER SPRING, Md. -- An independent panel of FDA advisers overwhelmingly rejected AbbVie's bid to gain approval of Humira (adalimumab) for treatment of spinal arthritis.

<乌鸦传媒>FDA Adds GI Warning to Benicar Label

WASHINGTON -- The FDA ordered the maker of the blood pressure drug olmesartan (Benicar) to add a warning about risk of the intestinal condition known as sprue-like enteropathy to the drug's label.

<乌鸦传媒>Xarelto Gets a No for Stent Thrombosis

SILVER SPRING, Md. -- The FDA has rejected an application for a new indication allowing rivaroxaban (Xarelto) to be used to reduce the risk of stent thrombosis in patients with acute coronary syndrome.

<乌鸦传媒>Public Citizen's Wolfe Still Needling FDA

Sidney Wolfe, MD, founder of Public Citizen's Health Research Group, sat down this week with 乌鸦传媒 in his Washington office to discuss his 40 years of work as a leading voice in consumer health advocacy.

<乌鸦传媒>CDC: Cut Back on Doxycycline Use

A continuing shortage of doxycycline means the drug should be used only for conditions that have no alternative treatments, the CDC advised this week.

<乌鸦传媒>Zilver Stent Recalled, System May Break

Cook Medical's Zilver PTX drug-eluting stent for peripheral artery disease has been recalled because of a defect in its associated delivery system, the company and the FDA said.

<乌鸦传媒>FDA Lowers Age for OTC Plan B

WASHINGTON -- The FDA has approved over-the-counter sale of the emergency contraceptive Plan B One-Step to women and girls as young as 15.

<乌鸦传媒>FDA Splits on Safety of Endo's Aveed for Low-T

SILVER SPRING, Md. -- An FDA advisory committee was split Thursday on the safety of an injectable form of testosterone replacement, but voted overwhelmingly against a proposed risk mitigation plan.

<乌鸦传媒>Fatal Reactions Prompt Omontys Recall

All lots of the new anemia drug peginesatide (Omontys) have been recalled because of severe hypersensitivity reactions -- some fatal -- observed after the drug was approved last March.

<乌鸦传媒>Judge OKs $762 Million Deal in Aranesp Case

A federal judge approved a $762 million settlement Wednesday in a case involving Amgen's off-label promotion of darbepoetin alfa (Aranesp), an anemia drug.

<乌鸦传媒>Amgen Agrees to Pay $762 Million in Aranesp Case

The biotech drug giant Amgen pled guilty Monday to promoting its blockbuster anemia drug darbepoetin alfa (Aranesp) for off-label dosing regimens, agreeing to pay $762 million in fines.

<乌鸦传媒>No Need for Skin Preps to Be Sterile, FDA Told

WASHINGTON -- Requiring that antiseptic skin preparation products be sterile is unnecessary and wouldn't lead to a dramatic drop in infections, speakers told the FDA Wednesday.

<乌鸦传媒>FDA Panel Gives Thumbs Down to Opioid

SILVER SPRING, Md. -- An FDA advisory committee voted 11-2 on Friday against recommending approval of a single-entity hydrocodone product, raising questions about its abuse potential.

<乌鸦传媒>High-Dose Zofran Pulled From Market

WASHINGTON -- The 32-mg dose of the anti-nausea drug ondansetron (Zofran) has been pulled from the market because of concerns about cardiac problems, the FDA announced Tuesday.

<乌鸦传媒>Compounder Tied to Tainted Eye Meds, Lost Sight

CHICAGO -- All but one of 12 patients given injections of contaminated bevacizumab (Avastin) prepared by a compounding pharmacy permanently lost vision in the affected eye, researchers reported here.

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