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Washington Watch

FDA Okays Stiolto for COPD

Will include black-box warning about increased risk of asthma-related death.

Three Diabetes Drugs Linked to Ketoacidosis, FDA Warns

FDA targets SGLT2 inhibitors canagliflozin, dapagliflozin, and empagliflozin.

FDA Panel Gets Earful on Homeopathy

Speakers ranged from harsh critics to vocal proponents.

Slippery Slope: Diet Drugs No Help for Heart

In another edition of the Slippery Slope series examining use of surrogate endpoints in drug approvals, 番茄社区 and the Milwaukee Journal Sentinel find diet drugs are approved without solid evidence of benefits, but with hints of harm.

Slippery Slope: $$ in, Diet Drugs Out, How Five Drugs Came to Market

Makers of diet drugs spent more than $60 million on payments to doctors, organized medicine, and lobbyists to get their drugs approved.

SNUS: Is This a 'Safe' Tobacco Product?

Swedish smokeless tobacco maker wants FDA to soften warning label.

Citing Risks, FDA Calls for Label Changes to T Therapy

Agency requires warning on heart attacks, strokes with testosterone replacement.

HDAC Inhibitor OK'd for Multiple Myeloma

Panobinostat targets histone deacetylases; first of its kind to win approval in myeloma.

Cosentyx Gets FDA Nod for Psoriasis

Anti-IL17 drug secukinumab OK'd for moderate-to-severe disease.

FDA Advisers Unimpressed by Nocdurna

Another setback for nocturia indication

FDA Launches Compounding Advisory Committee

The 14 committee members come from a variety of disciplines.

AstraZeneca's Move to Protect Nexium Market Ruled Legal

"Pay to delay" strategy upheld by court.

FDA Panel Wants Safer Epidural Steroid Shots

Majority votes to end epidural injections with "particulate" steroids.

FDA Panel Torn on Watchman Device

Calls the device safe, but splits on its efficacy.

FDA: Black Box Warning on Viscous Lidocaine for Teething

WASHINGTON -- Topical viscous lidocaine should not be used to treat infants' teething pain, the FDA said Thursday, emphasizing that teething pain generally needs no medicinal treatment.

FDA Panel Puts Brakes on Anti-PARP Drug

WASHINGTON -- Approval of a PARP inhibitor for patients with advanced ovarian cancer should await results of an ongoing clinical trial that has the potential to answer questions about the drug's safety and efficacy, according to an FDA advisory committee that voted against immediate approval.

AMA Highlights: VA, Cheerleaders, and Guns

CHICAGO -- Wrapping up a full agenda, the AMA agrees cheerleading is a sport, doctors outside the VA need to pitch in to help care for veterans, and e-cigarettes need to be regulated.

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.

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.

Calif. Docs Among Top Billers for Complex Visits

Three California doctors are among the top five nationally in billing for the most complex office visits, according to data released by Medicare and analyzed by ProPublica and KQED.

Medtronic's Infuse Moves From Operating Room to Courtroom

An investigative series by 番茄社区/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.

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.

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.

Top 5 Reasons Why Internists Are Sued

Not properly diagnosing a condition and nonmedical errors such as equipment failure accounted for more than half of the malpractice lawsuits against internists, a study found.

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.

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.

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.

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?

ICD-10 Follies: Watch Where You're Walking

Yes, there's a code for that. To mark the forthcoming move to the ICD-10 coding system, 番茄社区 is spotlighting some of those thousands of new codes that might just be getting a bit too granular.

5 Ways Doctors Can Use Data Analytics

Data analytics takes claims data, a providers' electronic health record, and any of piece of information available to help physicians become more aware of the patients they're treating. Here are five ways the technology can help meet payers' demands for higher-quality, higher-value care.

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.

ICD-10 Follies: Struck by an Orca

Yes, there's a code for that. To mark the forthcoming move to the ICD-10 coding system, 番茄社区 is spotlighting some of those thousands of new codes that might just be getting a bit too granular.

ICD-10 Follies: The Birds

Yes, there's a code for that. To mark the forthcoming move to the ICD-10 coding system, 番茄社区 is spotlighting some of those thousands of new codes that might just be getting a bit too granular.

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.

5 Problems With Mobile Health App Security

No federal agency has the power to properly regulate the fast-growing world of mobile health applications and telehealth systems, researchers noted while outlining several security risks and privacy threats.

Pay and Practice: Are Neurologists Primary Care Docs?

WASHINGTON -- Neurology isn't often mentioned in the same breath as primary care, but the American Academy of Neurology is again lobbying to gain that sobriquet -- this time to take advantage of a recent policy change that benefits primary care providers.

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.

10 Questions: Rep. Phil Gingrey, MD (R-Ga.)

If you could change one thing about the healthcare system, what would it be? Eliminate Obamacare, says Rep. Phil Gingrey, MD (R-Ga.). That's his answer to just one of the 10 Questions the 番茄社区 staff is asking leading clinicians, researchers, and leaders in their community to get their personal views on their chosen profession. In this series we share their uncensored responses.

'Out of Network': More Money but Some Problems

Whether they plan to or not, a growing number of physicians no longer have contracts with some of the nation's largest health insurance carriers, but being "out of network" has both benefits and drawbacks.

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-番茄社区 revealed.

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