麻豆传媒

Washington Watch

New Drug for ED Wins FDA Approval

WASHINGTON -- The PDE-5 inhibitor class of drugs for erectile dysfunction gained its first new member in a decade with the FDA approval of avanafil (Stendra).

OIG: Avastin a Better Buy for Wet AMD

茂禄驴WASHINGTON -- The Centers for Medicare and Medicaid Services should establish a national payment policy for bevacizumab (Avastin) to treat wet age-related macular degeneration, a government report concluded.

FDA Warns of Clot Risk with Yaz, Other OCs

Labels for oral contraceptives that contain drospirenone will now note that studies have shown up to a threefold increased risk of blood clots compared with other birth control pills.

FDA Adds More Warnings for Lipitor, Crestor, and Zocor

WASHINGTON -- Statins may cause drug-drug interactions for patients taking drugs to treat HIV/AIDS or hepatitis C, according to a new statin warning from the FDA.

Clinical Notes: Beware the Seat Heater

麻豆传媒 debuts a new regular feature, a roundup of clinical news you might otherwise have missed. This week we led with a report that heated car seats can leave passengers with "toasted skin syndrome."

FDA Panel Split Over Inhaled Antipsychotic

WASHINGTON -- An FDA advisory panel punted on the question of approval for an inhaled version of the antipsychotic drug loxapine (Adasuve) to treat agitation in bipolar and schizophrenic patients, despite the risk for respiratory side effects.

Side Effects of Loxapine Aerosol Raise FDA Concerns

WASHINGTON -- Although staccato loxapine (Adasuve) appears to be effective in calming schizophrenic and bipolar patients, concerns remain about the drug's pulmonary side effects, according to a review by FDA staff members.

FDA Revokes Avastin Approval for Breast Cancer

WASHINGTON -- The FDA has announced that bevacizumab (Avastin) is no longer approved for the treatment of breast cancer; the Genentech drug retains its other indications and will remain on the market.

AMA Adopts Policies on Circumcision, Gun Safety

The American Medical Association (AMA) House of Delegates has adopted a number of new policies at its interim meeting, including policies on male circumcision, physician discussion of gun safety, and a new medical coding system that will go into effect in 2013.

Linezolid Toxic With Prozac, Other SSRIs, FDA Warns

The FDA has issued an updated statement on the potential for serious central nervous system toxicity when patients taking serotonergic psychiatric drugs are treated with the antibacterial agent linezolid (Zyvox).

Parkinson's Drug Doesn't Slow Disease Progress, FDA Staff Says

WASHINGTON -- Azilect (rasagiline), which is already approved to treat symptoms of Parkinson's disease, does not appear effective at slowing progression of the neurodegenerative disease, according to an FDA review.

Healthcare Key Is Access Not Cost

Long wait-times for appointments and inability to take time off work are more common barriers to healthcare access than financial hardship, a new study found.

Medicare to Keep Paying for Avastin

WASHINGTON -- Medicare will continue to pay for bevacizumab (Avastin) when it's used to treat metastatic breast cancer, even if the FDA decides to remove that indication from the drug, a spokesman for the Centers for Medicare and Medicaid Services (CMS) said.

AMA: House of Delegates Backs Individual Mandate

CHICAGO -- The American Medical Association's House of Delegates has reaffirmed its support of individual responsibility -- including a requirement that most U.S. residents buy health insurance -- as the foundation of universal coverage.

AMA: Delegates Sharply Divided on Individual Mandate

CHICAGO -- As the constitutionality of the individual mandate is debated in the nation's courts, the issue has emerged as a lightning rod in the American Medical Association's annual House of Delegates meeting here.

FDA Warns of High-Grade Prostate Ca Risk With BPH Drugs

WASHINGTON -- The FDA has issued a warning of an increased risk of high-grade prostate cancer with the 5-alpha reductase inhibitors finasteride (Proscar) and dutasteride (Avodart), currently approved to treat benign prostatic hypertrophy.

FDA Panel Recommends New Rules for Kids' Acetaminophen

SILVER SPRING, Md -- For the first time since they came on the market in the 1950s, children's liquid medicines containing acetaminophen would carry dosing instructions for children younger than 2, if the FDA follows the unanimous recommendation of a federal panel.

Primary Care Still Hard to Get in Massachusetts

WASHINGTON -- More than half of primary care practices in Massachusetts are not accepting new patients, and wait times for many new patients continue to lengthen five years after the state passed its landmark healthcare reform law.

Rx Data-Mining Case Reaches Supreme Court

WASHINGTON -- The U.S. Supreme Court will hear arguments Tuesday in a case involving a state law that restricts pharmaceutical companies' use of physician prescribing records.

AAPM: 'Focused Factories' on Healthcare Horizon

WASHINGTON -- The next big thing in healthcare won't be large, all-purpose healthcare organizations -- it will be 'focused factories' for treating specific problems, a Harvard economist says.

Medicare Paid Millions for Viagra

WASHINGTON -- Despite a rule that bars Medicare reimbursement for erectile dysfunction treatment, the Centers for Medicare and Medicaid Services (CMS) paid out $3.1 million for the drugs in 2007 and 2008, a new government report found.

Standards Issued for Healthcare Interpreter Services

All U.S. healthcare organizations must be able to talk with patients about their care in a language they can understand, according to new Joint Commission standards.

Pfizer Moves May Dim Prospect for New Antibiotics

Infectious disease specialists are concerned that a corporate decision by Pfizer to scale back its R&D spending next year -- plus a transition to China -- will further slow development of new antibiotic drugs.

More Vets Approved for Agent Orange Claims

WASHINGTON -- Veterans who served in Korea from 1968 through 1971 were probably exposed to Agent Orange, which makes them eligible for treatment at VA medical centers, according to a ruling from the Department of Veterans Affairs.

FDA Panel: Keep ECT Devices as High Risk

GAITHERSBURG, Md. -- The FDA should continue to regulate electroconvulsive therapy (ECT) machines as high-risk devices for treating depression and most other conditions for which ECT is typically used, members of the agency's Neurological Devices Advisory Committee agreed.

FDA Panel Rejects Cystic Fibrosis Drug

SILVER SPRING, Md. -- An FDA advisory committee has voted against approval of liprotamase (Sollpura), a pancreatic enzyme product for cystic fibrosis and other diseases that cause pancreatic insufficiency, saying there is not enough evidence that the drug works better than agents already on the market.

FDA Cans Alcoholic Beverages that Contain Caffeine

The FDA has acted to effectively ban the sale of beverages that combine caffeine and alcohol, including Four Loko and Joose, by declaring that caffeine is an unsafe food additive for alcoholic beverages.

FDA Panel Looks at Trials of Devices to Treat Depression

GAITHERSBURG, Md. -- An FDA advisory panel met Friday to discuss how to analyze trials designed to test devices used to treat depression, but didn't offer the FDA any clear-cut guidance.

Not Enough Evidence to Use BMP Off-Label, Panel Says

BALTIMORE -- A Medicare advisory committee has voted that there is not enough evidence to warrant off-label use of recombinant human bone morphogenetic protein, or BMP, for bone surgery.

Take Rosiglitazone Off the Market, Says FDA Staff

WASHINGTON -- Rosiglitazone (Avandia) should be pulled from the market because of the "serious" cardiovascular risk the diabetes drug poses, which exceeds that of competitor pioglitazone (Actos), FDA staff reviewers again recommended.

FDA Advisers Turn Down New RSV Drug

WASHINGTON -- An FDA advisory committee recommended Wednesday that the agency not approve the investigational drug motavizumab to treat respiratory infections, deciding that it didn't offer any advantages over the drug already on the market, and that it may be more dangerous.

FDA Panel Recommends Limited Use of Investigational Antipsychotic

SILVER SPRING, Md. -- An FDA advisory panel voted to recommend FDA approval for sertindole (Serdolect) to treat schizophrenia, but only for a subgroup of patients that the agency would have to define.

New Jersey Doctor-Delegate Sees Big Trouble in Universal Coverage

ST. PAUL, Minn. -- Ben Chouake, M.D., of Cliffside Park, N.J., an internist and emergency medicine specialist, is the son of holocaust survivors. He is a delegate for John McCain at the Republican National Convention here.

Hillary Clinton Touts Obama's Goal of Healthcare for All

DENVER -- Despite tortuous battles during the presidential primaries over the nuances of healthcare reform, Sen. Hillary Clinton was ringing in her support for Sen. Barack Obama's goals at the Democratic National Convention here.

McCain Cites 'Strong Evidence' of Link Between Vaccines and Autism

WASHINGTON -- Sen. John McCain, the presumptive Republican candidate for president, has given credibility to "strong evidence" of a link between autism and thimerosal in childhood vaccines. He cited "divided scientific opinion" on the matter.

Presidential Frontrunners Play it Close to the Vest on Healthcare

WASHINGTON -- If the devil is in the details, the strengths and weaknesses of the healthcare positions of the major presidential candidates of both parties are only beginning to emerge.

'Second-Tier' Republicans Sound Off on Health Care

WASHINGTON -- As dark-horse candidates often leave footprints on the political trail, three Republicans vying for the presidential nomination may have an impact on the health care debate.