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Washington Watch

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.

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.

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.

FDA Panel Wary on Making Bladder Control Drug OTC

WASHINGTON -- An FDA advisory panel on Friday voted against recommending making oxybutynin transdermal patch (Oxytrol) available over-the-counter for overactive bladder in women.

Meningitis: FDA Warns of 'Light Therapy' Claims

A Tennessee company made false claims that its "light therapy" has benefits for fungal meningitis, the FDA said.

AHA: No Excess Bleeding Risk with Dabigatran

LOS ANGELES -- Patients starting dabigatran (Pradaxa) did not have a higher risk of bleeding compared with new users of warfarin, according to a postmarketing data review by the FDA.

Recall: Device Sucks Life From Patient

A suction system for collecting surgical waste apparently killed one patient and seriously injured another, prompting its maker to recall it and several related devices, the FDA said.

Watchdog Group Wants Black Box on BP Meds

WASHINGTON -- The consumer watchdog group Public Citizen petitioned the FDA to add a black box warning to three classes of hypertension drugs, cautioning against their combined use.

Romney Takes Daily Statin, Aspirin

WASHINGTON -- Republican presidential nominee Mitt Romney has hyperlipidemia and takes a statin and low-dose aspirin daily, according to a letter from his personal physician released Friday.

Viagra from Online Sources Mostly Fake

CHICAGO -- Most of the sildenafil (Viagra) sold online is counterfeit and contains far less of the active ingredient than the real thing, researchers said here.

California Docs Sue Aetna Over Out-of-Network Denials

Several medical groups and more that 50 individual physicians in California are suing Aetna, claiming that the insurer often wrongly denies coverage for patients accessing out-of-network providers.

FDA Rejects Merck Sarcoma Drug

WASHINGTON -- The FDA has rejected the approval application for the sarcoma drug ridaforolimus, according to drug developer Merck.

FDA Asked to Take Ban Use of Pesticide for Head Lice

A congressman has called on the FDA to ban the pesticide lindane as a treatment for head lice in children; the agency has already demoted it from a first-line therapy.

Fake Adderall Pops Up on Internet

The FDA has issued a warning about counterfeit generic Adderall tablets that are being sold over the Internet.

FDA Panel Says Yes to Home HIV Test

GAITHERSBURG, Md. -- An FDA advisory committee has voted 17-0 to recommend approval of the OraQuick In-Home HIV Test. If approved, it will be the first over-the-counter home HIV test.

FDA Staff Flags False Results of Home HIV Test

WASHINGTON -- FDA reviewers expressed concern over the risk of false negative and false positive results if the agency approved the first-ever over-the-counter at-home HIV test.

Prolia Linked to Serious Skin Side Effects

RALEIGH, N.C. -- More than 40 serious cutaneous adverse events linked to the osteoporosis formulation of denosumab (Prolia) were discovered in a review of FDA records, investigators reported here.

FDA: Revlimid Linked to Second Cancers

Treatment of multiple myeloma with lenalidomide (Revlimid) as maintenance therapy is associated with an increased risk of second primary cancers, the FDA warned.

Lewin Group Founder Dies

Lawrence (Larry) Lewin, founder of the healthcare consulting firm The Lewin Group, has died at age 74, according to an announcement on the organization's website.

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

番茄社区 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.

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