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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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