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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.

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.

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.

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.

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.

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.

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.

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.

Public Citizen's Wolfe Still Needling FDA

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

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.

NuPathe's Patch for Migraine Wins FDA Approval

WASHINGTON -- Adults with migraine will soon have a new treatment option -- Zecuity, a transdermal, battery-powered sumatriptan patch.

'Rugby' Iron Pills Pulled Due to Drug Mix-Up

锘縒ASHINGTON -- The manufacturer of an iron supplement has recalled one lot of the product due to bottles of the affected lot potentially containing anti-nausea tablets instead.

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.

FDA: Booze and Xyrem Are Dangerous Mix

WASHINGTON -- The FDA is warning healthcare professionals that patients taking the muscle weakness and narcolepsy drug sodium oxybate (Xyrem) should not consume alcohol or use central nervous system depressants.

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.

Oxygen Devices Recalled

WASHINGTON -- The FDA has issued a class I recall of several models of oxygen concentrators because of a potential fire hazard.

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.

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