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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.

Apr 10, 2012

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.

Mar 01, 2012

Clinical Notes: Beware the Seat Heater

口袋女优 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."

Feb 26, 2012

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.

Dec 12, 2011

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.

Dec 10, 2011

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.

Nov 18, 2011

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.

Nov 16, 2011

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).

Oct 21, 2011

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.

Oct 14, 2011

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.

Jun 30, 2011

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.

Jun 20, 2011

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.

Jun 09, 2011

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.

May 18, 2011

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.

Feb 04, 2011

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.

Jan 12, 2011

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.

Nov 17, 2010

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.

Oct 08, 2010

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.

Jul 09, 2010

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.

Jun 03, 2010