FDA Alerts
Latest FDA Alerts News
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FDA Panel Sends Mixed Messages on Rare Disease Drug
WASHINGTON -- An FDA advisory panel considering an investigational drug to treat a rare nerve disorder agreed that a study of the drug, Vyndaqel, did not provide
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FDA Advisory Panel Approves Home HIV Test Kit
Americans are a step closer to being able to quickly determine in the privacy of their own homes whether they’re infected with HIV, the virus that causes AIDS. An advisory panel to the U.S. Food and Drug Administration Tuesday voted 17-0 in favor of approving the...
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FDA Panel Gives Nod to New Diet Drug Lorqess
SILVER SPRING, Md. -- An FDA advisory committee has voted 18-4, with cardiovascular complications. An FDA advisory committee recommended in March 2012 cardiovascular side effects and an FDA advisory committee endorsed approval by a 20
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FDA Warning: Infection Risks From Contaminated Ultrasound Gelcolonization (the presence of bacteria at a site without any signs of infection) or infection, but the risk remains present," the FDA alert said. It warned that biopsies can let bacteria get into tissues, causing an abscess or severe bloodstream infection called
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FDA Panel Recommends Approval of Diet Drug Qnexachronically obese outweighed the risks of birth defects and cardiovascular problems that have been associated with the drug. An FDA advisory panel recommended against approval in 2010 over concerns about the drug's side effects, and the FDA rejected it shortly
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Renewed Warning on Baby Acetaminophen
outside safety experts to reduce exactly this sort of dosing confusion. Following recommendations from a 2009 meeting of two FDA advisory committees, major manufacturers that previously made liquid acetaminophen in different strengths agreed to switch production
News
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Plan B: HHS Prevents Morning After Pill From Hitting Drug Store Shelvesprescription. The move has sparked outrage among some doctors, who say politics trumped science. "The original FDA Advisory committee that recommended approval for Plan B, was virtually unanimous in its recommendation, and didn't find reason
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Breast Cancer: FDA Revokes Avastin Approvalcan cause severe high blood pressure, bleeding, heart failure and perforations in the nose, stomach and intestines, an FDA advisory panel in June recommended revoking its approval. The recommendation triggered an outcry from breast cancer patients who
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Colorado Cantaloupes Prompt Warning After Multi-State Listeria Outbreakcollected product and environmental samples," the FDA said in the statement. "Laboratory testing is under way." Most FDA recalls are voluntary, but since January 2011, the FDA now has the authority to require a recall through the Food Safety Modernization
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FDA Panel Waffles on Limiting Duration of Bisphosphonate UseADELPHI, Md. -- A U.S. Food and Drug Administration advisory committee wants the agency to limit the duration of bisphosphonate therapy for treatment of osteoporosis, but the committee could not agree on what that time limit should be. Earlier this year, the FDA required that all bisphosphonates
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FDA Committee to Review Osteoporosis Drug Safety
A U.S. Food and Drug Administration advisory committee meets Friday to review the safety of a popular class of osteoporosis drugs called bisphosphonates amid worry that their long-term use could cause rare fractures of the thighbones and death of the jawbone. According to the Wall Street Journal,
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Massage Device Poses Strangulation Risk, Says FDAThe FDA has issued a safety communication for the ShoulderFlex Massager because of a risk of strangulation, or other serious injury, with the device. The Consumer Safety Products Commission has received reports of one death and another near strangulation, the FDA said . The fatality and near
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Medicare to Continue to Cover Avastin Regardless of What FDA Decides
Medicare and Medicaid. "The FDA decision, when it comes, does not affect CMS," McLeod told Reuters. An FDA advisory committee recommended unanimously that Avastin no longer be used to treat breast cancer, saying that the risks of the drug
Videos
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ADHD Drugs: How Safe Are They?Drugs that treat ADHD are under scrutiny by an FDA advisory committee .
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Female Viagraanytime in the near future. An FDA advisory panel of seven women and four a little bit about what the FDA advisory . Panel determined this drug is not the FDA advisory committee their job is to look at the
the FDA advisory committee their job is to look at the drug and okay isn't -- factor and it that they. And -- they look at -
'Robo Tripping' May Cause Cough Medicine Crackdownyou know thank you just walking anywhere. Like in any city in the country and. Didn't drug. Still today an FDA advisory committee voted to keep these cough medicines available prescription in keeping with the industry group position. The industry
Still today an FDA advisory committee voted to keep these cough medicines available -- prescription in keeping with the industry group position. The industry says they key is -
Does Avandia Increase Heart Attack Risk?also seemed to carry a higher risk of stroke and heart failure. The news comes only a couple of weeks before an FDA advisory committee will meet to decide the fate of this popular diabetes drug. Considering that heart disease is already a leading
heart failure. The news comes only a couple of weeks before an FDA advisory committee will meet to decide the fate of this popular diabetes drug. Considering that heart disease is already a leading cause of death -
'Robo Tripping' May Cause Cough Medicine Crackdownat Wal-Mart now is walking anywhere. Like in any city in the country and. Didn't drugs. Still today an FDA advisory committee voted to keep these cough medicines available prescription in keeping with the industry group position. The industry
Still today an FDA advisory committee voted to keep these cough medicines available -- prescription in keeping with the industry group position. The industry says the key is -
Kellogg's Cereal Equal (Mal)nutrition?important jobs. I want to take advantage of another area of your expertise says you know a drug called Was before the FDA advisory committee yesterday they decided not to recommend approval. Because of concerns about increased risks for suicidal thoughts
expertise says you know a drug called -- Was before the FDA advisory committee yesterday they decided not to recommend approval. Because of concerns about increased risks for suicidal thoughts and may be other -- of -
Foster Kids and Meds: Doctors Questionedwith a month. the FDA. I know this is an issue that it has been discussed and Odyssey we're well aware of it. Whether. FDA advisory or some sort of announcement was it would have an impact would be a possibility to consider you're sitting at home at night
it has been discussed and Odyssey we're well aware of it. Whether. FDA advisory or some sort of announcement was it would have an impact -- would be a possibility to consider you're sitting at home
