January 6th, 2012 by RyanDuBosar in News
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Cephalosporins will be used in livestock only for very specific exceptions, after years of debate about the role of antibiotic resistance in farming and how it leads to new strains of microbes with the potential to shift into humans.
The FDA took this step to preserve the effectiveness of cephalosporin drugs for treating disease in humans, the agency announced in a press release.
In 2008, the FDA issued and then revoked an order that prohibited cephalosporins in food-producing animals with no exceptions. Three years later, the agency’s ban includes several exceptions:
–It doesn’t limit cephapirin, which the FDA doesn’t think contributes to antimicrobial resistance;
–Veterinarians will still be able to Read more »
*This blog post was originally published at ACP Internist*
December 22nd, 2011 by John Di Saia, M.D. in News, Opinion
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The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults. The FDA issued Warning Letters to Bakersfield Surgery Institute Inc.; Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to 1-800-GET-THIN because Lap-Band is a restricted medical device that is misbranded as a result of misleading advertising by these groups. In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.
Source: fda.gov/NewsEvents/Newsroom/PressAnnouncements
/ucm283455.htm#.TueG3YY1aZY.facebook
We have blogged on 1-800-Get-Thin and Lap-band surgery in general before. Read more »
*This blog post was originally published at Truth in Cosmetic Surgery*
December 16th, 2011 by GruntDoc in Opinion, Research
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I read this headline and said, “Wow!, finally I won’t need to CT all those patients’ heads!”
FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
Helps to determine if immediate CT scan is needed
The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.
via Press Announcements > FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull.
But then, wait, said I, is it any good? Read more »
*This blog post was originally published at GruntDoc*
November 12th, 2011 by JessicaBerthold in Research
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“Wow, Celexa?”
“Yeah, who knew?”
I overheard this conversation in the ladies’ room immediately after a session speaker advised treating agitation and aggression in dementia with citalopram. Indeed, there was a bit of a murmur in the audience when Dr. Aleta Borrud made the suggestion during her talk at the Mayo Update in Hospital Medicine 2011 course.
Part of the reason for the reaction may be– as a physician I spoke with noted– that Read more »
*This blog post was originally published at ACP Hospitalist*
October 19th, 2011 by AndrewSchorr in Health Policy, Interviews
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If you’ve read my blogs for a while, or look up some past blogs, you’ll see I have been frustrated at times with the FDA. Yes, they have a tough job protecting us from medical products that are unsafe and/or ineffective. But when it comes to cancer, where we have few “homerun” therapies, I wish they were a bit more liberal. A “bunt single” might be good enough. You may have read how I have been critical of Dr. Rick Pazdur, the FDA leader for oncology drug approval. Some desperate patients and family members have referred to him as “Dr. No.”
Just the other day I interviewed a respected breast cancer survivor and patient advocate who has high respect for Dr. Pazdur. Musa Mayer of New York City is a 22-year breast cancer survivor and author of three books about breast cancer. She’s devoted her life to educating other patients about cancer and also playing a role in public policy. She has become a favorite patient representative on FDA cancer advisory boards and regularly weighs in when breast cancer drugs are being considered.
In my interview with Musa, she explained Read more »
*This blog post was originally published at Andrew's Blog*
