Tag Archives: FDA

Colorectal Cancer News Briefs: January 20

This week we’re sending you news about SMARxT Disposal of leftover medicine and a new resource from FDA that makes finding information on their website easier. We’re experimenting with a little different format for the weekly briefs. You’ll find two different blogs — one with research news and another with upcoming events and consumer information. In this way, we hope to include a bit more detail while still keeping the individuals items brief and easy to read. Watch for Kate Murphy on Twitter this weekend.  She’ll be sending Tweets from the ASCO GI Symposium in Orlando.  Follow C3 news and research updates @FIGHTCRC.   Here’s more information on joining Twitter to

Colorectal Cancer News in Brief: December 29

Briefly Factors related to the patient, year of surgery, and tumor itself and not surgeons or pathologists explain low lymph node counts after colon and rectal surgery.  Lack of colorectal cancer screening leads to emergency surgery and complications and death among the elderly. Americans without health insurance are more likely to die, even when factors like overall health, smoking, and income are considered, and cancer patients who have support from family and friends at diagnosis are much more likely to look on the entire experience as a chance for positive growth years later. Finally, FDA has a good video to help people avoid health care frauds. Happy Holidays.  Enjoy family,

FDA Authorizes Emergency Use of IV Peramivir for Some H1N1 Patients

In response to a request from the Centers for Disease Control, the Food and Drug Administration will allow emergency use of the investigational antiviral intravenous drug peramivir in some hospitalized patients with 2009 H1N1 influenza infection.  The Emergency Use Authorization (EUA) is effective for both adults and children from birth to age 17. There are currently no intravenous (IV) antiviral medicines approved for influenza. 

FDA: Check Power Cords on Medical Devices

The Food and Drug Administration warns health care facilities and people who use medical devices at home to check the power cords for wear and tear, especially if oxygen is being used nearby. The FDA has more than 120 reports of sparking, charring, and fires from cords used by two device manufacturers, Hospira Inc. and Abbott Nutrition, and is concerned that there may be similar problems with cords on other devices. 

Colorectal Cancer News in Brief: October 16

Briefly: The elderly are much more likely to have their colons perforated during colonoscopy, and inflammatory bowel disease patients who are part of a colonoscopy surveillance program before a diagnosis of colorectal cancer are diagnosed at an earlier stage and have much better survival than patients who don’t have colonoscopies before diagnosis. There is help online for seniors and their caregivers who are having surgery and cancer survivors who are coping with “chemobrain”.  The FDA is cracking down on the unapproved marketing of some codeine drugs.

Colorectal Cancer News in Brief: October 9

Briefly: In research this week, human embryonic stem cells produced an immune response in mice with colon cancer, and discussing strong pain medicines with cancer patients reduces their pain by about 20 percent. The Food and Drug Administration has found many dietary supplements contaminated with prescription drugs not listed on the label, some at several times higher than the recommended dose.  In other FDA news, Spectrum Pharmaceuticals was unable to get FDA approval for use of Fusilev® for metastatic colorectal cancer.

FDA Issues Final Rule to Clarify Patient Access to Experimental Drugs

In an effort to broaden and clarify access by individual patients to experimental medicines that have not yet obtained FDA approval or haven’t been approved for a new use, the Food and Drug Administration issued two new rules on August 12, 2009. The Expanded Access rule establishes how seriously ill individual patients or groups of patients can obtain investigational medicines while at the same time preserving the clinical trials process. The Charging rule clarifies when a manufacturer of an investigational drug may charge for it and what costs can be recovered in those charges. In addition, the FDA established a website for consumers to explain access to investigational drugs through

FDA Sets Limits on Darvon and Darvocet but Doesn't Recommend Market Withdrawal

Despite recommendations from two of its advisory committees for a phased withdrawal of propoxyphene-containing products, the Food and Drug Administration won’t be taking them off the market.  Instead they’ll require a black box warning on the label and a medication guide for patients letting them know of the serious risks of death from effects on the heart or overdose. Best known by brand names Darvon® and Darvocet®, the pain medicines have a high risk for fatal overdose when not used as prescribed.  Opiates, they are prescribed for mild to moderate pain.  However, the FDA says that benefits of the medicines when taken at recommended doses outweigh risks at this time.

Colorectal Cancer News in Brief: July 25

Research shows how lemon and lavender ease stress by acting on the immune system and gene expression. In colon cancer, patients with lots of immune-system cells in their tumors have better survival, and men and younger people risk more severe Erbitux rash. In other headlines, FDA warns about toxic chemicals in electronic cigarettes.  Save  August 29th to walk across the Big Dam in Little Rock, Arkansas with the Colon Club.

FDA Approves Labeling Changes for Erbitux and Vectibix to Reflect KRAS Status

The Food and Drug Administration (FDA) has approved labeling changes for Vectibix and Erbitux to reflect studies that found the two drugs are not effective in patients whose tumors have mutated KRAS. The FDA has updated the indication and usage for Vectibix™  (panitumumab) and Erbitux® (cetuximab) to include a statement that: retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX is not recommended for the treatment of colorectal cancer with these mutations. Retrospective subset analyses of metastatic or advanced colorectal cancer trials have not

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