The FDA has changed the package insert for Avastin® (bevacizumab) to include information about newly identified risks for the drug including

• Loss of ovarian function (ovarian failure).
• Bone death in the jaw (osteonecrosis).
• Bleeding and additional blood clots in patients who have already had a clot in their veins while on Avastin.

Changes to the Avastin label were announced on September 30, 2011. Read the rest of this entry »

If you missed the FDA Webinar on Drug Shortages last Friday, you can

Watch a video of the entire presentation, including questions.

Download the webinar slides.

The webinar, led by Captain Valerie Jensen, R.Ph., Associate Director for the FDA’s Drug Shortage Program, discusses how the FDA responds to drug shortages and what they are doing to try to prevent shortages of medically necessary drugs. Read the rest of this entry »

Colorectal Cancer News in a Nutshell

Summer’s over. The black squirrels in the front yard are scurrying around hunting acorns and my inbox is full of neat nuggets of colorectal cancer news — and I don’t want to leave them buried all winter.

So here they are in brief.  You can check the links for more details.

Mixed Results Using Acupuncture for Radiation Nausea

The good news is that almost all patients felt they had less nausea after either real or sham acupuncture to manage nausea and vomiting during radiation therapy.  Nine out of ten wanted more treatments. Read the rest of this entry »

Drug shortages in the US are a growing crisis, members of Congress were told last Friday, September 23.  And there is no single reason why this is happening and no easy solutions to the problem.

Problems lie mostly in older generic versions of sterile injectable drugs, which are low-priced and

• complicated to manufacture
• made by a only a few companies
• manufactured in aging plants where quality is hard to maintain.

Read the rest of this entry »

Quick update

Fight Colorectal Cancer is watching the House Energy and Commerce Subcommittee on Health hearing Examining the Increase in Drug Shortages.

The hearing began at 9:30 this morning, September 23, 2011, and will continue after a recess.

You can watch it with us on UStream Live.

Testimony already from Howard K. Koh, Assistant Secretary for Health, Department of Health and Human Services, who was accompanied by Dr. Sandra L. Kweder from the FDA.  Both answered questions from Subcommittee Members.