FDA Approves Risk Management Plan for ESAs

Cancer patients will learn more from their doctors about the possible risks and benefits of erythropoiesis-stimulating agents (ESAs) to manage anemia during chemotherapy under a new program just approved by the FDA.

ESAs can be given to chemotherapy patients to reduce the need for blood transfusions.  However, there can be problems with ESAs including causing some tumors to grow faster or some patients to die sooner.  They can also increase risk for blood clots, heart failure, heart attack or stroke.

ESAs, including Procrit®, Epogen®, and Aranesp®, are now covered by a REMS or Risk Evaluation and Mitigation Strategy which requires that patient receive a Medication Guide from their health care providers that tells them how to safely use an ESA drug.

In addition, health care providers who use ESAs with their patients must be be actively enrolled in  the APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) Oncology program and receive training in their safe use.  Continue reading…

Posted by Kate Murphy on February 23rd, 2010
Posted in: Research & Treatment News | No Comments »
Tags: Aranesp, Epogen, erythropoetin stimulating agents, ESA, FDA, Procrit

FDA Warns About Maalox Mixups

Think that Maalox Total Relief is the same as the traditional Maalox liquids?

It isn’t, and the FDA wants you to know that.

Although both are available over the counter, they are intended to treat different medical conditions.  Maalox Total Relief contains bismuth subsalicylate, which is related to aspirin and can cause bleeding and other serious side effects. Continue reading…

Posted by Kate Murphy on February 18th, 2010
Posted in: Research & Treatment News | No Comments »
Tags: FDA, heartburn, Maalox, salicylates

Funding for Cancer Research and Control Programs in the President’s FY 2011 Budget

The fiscal year 2011 budget process got underway today when President Obama sent Congress his budget proposal.  The President’s $3.8 trillion budget includes a three-year freeze on non-security discretionary spending in order to save about $250 billion over 10 years and start narrowing the $1.6 trillion gap between proposed budget outlays and tax receipts.  The freeze caps the overall level of spending so that some programs get increases (for example, cancer research at NIH and NCI receives a funding increase), while other programs (including some of the cancer control programs at the CDC) are cut.  The freeze comes on top of a proposal to eliminate, or scale back, 120 programs in order to save more than $20 billion.

U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius issued the following statement of support,

“[u]nder this budget, we will provide the health and human services that Americans depend on more effectively, slashing waste and focusing programs on results.  And we’ll make many of the necessary investments our country has been putting off for years, including investments in fighting health care fraud, strengthening our public health infrastructure, and getting serious about health and wellness,” said Sebelius. “This budget is a big step toward a healthier, stronger America.” Continue reading…

Posted by Catherine Knowles on February 1st, 2010
Posted in: Policy & Advocacy News | No Comments »
Tags: Budget, FDA, NCI, NIH, President Obama

FDA approves highly concentrated liquid morphine for severe pain

In good news for cancer patients at the end of life,  the Food and Drug Administration has approved a concentrated liquid morphine to relieve acute and chronic pain in patients where other opiates are no longer working.

Although concentrated doses of liquid morphine have used to manage pain for opiate-tolerant patients for some time, the oral concentrated dose was not FDA approved.

The FDA has worked with Roxane Laboratories, the only manufacturer of the 20mg/mL formulation, to be sure that adequate supplies are available to patients in need.  Continue reading…

Posted by Kate Murphy on January 29th, 2010
Posted in: Research & Treatment News | No Comments »
Tags: FDA, liquid opiates

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 follow C3. Continue reading…

Posted by Kate Murphy on January 20th, 2010
Posted in: Research & Treatment News | 2 Comments »
Tags: drug disposal, FDA