Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Potentially fatal toxicities occur with off-label use of cancer drugs

21.12.2004


Food and Drug Administration policies prevent pharmaceutical manufacturers from informing patients about potentially fatal toxicities that occur with some cancer drugs -- policies that should be revised immediately, according to Northwestern University researchers.

Andrew M. Evens, D.O., instructor in medicine, and Charles L. Bennett, M.D., professor of medicine, Northwestern University Feinberg School of Medicine, have called for an immediate revision of these FDA policies, particularly because the drug thalidomide, which was approved by the FDA as an off-label cancer treatment in 1998, has been reported to have caused potentially fatal blood clots in the legs and the lungs in over 190 cancer patients.

Virtually all patients who have received thalidomide over the past six years have received the drug for cancer, making this drug the only one in the country whose use is exclusively off label. The FDA strictly restricts discussion or dissemination of information to physicians and patients to "on label" indications, which prevents the pharmaceutical manufacturer from advising cancer patients about the side effects of thalidomide when it is used to treat cancer.



Moreover, despite an FDA mandate that all health care personnel and patients involved with thalidomide treatments participate in the preventive System for Thalidomide Education and Prescribing Safety (STEPS), the program does not provide patients, pharmacists or health care providers with information on thromboembolisms. Evens presented the RADAR (Research on Adverse Drug Events and Reports) data on the thalidomide-associated blood clots on at the 46th Annual Meeting of the American Society of Hematology in early December.

The Northwestern study identified the occurrence of potential fatal blood clots in the legs and the lungs in up to 20 percent or more of cancer patients who received thalidomide. The highest rates of thromboembolism occurred in patients who received concurrent treatment with thalidomide plus chemotherapy (18 percent) versus blood clots associated with thalidomide-corticosteroid combinations (13 percent) and single-drug treatment (5 percent).

Thalidomide, banned initially in 1962, has had a remarkable resurgence since 1998 for cancer, although its formal FDA approval is as a treatment of skin complication of the rare illness, leprosy. "Given the current controversies about the FDA and pharmaceutical safety, our findings provide additional evidence that dramatic changes in the way the FDA address patient safety are needed," Even said.

Evens and Bennett are faculty physicians in the department of medicine, division of hematology/oncology, at Northwestern University Feinberg School of Medicine and researchers at The Robert H. Lurie Comprehensive Cancer Center of Northwestern University. The RADAR project, led by Bennett, is supported by a $5 million grant from the National Cancer Institute.

Elizabeth Crown | EurekAlert!
Further information:
http://www.northwestern.edu

More articles from Health and Medicine:

nachricht New antibody analysis accelerates rational vaccine design
09.08.2018 | Scripps Research Institute

nachricht Distrust of power influences choice of medical procedures
01.08.2018 | Johannes Gutenberg-Universität Mainz

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: New interactive machine learning tool makes car designs more aerodynamic

Scientists develop first tool to use machine learning methods to compute flow around interactively designable 3D objects. Tool will be presented at this year’s prestigious SIGGRAPH conference.

When engineers or designers want to test the aerodynamic properties of the newly designed shape of a car, airplane, or other object, they would normally model...

Im Focus: Robots as 'pump attendants': TU Graz develops robot-controlled rapid charging system for e-vehicles

Researchers from TU Graz and their industry partners have unveiled a world first: the prototype of a robot-controlled, high-speed combined charging system (CCS) for electric vehicles that enables series charging of cars in various parking positions.

Global demand for electric vehicles is forecast to rise sharply: by 2025, the number of new vehicle registrations is expected to reach 25 million per year....

Im Focus: The “TRiC” to folding actin

Proteins must be folded correctly to fulfill their molecular functions in cells. Molecular assistants called chaperones help proteins exploit their inbuilt folding potential and reach the correct three-dimensional structure. Researchers at the Max Planck Institute of Biochemistry (MPIB) have demonstrated that actin, the most abundant protein in higher developed cells, does not have the inbuilt potential to fold and instead requires special assistance to fold into its active state. The chaperone TRiC uses a previously undescribed mechanism to perform actin folding. The study was recently published in the journal Cell.

Actin is the most abundant protein in highly developed cells and has diverse functions in processes like cell stabilization, cell division and muscle...

Im Focus: Lining up surprising behaviors of superconductor with one of the world's strongest magnets

Scientists have discovered that the electrical resistance of a copper-oxide compound depends on the magnetic field in a very unusual way -- a finding that could help direct the search for materials that can perfectly conduct electricity at room temperatur

What happens when really powerful magnets--capable of producing magnetic fields nearly two million times stronger than Earth's--are applied to materials that...

Im Focus: World record: Fastest 3-D tomographic images at BESSY II

The quality of materials often depends on the manufacturing process. In casting and welding, for example, the rate at which melts solidify and the resulting microstructure of the alloy is important. With metallic foams as well, it depends on exactly how the foaming process takes place. To understand these processes fully requires fast sensing capability. The fastest 3D tomographic images to date have now been achieved at the BESSY II X-ray source operated by the Helmholtz-Zentrum Berlin.

Dr. Francisco Garcia-Moreno and his team have designed a turntable that rotates ultra-stably about its axis at a constant rotational speed. This really depends...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Within reach of the Universe

08.08.2018 | Event News

A journey through the history of microscopy – new exhibition opens at the MDC

27.07.2018 | Event News

2018 Work Research Conference

25.07.2018 | Event News

 
Latest News

'Building up' stretchable electronics to be as multipurpose as your smartphone

14.08.2018 | Information Technology

During HIV infection, antibody can block B cells from fighting pathogens

14.08.2018 | Life Sciences

First study on physical properties of giant cancer cells may inform new treatments

14.08.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>