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 3D images of cancer cells in the body: Medical physicists from Halle present new method
16.05.2018 | Martin-Luther-Universität Halle-Wittenberg

nachricht Better equipped in the fight against lung cancer
16.05.2018 | Friedrich-Alexander-Universität Erlangen-Nürnberg

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: Explanation for puzzling quantum oscillations has been found

So-called quantum many-body scars allow quantum systems to stay out of equilibrium much longer, explaining experiment | Study published in Nature Physics

Recently, researchers from Harvard and MIT succeeded in trapping a record 53 atoms and individually controlling their quantum state, realizing what is called a...

Im Focus: Dozens of binaries from Milky Way's globular clusters could be detectable by LISA

Next-generation gravitational wave detector in space will complement LIGO on Earth

The historic first detection of gravitational waves from colliding black holes far outside our galaxy opened a new window to understanding the universe. A...

Im Focus: Entangled atoms shine in unison

A team led by Austrian experimental physicist Rainer Blatt has succeeded in characterizing the quantum entanglement of two spatially separated atoms by observing their light emission. This fundamental demonstration could lead to the development of highly sensitive optical gradiometers for the precise measurement of the gravitational field or the earth's magnetic field.

The age of quantum technology has long been heralded. Decades of research into the quantum world have led to the development of methods that make it possible...

Im Focus: Computer-Designed Customized Regenerative Heart Valves

Cardiovascular tissue engineering aims to treat heart disease with prostheses that grow and regenerate. Now, researchers from the University of Zurich, the Technical University Eindhoven and the Charité Berlin have successfully implanted regenerative heart valves, designed with the aid of computer simulations, into sheep for the first time.

Producing living tissue or organs based on human cells is one of the main research fields in regenerative medicine. Tissue engineering, which involves growing...

Im Focus: Light-induced superconductivity under high pressure

A team of scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg investigated optically-induced superconductivity in the alkali-doped fulleride K3C60under high external pressures. This study allowed, on one hand, to uniquely assess the nature of the transient state as a superconducting phase. In addition, it unveiled the possibility to induce superconductivity in K3C60 at temperatures far above the -170 degrees Celsius hypothesized previously, and rather all the way to room temperature. The paper by Cantaluppi et al has been published in Nature Physics.

Unlike ordinary metals, superconductors have the unique capability of transporting electrical currents without any loss. Nowadays, their technological...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Save the date: Forum European Neuroscience – 07-11 July 2018 in Berlin, Germany

02.05.2018 | Event News

Invitation to the upcoming "Current Topics in Bioinformatics: Big Data in Genomics and Medicine"

13.04.2018 | Event News

Unique scope of UV LED technologies and applications presented in Berlin: ICULTA-2018

12.04.2018 | Event News

 
Latest News

Supersonic waves may help electronics beat the heat

18.05.2018 | Power and Electrical Engineering

Keeping a Close Eye on Ice Loss

18.05.2018 | Information Technology

CrowdWater: An App for Flood Research

18.05.2018 | Information Technology

VideoLinks
Science & Research
Overview of more VideoLinks >>>