Navigation Links
Common chemotherapy drug triggers fatal allergic reactions

CHICAGO -- A chemotherapy drug that is supposed to help save cancer patients' lives, instead resulted in life-threatening and sometimes fatal allergic reactions.

A new study from the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program at Northwestern University Feinberg School of Medicine identified 287 unique cases of hypersensitivity reactions submitted to the FDA's Adverse Event Report System between 1997 and 2007 with 109 (38 percent) deaths in patients who received Cremophor-based paclitaxel, a solvent-administered taxane chemotherapy.

Adverse event reports generally only represent from 1 to 10 percent of actual incidence, so the number of hypersensitivity reactions and deaths is likely significantly higher. The severe allergic reactions are believed to be caused by Cremophor, the chemical solvent - a derivative of castor oil -- that is used to dissolve some insoluble drugs before they can be injected into the blood stream.

Two patients who died from an allergic reaction had early-stage breast cancer, which had been surgically removed, and were being treated with Cremophor-containing paclitaxel to prevent the cancer from coming back. Both of these patients had received medications before the chemotherapy to reduce the risk of hypersensitivity reactions.

The study was led by Charles Bennett, M.D., RADAR program coordinator and a professor of hematology/oncology at Northwestern's Feinberg School, and Dennis Raisch, a professor of pharmacy at the University of New Mexico.

"The deaths of women with early-stage breast cancer are particularly disturbing because without the adverse reaction, they could have likely had 40 years of life ahead of them," Bennett said.

RADAR investigators also found that 22 percent of all fatalities occurred in patients despite patients having received premedication to prevent hypersensitivity reactions, while another 15 percent of such patients experienced life-threatening respiratory arrest.

The report was presented at the 45th Annual Meeting of the American Society of Clinical Oncology held recently in Orlando, Fla.

Cremophor-containing paclitaxel has been associated with hypersensitivity reactions, with responses ranging from mild skin conditions to more severe effects, including anaphylaxis and cardiac collapse. Current U.S. product labeling for Cremophor containing paclitaxel includes a black-box warning alerting physicians and patients of potential toxicity and recommending the use of corticosteroids and other medications before chemotherapy administration to reduce the risk of hypersensitivity reactions.

"The results of our review suggest that physicians should be vigilant in monitoring the safety of their patients undergoing chemotherapy treatment," said Bennett, who also is the A.C. Buehler Professor in Economics and Aging at the Feinberg School and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

"Patients receiving Cremophor-based paclitaxel should be given medications to prevent hypersensitivity reactions, but what is sobering, as the study has shown and as the black-box warning indicates, women suffer anaphylaxis despite receiving steroid premedication," Bennett said. "Physicians should be diligent in reporting adverse events to regulatory agencies to better monitor the impact of Cremophor on patient safety. Physicians may also want to consider exploring other alternative chemotherapy options that do not include Cremophor."

In addition to the two women with early-stage breast cancer who died after treatment with the Cremophor-based paclitaxel, four other women with early-stage breast cancer experienced life-threatening anaphylaxis reactions. Each of them had received prior medications to prevent the reactions.

"The fatal outcomes observed in patients with early-stage breast cancer were particularly striking as this is a patient population with a good prognosis that is generally treated with curative intent," said Raisch.

For the report, Bennett and Raisch reviewed adverse event reports submitted to regulatory agencies in the U.S., Europe and Japan. The most common cancer diagnosis for these patients with allergic reactions was lung cancer followed by breast cancer and ovarian cancer.


Contact: Marla Paul
Northwestern University

Related biology news :

1. Low levels of vitamin D linked to common vaginal infection in pregnant women
2. UNC study identifies genetic cause of most common form of breast cancer
3. Poor treatment for common vertebral compression fractures
4. Common fragrance ingredients in shampoos and conditioners are frequent causes of eczema
5. Psychiatric disorders are common in adults who have had anorexia
6. Gene exchange common among sex-manipulating bacteria
7. Common gene variants influence risk factor for sudden cardiac death
8. Catching the common cold virus genome
9. Computer superpower strengthens attempts to combat common diseases
10. Common gene variants increase risk of hypertension, may lead to new therapies
11. New vaccine developed for preventing uncommon cold virus
Post Your Comments:
(Date:11/9/2015)... Nov. 9, 2015  Synaptics Inc. (NASDAQ: SYNA ... announced broader entry into the automotive market with a ... the pace of consumer electronics human interface innovation. Synaptics, ... ideal for the automotive industry and will be implemented ... Europe , Japan , ...
(Date:10/29/2015)... RESTON, Va. , Oct. 29, 2015 ... announced today that it has released a new version ... Daon customers in North America ... gains. IdentityX v4.0 also includes a FIDO UAF ... customers are already preparing to activate FIDO features. These ...
(Date:10/27/2015)... In the present market scenario, security is ... industry verticals such as banking, healthcare, defense, electronic gadgets, ... for secure & simplified access control and growing rate ... of bank accounts, misuse of users, , and so ... laptops, and smartphones are expected to provide potential opportunities ...
Breaking Biology News(10 mins):
(Date:12/1/2015)... ADDISON, Texas (PRWEB) , ... ... ... International , a leading relationship marketing company specializing in scientifically backed, age-defying ... magazine’s January 2016 issue, which highlights the exponential success and unrivaled opportunities ...
(Date:12/1/2015)... -- Cepheid (Nasdaq: CPHD ) today announced that, ... Healthcare Conference in New York City ... outlook for the fourth quarter of 2015 and initiating ... term business model expectations. John Bishop , ... be the fastest growing company of the major market ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... meeting this month and Dr. J. Kyle Mathews will join fellow ... the new single site hysterectomy. , An experienced urogynecologist, founder of Plano Urogynecology ...
(Date:12/1/2015)... , December 1, 2015 ... of the  "2016 U.K. Virology and Bacteriology ... for 100 Tests, Supplier Shares by Test, ... to their offering.  --> ... "2016 U.K. Virology and Bacteriology Testing Market: ...
Breaking Biology Technology: