Navigation Links
Warning on Avastin Updated

A new label change has been proposed by the FDA for the anti-angiogenic colorectal-cancer drug Avastin (bevacizumab) to include rare cases of a reversible posterior leukoencephalopathy syndrome in its warning.//

Genentech, which markets Avastin said that the brain-capillary leak syndrome has been reported or confirmed in less than 0.1% of the estimated 60,000 cancer patients treated with Avastin.

The Adverse Reactions and Dosage and Administration sections of the Avastin label have been updated to include the warning about reversible posterior leukoencephalopathy as well as nasal septum perforation.

Genentech reported seven cases of nasal septum perforation reported in post market surveillance.

Reversible posterior leukoencephalopathy syndrome is also associated with fluid retention, hypertension and the cytotoxic effects of the immunosuppressive drugs on the vascular endothelium.

J. Leonard Lichtenfeld, M.D., deputy medical director of the American Cancer Society in Atlanta, said this not the first time that the anti-angiogenic agent has been linked with bleeding problems. He noted, for example, the perforated colon has been reported in Avastin colorectal cancer studies.

Dr. Lichtenfeld said, "This is exactly the reason that post marketing surveillance is so important for all drugs and especially for chemotherapy drugs."

According to him Avastin is "typically is given to patients with advanced disease and aggressive tumors," a patient population that is compromised by disease and thus at higher risk for side-effects.

Genetech letter’s to the clinicians said that reversible posterior leukoencephalopathy usually presents with "headache, seizure, visual disturbance, and altered mental function, and is characterized by reversibility upon control of hypertension or other instigating factors," with onset of symptoms reported to occur within 16 hours to one year of initiation of Avastin treat ment.

Magnetic resonance imaging studies are needed to confirm diagnosis.

Patients who develop symptoms of reversible posterior leukoencephalopathy should discontinue Avastin and initiate hypertension treatment, if necessary.

Genetech also says that symptoms "usually resolve or improve within days, although some patients have experienced ongoing neurologic sequelae." It is still unknown however whether Avastin can safely be reinitiated in patients who developed reversible posterior leukoencephalopathy syndrome.


NLA
'"/>




Related medicine news :

1. Early Warning System For Breast Cancer
2. Warning on radiowave exposure
3. A Seizure Late In Life Could be A Stroke Warning
4. Blood Pressure An Early Warning Sign Of Alzheimer’s Disease
5. Early Warning Signs Of Heart Disease
6. Warning Issued by FDA on consumption of the drug Tysabri used to treat Multiple Sclerosis
7. Warning issued by FDA over "Liqiang 4 Capsules"
8. Warning Signs On Powered Baby Milk
9. People Still Neglect To Use Sunscreen In Spite Of Cancer Warnings
10. Global Outbreak Of Bird Flu Warning By Chinese Scientist
11. Experts Building Bird Flu Warning System
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:2/13/2016)... City, Utah (PRWEB) , ... February 13, 2016 , ... When an Au Pair ... Parents aren’t always sure what they are in for and they are often worried things ... more than they were hoping for. This year’s Au Pair of the Year winner’s all ...
(Date:2/12/2016)... San Antonio, TX (PRWEB) , ... February 12, 2016 , ... ... of love, as expressed in Blue SKies Buddha, the biography of Rama - Dr. ... in fact a love story, the love of a Buddhist teacher for teaching and ...
(Date:2/12/2016)... ... ... Trends: , Back to the Future , Feb. 25, 2016 — 11:00 a.m. – 12:30 ... don’t learn from history are doomed to repeat it.” , An analysis of CDRH’s enforcement ... that takes time. , Take a close look at the warning letters the agency ...
(Date:2/12/2016)... ... ... Coco Libre, the maker of coconut water beverages with a purpose, is ... Coco Libre will offer musicians and celebrities the company’s signature Organic Coconut Water, a ... suite, held this year at the W Hollywood Hotel, has become a pre-show “must” ...
(Date:2/12/2016)... ... , ... Every winter, someone is killed, injured or loses a home in ... part of the Allegheny Health Network, has partnered with Etna Volunteer Fire Department, ... Space” campaign. , “Space Heaters Need Space” aims to bring awareness to ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... Feb. 12, 2016 /PRNewswire/ - Demers Ambulances announces its first delivery ... Okaloosa County Emergency Medical Services (EMS) ... and one LT2 van. Quality Emergency Vehicles in ... for the sale.  This is the latest in Demers, ongoing ... Vice President at Demers. --> Benoit LaFortune , ...
(Date:2/12/2016)... ALISO VIEJO , Kalifornien, 12. Februar 2016 ... es mit der Aufnahme von Patienten für eine ... Embolisation von Aneurysmen („WEB") speziell für die Behandlung ... Laurent Spelle , MD, Leiter der Neuroradiologie an ... , Frankreich, und Hauptprüfarzt der CLARYS-Studie hat den ...
(Date:2/12/2016)... and SEOUL, South Korea , ... and Macrogen, Inc. today announced they will form ... procedures for precision medicine in cancer. The goal ... DEPArray™ digital-sorting technology with Macrogen,s high-throughput Next Generation ... under the Clinical Laboratory Improvement Amendments (CLIA) of ...
Breaking Medicine Technology: