Navigation Links
FDA Panel Backs Stronger Warning for Tamiflu
Date:11/27/2007

Advisers say current labeling doesn't reflect reports of bizarre behaviors and sudden deaths

TUESDAY, Nov. 27 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Tuesday that the prescription flu drug Tamiflu (oseltamivir) should have a strengthened warning label to reflect reports of bizarre behaviors and deaths among children.

The FDA's Pediatric Advisory Committee, in a 9-5 vote, said that drug maker Roche Holding AG should change its current prescribing information because it doesn't adequately explain side effects reported by hundreds of patients in Japan and the United States, according to Bloomberg News.

The drug's label mentions reports of delirium and self-injury, primarily among children in Japan, but the advisory panel said the language should state that several patients died as a result of these abnormal behaviors, the Associated Press reported.

In addition, the panel recommended that labeling for the flu drug Relenza, (zanamivir), should also reflect reports of bizarre behavior, according to Bloomberg.

The FDA is not obliged to follow its expert panels' recommendation, but it usually does. A safety review released Friday by the FDA's Division of Antiviral Products urged stronger label warnings for both drugs, including stricter monitoring of children taking these drugs.

According to the FDA safety review, there have been 596 reported cases of psychiatric behavior associated with Tamiflu use. Most of these cases happened among patients aged 21 or younger. The majority (75 percent) occurred in Japan.

Fifty-nine of the cases were classified as delirium with impulsive behavior and self-injury. Delirium, delusions, hallucinations or psychosis accounted for another 225 cases. In total, five children died "as a result of falls from windows or balconies or running into traffic," the safety review found, and three adults committed suicide. So far, there haven't been any such cases reported in the United States, according to the FDA.

The FDA safety review also reported that in cases involving Relenza, mostly in Japan, there have been 115 reports of "delirium with impulsive behavior and self-injury in which the patient expressed 'fear' and attempted to flee or expressed a desire to 'jump,'" the agency said. There were no deaths associated with Relenza.

During its meeting on Tuesday, the advisory panel said it was unclear whether the psychiatric problems are a side effect of Tamiflu or the flu itself, AP reported.

At the hearing, representatives of Roche told the panelists that the flu itself, not Tamiflu, caused the bizarre behaviors.

"We feel that the current U.S. prescribing information is an accurate assessment of the current data," Jonathan Solsky, Roche's director of drug-safety risk management, said according to Bloomberg.

In a statement released after the meeting, Roche reiterated its faith in the drug. "According to data analyzed from two U.S. claims databases of more than 150,000 patients, there is no increased risk for neuropsychiatric events in influenza patients treated with Tamiflu compared to untreated influenza patients," the statement said.

The FDA first began reviewing Tamiflu in 2005, and, since November 2006, the drug's label has had a warning focused on self-injury and delirium, advising that patients be monitored during treatment. In March, the Japanese Ministry of Health, Labor and Welfare limited Tamiflu use in patients aged 10 to 19 years old.

One expert believes a new warning is appropriate for Tamiflu. "The idea that there have been 596 neuropsychiatric events is a reason for the FDA to put a strong warning on the label," said Dr. Marc Siegel, a clinical associate professor of medicine at New York University School of Medicine in New York City.

But he is also concerned that the public might overreact.

"I am not a fan of replacing fear of a disease with fear of the treatment for the disease," said Siegel, speaking before the advisory panel met. "You don't need to go from one panic to another."

Tamiflu is overused, however, Siegel added. "It's supposed to be used in a very narrow window, and I am not surprised that there have been psychiatric side effects related to this drug," he said. "Maybe the new warning will lead to less overuse."

Tamiflu is approved both as a preventive and a treatment for flu for adults and children aged 1 year and older.

Relenza is approved as both a flu preventive and a treatment in adults and children aged 5 years old and older.

GlaxoSmithKline, the British maker of Relenza, doesn't believe the label needs changing. "The review and analysis of all the information available in this safety summary of neuropsychiatric events does not implicate or indicate a significant causal role of zanamivir. Therefore, no revisions are warranted for the U.S. Prescribing Information and the FDA-approved Patient Labeling for Relenza," the company told the FDA.

More information

For more on flu, visit the U.S. Centers for Disease Control and Prevention.



SOURCES: Marc Siegel, M.D., clinical associate professor, medicine, New York University School of Medicine, New York City; Pediatric Safety Update for Tamiflu, Division of Antiviral Products, U.S. Food and Drug Administration; statements, GlaxoSmithKline and Hoffmann-La Roche Inc.; Bloomberg news; Associated Press


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
2. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
3. Patient Safety Authority Board of Directors Names Infection Advisory Panel
4. Partners Rx Chief Pharmacy Officer, Richard Bullard on Panel Discussion at the Fall 2007 Managed Markets Summit (MMS) in Phoenix, AZ.
5. Billians HealthDATA GM Speaking on Dreamforce 07 Panel
6. FDA Panel Recommends Approval of SyntheMeds REPEL-CV(R) Adhesion Barrier for Pediatric Patients
7. Abaxis Announces New Waived Kidney Check Panel Exclusively for Imaging and Radiology Centers
8. Health Courts Critic to be Featured Speaker at Wyoming Patient Safety Panel
9. FDA Panel Mulls Ban on Kids Cold Medicines
10. FDA Panel Weighs Ban on Kids Cold Medicines
11. FDA Panel Recommends Ban on Cold Medicines for Kids
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel Backs Stronger Warning for Tamiflu
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... PurhealthRX ... CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will ... and providing a CBD form that can be easily incorporated into liquid products, while ...
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & ... and special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to ... with elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance ... care insurance companies have a waiver for care if the client has a cognitive ... the family pays for care, is often waived, so the benefits from their insurance ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional ... action towards gender equality at their inaugural Summit in New York City in June. ... a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Yisrayl Hawkins, Pastor ... that explains one of the most popular and least understood books in the Holy ... and puzzling descriptions that have baffled scholars for centuries. Many have tossed it off ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... 10, 2017   West Pharmaceutical Services, Inc. ... injectable drug administration, today shared the results of a ... improving the intradermal administration of polio vaccines. The study ... in May 2017 by Dr. Ondrej Mach , ... Health Organization (WHO), and recently published in the journal ...
(Date:10/4/2017)... OBP Medical , a leading ... today announced regulatory approval from Brazil,s ... Nacional de Vigilância Sanitária (ANVISA)) to market ... with integrated LED light source and smoke evacuation ... of a tissue pocket or cavity during surgical ...
(Date:10/2/2017)... The Rebound mobile app is poised to become a vital ... prescription drug addiction. The app empowers users to develop an ... their dosage in a safe, controlled manner while maximizing well-being. ... 100,000 people to sign up will enjoy 3 months of ... ...
Breaking Medicine Technology: