FDA Panel Backs Tougher Warning on Asthma Drugs for Kids

FDA Panel Backs Tougher Warning on Asthma Drugs for Kids
TUESDAY, Nov. 27 (HealthDay News) -- A U.S. Food and DrugAdministration advisory panel on Wednesday urged that stronger labelwarnings focused on children be added to the packaging for Serevent andAdvair, two widely used asthma drugs.
Both drugs are long-acting beta agonist medications containingsalmeterol, and are used as asthma prevention in children and adults age 4and up.
But last year -- after a 2005 panel investigation focused mainly on thedrugs' use by adults -- the FDA added a strong "black box" warning on bothmedications that they "may increase the risk of asthma-related death."
The FDA's Pediatric Advisory Committee's new recommendation is thatthis warning be extended specifically to pediatric users of the two drugs,according to Marketwatch, and that it include mention of the factthat the drugs could boost the risk of asthma-linked hospitalizations.
Both drugs are made by GlaxoSmithKline, which said it believed thecurrent black-box warning was sufficient, according to Marketwatch.The FDA says it also plans a new safety review of the two drugs.
Marsha Rappley, chair of the panel, called the recommended labelchange "an urgent public health issue," according to the Wall StreetJournal.
"You need to move forward soon," she told the agency.
The announcement came after the same panel recommended on Tuesday thatthe prescription flu drug Tamiflu (oseltamivir) should have a strongerwarning label to reflect reports of bizarre behaviors and deaths amongchildren who use the medication.
On Wednesday, the drug's manufacturer, Roche, accepted therecommendation, the Associated Press reported.
The panel, in a 9-5 vote, said Roche should change the drug'sprescribing information because it doesn't adequately explain side effectsreported by hundreds of patients in Japan and the United States, accordingto Bloomberg News.
The drug's label mentions reports of delirium and self-injury,primarily among children in Japan, but the advisory panel said thelanguage should state that several patients died as a result of thesebehaviors, AP reported.
A spokeswoman for Roche said Wednesday that all flu patients, not justthose taking Tamiflu, should be warned that the illness posed a risk ofpsychiatric problems. She stressed there was no causal relationshipbetween Tamiflu and the reported cases of delirium and hallucinations,AP reported.
In addition, the FDA panel recommended that labeling for the flu drugRelenza, (zanamivir), should also reflect reports of abnormal behavior,according to Bloomberg.
The FDA is not obliged to follow its expert panels' recommendation, butit usually does. A safety review released Friday by the FDA's Division ofAntiviral Products urged stronger label warnings for both flu drugs,including stricter monitoring of children taking these drugs.
According to the FDA safety review, there have been 596 reported casesof psychiatric behavior associated with Tamiflu use. Most of these caseshappened among patients aged 21 or younger. The majority (75 percent)occurred in Japan.
Fifty-nine of the cases were classified as delirium with impulsivebehavior and self-injury. Delirium, delusions, hallucinations or psychosisaccounted for another 225 cases. In total, five children died "as a resultof falls from windows or balconies or running into traffic," the safetyreview found, and three adults committed suicide. So far, there haven'tbeen any such cases reported in the United States, according to theFDA.
The FDA safety review also reported that in cases involving Relenza,mostly in Japan, there have been 115 reports of "delirium with impulsivebehavior and self-injury in which the patient expressed 'fear' andattempted to flee or expressed a desire to 'jump,'" the agency said. Therewere no deaths associated with Relenza.
During its meeting on Tuesday, the advisory panel said it was unclearwhether the psychiatric problems are a side effect of Tamiflu or the fluitself, AP reported.
At the hearing, representatives of Roche told the panelists that theflu itself, not Tamiflu, caused the bizarre behaviors.
"We feel that the current U.S. prescribing information is an accurateassessment of the current data," Jonathan Solsky, Roche's director of drugsafety risk management, testified, according to Bloomberg.
In a statement released after the meeting, Roche reiterated its faithin the drug. "According to data analyzed from two U.S. claims databases ofmore than 150,000 patients, there is no increased risk forneuropsychiatric events in influenza patients treated with Tamiflucompared to untreated influenza patients," the statement said.
GlaxoSmithKline, the maker of Relenza, also released a statement afterthe meeting. "GSK was pleased to have the opportunity to present safetyinformation on Relenza to the Pediatric Advisory Committee showing noconclusive evidence of a causal association between Relenza andneuropsychiatric events," the statement said.
"We believe the current Relenza U.S. prescribing information accuratelyreflects the safety profile of the drug," the company added.
The FDA first began reviewing Tamiflu in 2005. Since November 2006, thedrug's label has had a warning focused on self-injury and delirium,advising that patients be monitored during treatment. In March, theJapanese Ministry of Health, Labor and Welfare limited Tamiflu use inpatients aged 10 to 19 years old.
Tamiflu is approved both as a preventative and a treatment for flu foradults and children aged 1 year and older.
Relenza is approved as both a flu preventative and a treatment inadults and children aged 5 years old and older.