TUESDAY, Nov. 27 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel on Wednesday urged that stronger label warnings focused on children be added to the packaging for Serevent and Advair, two widely used asthma drugs.

Both drugs are long-acting beta agonist medications containing salmeterol, and are used as asthma prevention in children and adults age 4 and up.

But last year -- after a 2005 panel investigation focused mainly on the drugs' use by adults -- the FDA added a strong "black box" warning on both medications that they "may increase the risk of asthma-related death."

The FDA's Pediatric Advisory Committee's new recommendation is that this warning be extended specifically to pediatric users of the two drugs, according to Marketwatch, and that it include mention of the fact that the drugs could boost the risk of asthma-linked hospitalizations.

Both drugs are made by GlaxoSmithKline, which said it believed the current 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 label change "an urgent public health issue," according to the Wall Street Journal.

"You need to move forward soon," she told the agency.

The announcement came after the same panel recommended on Tuesday that the prescription flu drug Tamiflu (oseltamivir) should have a stronger warning label to reflect reports of bizarre behaviors and deaths among children who use the medication.

On Wednesday, the drug's manufacturer, Roche, accepted the recommendation, the Associated Press reported.

The panel, in a 9-5 vote, said Roche should change the drug's 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 behaviors, AP reported.

A spokeswoman for Roche said Wednesday that all flu patients, not just those taking Tamiflu, should be warned that the illness posed a risk of psychiatric problems. She stressed there was no causal relationship between Tamiflu and the reported cases of delirium and hallucinations, AP reported.

In addition, the FDA panel recommended that labeling for the flu drug Relenza, (zanamivir), should also reflect reports of abnormal 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 flu 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, testified, 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.

GlaxoSmithKline, the maker of Relenza, also released a statement after the meeting. "GSK was pleased to have the opportunity to present safety information on Relenza to the Pediatric Advisory Committee showing no conclusive evidence of a causal association between Relenza and neuropsychiatric events," the statement said.

"We believe the current Relenza U.S. prescribing information accurately reflects the safety profile of the drug," the company added.

The FDA first began reviewing Tamiflu in 2005. 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.

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

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

More information

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

MONDAY, Dec. 3 (HealthDay News) -- Mention inhalers and most people think of asthma, but new research shows that inhalers could become infection-fighting, lifesaving gear for firemen, emergency workers and other first responders.

They could also help protect people whose immune systems are weakened by chemotherapy or HIV, according to scientists who've tested the new inhaler in mice.

"We showed we can protect mice against all four major classes of pathogens: Gram positive bacteria, Gram negative bacteria, fungus and virus. So, it has protected against everything we tried," said study author Brenton Scott, a post-doctoral fellow in the pulmonary medicine department of the University of Texas M.D. Anderson Cancer Center.

His team was slated to present its findings Monday at the American Society for Cell Biology's annual meeting in Washington, D.C.

Pneumonia, especially, is a significant cause of death for chemotherapy patients, so the researchers decided to see if they could protect patients against the disease by boosting immune activity in the lungs beforehand.

The team exposed mice to an aerosolized formulation called Aerosolized Lung Innate Immune Stimulant (ALIIS), a soluble bacterial extract.

They then challenged the mice with inhaled Streptococcus pneumoniae, the pathogen that causes pneumonia.

The untreated mice all died of the infection, but 83 percent of the mice that were exposed two hours following treatment survived, as did 100 percent of mice exposed between four and 24 hours later. Protection lasted as long as five days, the team said, and was also effective against a broad range of pathogens, including the bacteria responsible for anthrax, plague, tularemia, the fungus Aspergillus and influenza virus.

According to Scott, this broad-spectrum protection means ALIIS could potentially be used by first responders in the event of a bioterror attack.

"First responders could potentially take a dose of ALIIS and be protected without knowing what the bugs are, and buy a window of opportunity to see what bacteria are out there," said Scott, who envisions a delivery system akin to an asthma inhaler.

But Steven Mizel, a professor of microbiology and immunology at Wake Forest University Health Sciences in Winston-Salem, NC, was skeptical.

"If first responders get a cut on their finger, they are still dead," he said.

That's because the protection afforded by ALIIS is limited to inhaled pathogens; challenge with injected bacteria still resulted in death, Scott noted. But Scott believes this finding is also a benefit, as it suggests the drug induces only a localized immune response, rather than a potentially damaging, whole-body one.

Scott also noted that ALIIS neither induced mucus formation not exacerbated asthma, and that repeated exposure of mice to the treatment appeared to cause little long-term damage beyond fibrosis, a thickening of the airways.

ALIIS induces massive stimulation of the so-called innate immune response, a hodge-podge of antimicrobial peptides (proteins), growth factors, and white blood cells that collectively, though non-specifically, deal with potential pathogens. Indeed, it does this so well, Scott said, that microbes died virtually on contact with the lining of the airway.

But ALIIS has no effect on the other arm of immunity, the adaptive response of B and T lymphocytes that are responsible for protective antibodies and long-term immunological memory. As a result, Mizel said, its potential real-world efficacy could be limited.

"I think this research supports the contention that the innate immune response is being triggered, and that is a good holding action," Mizel said. But he added that, "you need adaptive immunity to kick in eventually," especially if the body is exposed to large doses of pathogen, as is likely during a bioterror incident.

"If you are at the epicenter of the attack, and there are high concentrations of bacteria around, I would be shocked if the innate immune system could handle that," he said.

Study senior author Dr. Burton Dickey and Scott have formed a company called Pulmotect to commercialize ALIIS. Clinical trials are in the planning stages, Scott said, but will have to wait at least until safety and efficacy studies in other animal models can be completed.

More information

For more information on infectious disease, visit the U.S. Centers for Disease Control and Prevention.

SATURDAY, Dec. 1 (HealthDay News) -- It's easy for the holidays to become the season of sneezing, congestion and other woes for people with food or other allergies and asthma, say experts at the American Academy of Allergy, Asthma & Immunology (AAAAI).

But some preventive measures can cut symptoms to a minimum, they say.

"Whether it's feasting on holiday meals, setting up your Christmas tree, or visiting your pet-owning relatives, allergy triggers may be lurking inside of our warm, cozy homes this time of year," Alisa M. Smith, vice-chairwoman of the AAAAI's indoor allergen committee, said in a prepared statement. "Unfortunately, with busy schedules, travel time and the stress of the holidays, it is easy to forget to take the proper care when dealing with allergies and asthma. However, avoiding potential triggers and taking the proper precautions is necessary to keep symptoms under control."

The AAAAI offers the following tips for people with asthma and different types of allergies:

• When you're at parties or family gatherings, inform your hosts about your food allergy and ask about the ingredients used to prepare the meal.
• Always carry an injectable dose of epinephrine. Homemade meals/snacks don't have ingredient lists and may be contaminated with trace of amounts of allergenic foods through contact with storage containers or kitchen utensils.
• Remind family and friends that strict avoidance is the only way for you to manage food allergies and that even a tiny bit of allergenic foods can trigger a dangerous allergic reaction.
• If you're visiting homes where there are pets, take your allergy medication beforehand.
• Real Christmas trees often carry microscopic mold spores that can cause allergic symptoms such as sneezing, water eyes, and an itchy nose.
• Decorations and artificial trees can gather mold and dust while in storage. Clean them before you start putting them up.
• Artificial snow can irritate your lungs if you inhale it. Be sure to follow directions when spraying artificial snow on windows or other surfaces.
• The stress of the holiday season can sometimes trigger an asthma attack. Monitor your stress levels. If you do feel stressed, deep breathing and relaxation may help.
• If you're sleeping away from home, bring your own pillow with an allergen-proof cover. Ask for down-free pillows.
• Avoid wood smoke, which can trigger an asthma attack.

More information

The American Academy of Family Physicians has more about controlling allergy symptoms  .