That’s what an FDA panel recommended this afternoon for Advair and Serevent, which both contain the same active ingredient. The advisory committee also urged the agency to move quickly with another safety review of the drugs - including Foradil, a Novartis med that’s sold in the US by Schering-Plough - after one panel member questioned safe use in children. The drugs are used for long-term prevention of asthma in kids and adults.

“It’s an urgent public health issue. You need to move forward soon,” Marsha Rappley, chairwoman of the FDA’s pediatric advisory committee and dean of Michigan State University’s College of Human Medicine, told FDA staffers at the meeting, according to The Wall Street Journal.

This isn’t the first time the drugs have been scrutinized over safety concerns. Last year, the FDA placed a Black Box warning on Serevent and Advair because they “may increase the risk of asthma-related death,” although the warning came after a 2005 advisory committee meeting that mostly focused on adult use of the products, the Journal reminds us. A similar warning also applies to Foradil.

Today, however, the FDA panel decided the warning on Serevent and Advair needs to be more specific to children and that it should also include language that the drugs increase the risk of asthma-related hospitalizations. The panel, which didn’t hold a formal vote, also said there should be more prominent language telling patients and doc that the meds should be used in combo with other drugs designed to control acute asthma attacks, but shouldn’t be used alone, the Journal writes.

Dianne Murphy, the director of FDA’s office of pediatric therapeutics, said the agency would consider adding new warning language to the labels while it conducts the more in depth safety review of the asthma drugs in children. “Right now we don’t think it’s appropriate to take the drugs off the market” or restrict use to adults only, she said, according to the Journal.

In a statement, Glaxo says the meds are labeled appropriately, but will talk, of course, with the FDA about the panel’s advice. “There is no new safety information safety information that changes the benefit-risk evaluation of Serevent or Advair which warrants another review at this time,” says Glaxo, which adds that safety monitoring will continue, while noting ashtma-related deaths in the US have declined 29 percent since the meds became available in the mid- 1990’s, citing CDC data. Glaxo “has confidence in the established safety profile of Advair and Serevent when these products are used according to their labels, which are consistent with recently issued national treatment guidelines.”

Andrew Mosholder, a medical officer in FDA’s drug risk division, said the overall numbers of serious adverse events and deaths possibly linked to the drugs are low and noted that the adverse-event reports themselves do not mean the drugs caused a problem. But, he said, there is also no basis to believe that the increased risk of death and asthma exacerbations seen in adults wouldn’t also apply to children. “This raises the question of what clinical benefits would justify exposure to these risks,” he said in a presentation to the FDA panel, the Journal reports.

While clinical studies have showed all three drugs are successful at controlling asthma in the vast majority of patients, some have shown that salmeterol can cause severe - and sometimes fatal - asthma attacks in a small group of patients. Asthma is a chronic disease that causes narrowing of the airways and affects 22 million Americans, including about 6.5 million children, according to the paper.

The FDA looked at adverse-safety events associated with Serevent and Advair from March 9, 2006, through April 9, 2007, as part of a routine safety review of drugs approved for use in children. The review found nine adverse-event reports in children and five deaths during its 13-month review period of Serevent.

A review of pediatric deaths possibly associated with Serevent from 1994 through 2007 showed 23 deaths, the FDA said, with 14 of the cases being reported as being caused by asthma exacerbation or a worsening of the condition. The agency noted that some patients will experience asthma exacerbations even when receiving appropriate therapy. A review of deaths possibly linked to Advair showed 15 pediatric deaths from 1999 through 2007.

National treatment guidelines recommend low-dose, inhaled corticosteroids for routine management of the disease along with an inhaler, or so-called rescue medication, to manage attacks. The guidelines recommend that drugs like Serevent, Advair and Foradil should be used only as add-on therapy in patients 12 and older whose asthma isn’t controlled by corticosteroids, the Journal writes.