Kids' drugs under FDA spotlight

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NEW YORK (CNNMoney.com) -- FDA panelists this week will scrutinize the safety of certain drugs approved for children - including anti-viral and anti-asthma drugs from Glaxo, Roche and Novartis - in meetings that could have wider implications for the industry.

Advisers for the Food and Drug Administration will meet Tuesday through Thursday in Gaithersburg, Md., as part of an ongoing safety study on various drugs used primarily by adults but also approved for children.

The meetings are unlikely to have any immediate impact on the companies' financial performance, analysts said. But they could lead to more restrictive labels, and make it more difficult for drugmakers to get their products approved for children, said Les Funtleyder, analyst for Miller Tabak.

"I suspect that the rules will ultimately get tighter, not looser," said Funtleyder. He said the FDA meetings probably won't have an immediate affect on drug sales, but "it does auger poorly for pediatric extensions."

Tamiflu, the influenza anti-viral produced by the Swiss drug giant Roche, will command most of the attention, following a spate of safety issues in Japan, including the deaths of eight children. Roche did not divulge how much of its sales come from children, but said that pediatric use of Tamiflu in Japan is sixfold that of the U.S.

The FDA said, in documents published on its site, that Tamiflu "has been associated with postmarketing reports of abnormal and self-injurious behavior including reports of deaths in Japanese teenagers from traumatic injuries (e.g. jumping from buildings.)"

FDA experts will focus on reports of neuropsychiatric problems such as hallucinations. This side effect has also been linked to British drugmaker GlaxoSmithKline's (Charts) Relenza, an influenza anti-viral that is a member of the same drug class as Tamiflu, called neuraminidase inhibitors.

Documents from the FDA, and from Glaxo and Roche, said these drugs had not been proven to cause the hallucinations. But the FDA suggested that these "adverse events" be mentioned in the "precaution" section of the drugs' labels.

Roche said, in a statement to CNNMoney.com, that it was "open" to a label change if the FDA requests it. But the company also said that "reports of neuropsychiatic events are infrequent" and Tamiflu isn't the proven cause.

Roche said, based on its analysis of available data, "there is no increased risk for neuropsychiatric events in influenza patients treated with Tamiflu compared to untreated influenza patients."

The meeting will also focus on pediatric use of Glaxo's Serevent and Advair, as well as Foradil from Novartis (Charts) and Schering-Plough (Charts, Fortune 500), which are inhalable treatments for asthma and other breathing conditions. Serevent and Advair contain salmetrol, an ingredient that has raised concern about possible side effects.

Back in 2003, the FDA released a safety alert for Serevent and said that salmetrol "may increase the risk of asthma-related death." But the FDA also said respiratory events were "rare," and the agency still granted pediatric use of the drug in 2006. The FDA described the market for salmetrol as "small" and "declining."

The industry for pediatric drugs is probably a multi-billion-dollar market. But IMS Health, and analysts who were interviewed for this story, said it was difficult, if not impossible, to quantify just how big it is.