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FDA to Vote “Up, or Down” on Foradil, and other LABAs — Tomorrow.


UPDATED From Reuters — 12.11.08 @ 3:30 PM EST: “. . . .ROCKVILLE, Md., Dec 11 (Reuters) – Two asthma drugs, GlaxoSmithKline PLC’s Serevent and [US Schering’s] Foradil, pose serious risks that outweigh their benefits for treating adults, adolescents and children, a U.S. advisory panel ruled on Thursday. . . .”

This means that the FDA panel has recommended that Foradil not be prescribed for asthma, at all (regardless of patient age) — and that Foradil only retain its FDA-approval for treating COPD — a much narrower market, in the US. In any event, additional warnings, beyond the existing “black-box” language will now go on Foradil’s pacakging.

Ouch.

[Item Originally Posted 12.10.08 5:03 PM EST] Reuters has today’s FDA review panel summary-story — as to US Schering’s Foradil — and the staffers’ remarks from Rockville, Maryland, at the Hilton:

. . . .Reviewers in the FDA’s drug safety office have recommended revoking the medicines’ approval for treating asthma in children, according to documents prepared for the panel.

The reviewers also said Serevent and Foradil, which are used much less often, should not be taken by anyone with asthma.

The FDA is undecided on how to proceed and is seeking input from the panel of outside experts. . . .

Vote results to be provided, here, tomorrow. Should be interesting. As I’ve earlier guessed, I think Foradil will earn an FDA “split decision” — it will likely remain on the market, but no-longer be indicated for pediatric use. UPDATE: To be clear, no one is suggesting that it be pulled for COPD. I think FDA is clear that LABAs do offer some positive risk-to-efficacy ratio, as to COPD.

Yikes! Motley Fool Echoes My Views on Schering’s Foradil, at FDA Review Panel, Tomorrow. . . .


I am not entirely certain that I should be linking his, here, as “the Fool” is more-than-occasionally, um. . . just that, as to matters financial, but he does come out where I did, last week (12.05.08), about tomorrow’s 8:00 AM EST FDA Review Panel, at the Hilton, in Rockville, Maryland.

Before we read his pull-quote, let me offer an FDA link to all reported Foradil “adverse events, sorted by events involving patients less than 17 years of age — “The truth will set you free!” — now, do go read his whole note, but here is his Schering punch-line:

. . . .There’s also the possibility of removing Serevent and Foradil from the market altogether. Those two drugs only contain LABAs, while Advair and Symbicort have a steroid added to the mix. Glaxo argues that pulling the LABA-only drugs is unnecessary because they’re already co-prescribed with a steroid. . . .

We’ll know in about 28 hours.