[SSRI-Research] Forest Labs Falls on Drug Query [Celexa/Lexapro]

[Guest guest]

> JustSayNo

> Thu, 1 Jul 2004 23:41:27 -0400

> [sSRI-Research] Forest Labs Falls on Drug

> Query [Celexa/Lexapro]

>

> Eric Gillin

> Forest Labs Falls on Drug Query

> By Eric Gillin

> TheStreet.com Staff Reporter

> 6/30/2004 2:10 PM EDT

> URL: http://www.thestreet.com/markets/ericgillin/10168688.html

>

> Forest Laboratories (FRX:NYSE) shares continued

> their slump Wednesday, hitting a seven-month low

> after the company received a request from the New

> York State Attorney General for information

> concerning off-label clinical trials for its

> products.

>

> The news is the latest in Eliot Spitzer's ongoing

> investigation into whether drugmakers are secretly

> burying negative clinical studies to promote a rosy

> worldview to investors. Three weeks ago, the

> Attorney General sued GlaxoSmithKline (GSK:NYSE) ,

> alleging the company spiked negative studies about

> the effect of the antidepressant Paxil on children.

>

> In reaction, Forest said it will fully cooperate

> with the request, stressing it was not a subpoena,

> and said it believes it has complied with all

> applicable laws. But shares of the company fell

> $1.55, or 2.7%, to $56.10, hitting $54.97 early in

> the session, a low the shares hadn't seen since Dec.

> 7.

>

> Forest has been on the defensive lately, coming

> under increasing scrutiny by the Food and Drug

> Administration for not publishing data from clinical

> trials of its depressants, especially with regards

> to claims that its antidepressants increase the risk

> of suicide in young patients.

>

> Recently, a pair of European studies -- neither of

> which was touted by Forest -- seemed to suggest that

> its antidepressant Celexa had a greater risk for

> younger patients than was previously thought. To

> help assuage fears it was hiding something, last

> Friday Forest sent out a press release reviewing the

> results of trials on Celexa and Lexapro.

>

> Forest's review of the testing was mixed. Lexapro

> failed to show improvement in patients when compared

> to a placebo, but it also did not increase the risk

> of suicide. Similarly, the company concluded that

> Celexa did not increase suicide risk, but said it

> will follow FDA recommendations and add a warning to

> its label about the possibility of suicide in

> younger patients.

>

> Ultimately, Celexa has not been given FDA approval

> as a treatment for depression in those under the age

> of 18 and doesn't market the drug towards this

> demographic, so doctors who choose to use it are

> going off label. According to estimates, less than

> 10% of Celexa prescriptions are for underage

> patients.

>

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