FDA Approves Lilly's Cymbalta for Depression Despite Risk of Suicide

[Guest guest]

> JustSayNo

> Thu, 05 Aug 2004 01:24:01 -0000

 

> [sSRI-Research] FDA Approves Lilly's

> Cymbalta for Depression Despite Risk of Suicide

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org <http://www.ahrp.org>

> FYI

>

> In a display of arrogance and defiance--in the midst

> of federal

> investigations into the marketing of

> antidepressants--the FDA has

> approved Eli Lilly's antidepression drug, Cymbalta

> (duloxetine).

> Lilly's press release announced:

>

> " Cymbalta, a balanced and potent reuptake inhibitor

> of serotonin and

> norepinephrine. "

>

> See:

>

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109 & STORY=/www/story/08-04-200\

4/0002224854 & EDATE=

>

> In earlier clinical trials, Cymbalta had failed to

> demonstrate its

> effectiveness as an antidepressant. Cymbalta acts on

> both

> norepinephrine and serotonin receptors--much like

> the old tricyclic

> antidepressants do. Cymbalta is most closely related

> to Effexor,

> Wyeth's antidepressant.

>

> Effexor's adverse effect--in particular its

> propensity to induce

> suicidality was so apparent that Wyeth took the

> unusual step of

> issuing a warning to health care providers in Aug.

> 2003--seven months

> before the FDA issued a class warning about

> suicidality and SSRI and

> SNRI antidepressants. See Wyeth letter:

> http://www.ahrp.org/risks/effexorLtr082203.html

>

> For more than a decade, Eli Lilly had marketed

> Prozac as a

> breakthrough improvement over the tricyclics because

> Prozac, unlike

> tricyclics, was said to act with " selective "

> precision only on

> serotonin--the exact neuroreceptor that was

> proclaimed to be

> the " most important mood enhancing chemical. " This

> " clean " selective,

> targeted action was said eliminate the unwanted

> side-effects of

> tricyclics. [see Peter Kramer, Listening to Prozac "

> 1993]

>

> In light of Wyeth's warning about the increased

> twofold risk of drug-

> induced hostility, suicidal ideation and self-harm

> in children who

> tested Effexor, FDA's approval of Cymbalta is

> astonishing.

>

> Furthermore, the FDA-approved Cymbalta label is

> irresponsible--

> inasmuch as it refers to " Patients with major

> depressive disorder,

> both adult and pediatric " suggesting pediatric use

> of the drug.

>

> FDA's action raises serious questions about the

> agency's failure to

> put children's lives ahead of Eli Lilly's business

> interests.

>

> Whereas Wyeth at least warned doctors not to

> prescribe Effexor for

> children under 18, the FDA has given Eli Lilly the

> green light to

> suggest that Cymbalta may be used in children.

> http://pi.lilly.com/us/cymbalta-pi.pdf

>

> FDA officials are fully aware that not a single dual

> or triple acting

> antidepressant has shown a benefit for children in

> company controlled

> clinical trials--therefore ANY risk for children is

> unjustified.

>

> FDA's approval of Cymbalta is a case illustration of

> the agency's

> failure to prevent harmful drugs from being

> marketed. FDA officials

> pay more attention to drug manufacturers' marketing

> goals than they

> do to the welfare of children.

>

> Yesterday, Eli Lilly announced its plan to put all

> clinical trial

> data online.

>

> The Alliance for Human Research Protection

> challenges Lilly to put

> ALL the clinical trial data online--including the

> healthy volunteer

> trials. Only when all the data is available for

> independent analysis

> will doctors and the public begin to appreciate the

> nature and

> magnitude of the harmful hidden effects of drugs

> such as: Prozac,

> Zyprexa, and Cymbalta.

>

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>