October 26

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

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

Wed, 4 Aug 2004

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 -2004/0002224854&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: https://ahrp.org/risks/effexorLtr082203.php

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

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