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Cymbalta criticized by FDA
-November 10, 2005
According to the FDA, Eli Lilly failed to adequately communicate the serious side effect risks of their drug, Cymbalta, in recent medical journal advertisements. Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI) medication approved by the FDA in 2004 to treat depression and a condition called diabetic peripheral neuropathy which causes nerve damage pain in people with diabetes. This is one of the first antidepressant medications approved by the FDA after studies linked antidepressants with increased suicide risks.
Cymbalta side effect risks appear to be no different from similar medications called SSRIs. All Cymbalta labeling must include a warning which describes the increased risk of suicidal thoughts and behaviors for those vulnerable patients taking this medication. According to the Cymbalta warning, two percent of all children taking Cymbalta will develop suicidal thoughts or actions as a result of this prescription drug. The increased risk of suicide is also a threat to adults that use this medication.
In addition to this serious side effect risk, Cymbalta is also associated with increased risk of allergic reaction, dementia, drug dependency, liver damage (exacerbated by alcohol consumption), increased blood pressure, mania, erectile dysfunction and other sexual disorders, seizures, and more. The common side effects associated with Cymbalta include dry mouth, constipation, sleepiness, increased sweating, nausea, and loss of appetite.
The FDA now states that Eli Lilly is failing to make the risks of Cymbalta clear enough through their ad campaigns in prominent medical journals. The FDA posted on their website the letter they sent to Eli Lilly asking the pharmaceutical company to stop using these ads. The company announced that these ads would not be used in the future.
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