Cymbalta is an antidepressant manufactured by Eli Lilly & Company – the same company that produced Prozac. Cymbalta was approved by the FDA in late summer of 2004. Not too long after the release of Cymbalta, side effects such as liver damage and suicidal behavior started appearing. Just a few months after the drug was approved, the FDA ordered that a stronger warning about the serious risk of suicide be placed on the drug’s label.
Clinical trials for Cymbalta showed unfavorable results. The rate of suicide attempts was more than doubled for women taking Cymbalta to treat stress urinary incontinence. Cymbalta has not been approved for this usage in the U.S. but it has already been approved for this in 30 other countries.
The controversy over Cymbalta began when a healthy volunteer involved in the trial committed suicide. She did not suffer from depression prior to the study. She was taken off the drug, given a placebo for four days, then killed herself. This lady was the fifth patient to commit suicide after taking Cymbalta in clinical trials.
Along with the increased risk of suicide, Cymbalta has also been linked to possible liver damage.
Eli Lilly allegedly offered health facilities & other purchasers of large quantities of antidepressants a 5% discount in drug prices for Cymbalta if they agreed to refrain from making unflattering statements about the risks associated with the drug when discussing with medical professionals.
The controversy surrounding Cymbalta continues to grow. Although the FDA is making sure the proper warnings are being placed on the drug’s label, the overall situation is just another example of questionable practices in the approval process that allow drugs to be released to the market before an adequate amount of clinical testing has been done. The FDA apparently has serious concerns about the safety of Cymbalta, yet they have still allowed it on the market.
Patients taking Cymbalta should also be monitored regularly for high blood pressure. The increases do not appear to post an acute risk although patients’ blood pressures could easily drift into ranges that are associated with increased risk of heart disease and stroke.